Title 21

Volume 8 CHAPTER I SUBCHAP H

Subchapter H - Medical Devices

21:8.0.1.1.1PART 800
PART 800 - GENERAL
21:8.0.1.1.1.1SUBPART A
Subpart A [Reserved]
21:8.0.1.1.1.2SUBPART B
Subpart B - Requirements for Specific Medical Devices
21:8.0.1.1.1.2.1.1SECTION 800.10
     800.10 Contact lens solutions; sterility.
21:8.0.1.1.1.2.1.2SECTION 800.12
     800.12 Contact lens solutions and tablets; tamper-resistant packaging.
21:8.0.1.1.1.2.1.3SECTION 800.20
     800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration.
21:8.0.1.1.1.3SUBPART C
Subpart C - Administrative Practices and Procedures
21:8.0.1.1.1.3.1.1SECTION 800.55
     800.55 Administrative detention.
21:8.0.1.1.1.3.1.2SECTION 800.75
     800.75 Requests for supervisory review of certain decisions made by the Center for Devices and Radiological Health.
21:8.0.1.1.2PART 801
PART 801 - LABELING
21:8.0.1.1.2.1SUBPART A
Subpart A - General Labeling Provisions
21:8.0.1.1.2.1.1.1SECTION 801.1
     801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
21:8.0.1.1.2.1.1.2SECTION 801.3
     801.3 Definitions.
21:8.0.1.1.2.1.1.3SECTION 801.4
     801.4 Meaning of intended uses.
21:8.0.1.1.2.1.1.4SECTION 801.5
     801.5 Medical devices; adequate directions for use.
21:8.0.1.1.2.1.1.5SECTION 801.6
     801.6 Medical devices; misleading statements.
21:8.0.1.1.2.1.1.6SECTION 801.15
     801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
21:8.0.1.1.2.1.1.7SECTION 801.16
     801.16 Medical devices; Spanish-language version of certain required statements.
21:8.0.1.1.2.1.1.8SECTION 801.18
     801.18 Format of dates provided on a medical device label.
21:8.0.1.1.2.2SUBPART B
Subpart B - Labeling Requirements for Unique Device Identification
21:8.0.1.1.2.2.1.1SECTION 801.20
     801.20 Label to bear a unique device identifier.
21:8.0.1.1.2.2.1.2SECTION 801.30
     801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
21:8.0.1.1.2.2.1.3SECTION 801.35
     801.35 Voluntary labeling of a device with a unique device identifier.
21:8.0.1.1.2.2.1.4SECTION 801.40
     801.40 Form of a unique device identifier.
21:8.0.1.1.2.2.1.5SECTION 801.45
     801.45 Devices that must be directly marked with a unique device identifier.
21:8.0.1.1.2.2.1.6SECTION 801.50
     801.50 Labeling requirements for stand-alone software.
21:8.0.1.1.2.2.1.7SECTION 801.55
     801.55 Request for an exception from or alternative to a unique device identifier requirement.
21:8.0.1.1.2.2.1.8SECTION 801.57
     801.57 Discontinuation of legacy FDA identification numbers assigned to devices.
21:8.0.1.1.2.3SUBPART C
Subpart C - Labeling Requirements for Over-the-Counter Devices
21:8.0.1.1.2.3.1.1SECTION 801.60
     801.60 Principal display panel.
21:8.0.1.1.2.3.1.2SECTION 801.61
     801.61 Statement of identity.
21:8.0.1.1.2.3.1.3SECTION 801.62
     801.62 Declaration of net quantity of contents.
21:8.0.1.1.2.3.1.4SECTION 801.63
     801.63 Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.
21:8.0.1.1.2.4SUBPART D
Subpart D - Exemptions From Adequate Directions for Use
21:8.0.1.1.2.4.1.1SECTION 801.109
     801.109 Prescription devices.
21:8.0.1.1.2.4.1.2SECTION 801.110
     801.110 Retail exemption for prescription devices.
21:8.0.1.1.2.4.1.3SECTION 801.116
     801.116 Medical devices having commonly known directions.
21:8.0.1.1.2.4.1.4SECTION 801.119
     801.119 In vitro diagnostic products.
21:8.0.1.1.2.4.1.5SECTION 801.122
     801.122 Medical devices for processing, repacking, or manufacturing.
21:8.0.1.1.2.4.1.6SECTION 801.125
     801.125 Medical devices for use in teaching, law enforcement, research, and analysis.
21:8.0.1.1.2.4.1.7SECTION 801.127
     801.127 Medical devices; expiration of exemptions.
21:8.0.1.1.2.4.1.8SECTION 801.128
     801.128 Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
21:8.0.1.1.2.5SUBPART E
Subpart E - Other Exemptions
21:8.0.1.1.2.5.1.1SECTION 801.150
     801.150 Medical devices; processing, labeling, or repacking.
21:8.0.1.1.2.6SUBPART F
Subparts F-G [Reserved]
21:8.0.1.1.2.7SUBPART H
Subpart H - Special Requirements for Specific Devices
21:8.0.1.1.2.7.1.1SECTION 801.405
     801.405 Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
21:8.0.1.1.2.7.1.2SECTION 801.410
     801.410 Use of impact-resistant lenses in eyeglasses and sunglasses.
21:8.0.1.1.2.7.1.3SECTION 801.415
     801.415 Maximum acceptable level of ozone.
21:8.0.1.1.2.7.1.4SECTION 801.417
     801.417 Chlorofluorocarbon propellants.
21:8.0.1.1.2.7.1.5SECTION 801.420
     801.420 Hearing aid devices; professional and patient labeling.
21:8.0.1.1.2.7.1.6SECTION 801.421
     801.421 Hearing aid devices; conditions for sale.
21:8.0.1.1.2.7.1.7SECTION 801.430
     801.430 User labeling for menstrual tampons.
21:8.0.1.1.2.7.1.8SECTION 801.433
     801.433 Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
21:8.0.1.1.2.7.1.9SECTION 801.435
     801.435 User labeling for latex condoms.
21:8.0.1.1.2.7.1.10SECTION 801.437
     801.437 User labeling for devices that contain natural rubber.
21:8.0.1.1.3PART 803
PART 803 - MEDICAL DEVICE REPORTING
21:8.0.1.1.3.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.3.1.1.1SECTION 803.1
     803.1 What does this part cover
21:8.0.1.1.3.1.1.2SECTION 803.3
     803.3 How does FDA define the terms used in this part
21:8.0.1.1.3.1.1.3SECTION 803.9
     803.9 What information from the reports do we disclose to the public
21:8.0.1.1.3.1.1.4SECTION 803.10
     803.10 Generally, what are the reporting requirements that apply to me
21:8.0.1.1.3.1.1.5SECTION 803.11
     803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms
21:8.0.1.1.3.1.1.6SECTION 803.12
     803.12 How do I submit initial and supplemental or followup reports
21:8.0.1.1.3.1.1.7SECTION 803.13
     803.13 Do I need to submit reports in English
21:8.0.1.1.3.1.1.8SECTION 803.15
     803.15 How will I know if you require more information about my medical device report
21:8.0.1.1.3.1.1.9SECTION 803.16
     803.16 When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event
21:8.0.1.1.3.1.1.10SECTION 803.17
     803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me
21:8.0.1.1.3.1.1.11SECTION 803.18
     803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me
21:8.0.1.1.3.1.1.12SECTION 803.19
     803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements
21:8.0.1.1.3.2SUBPART B
Subpart B - Generally Applicable Requirements for Individual Adverse Event Reports
21:8.0.1.1.3.2.1.1SECTION 803.20
     803.20 How do I complete and submit an individual adverse event report
21:8.0.1.1.3.2.1.2SECTION 803.21
     803.21 Where can I find the reporting codes for adverse events that I use with medical device reports
21:8.0.1.1.3.2.1.3SECTION 803.22
     803.22 What are the circumstances in which I am not required to file a report
21:8.0.1.1.3.2.1.4SECTION 803.23
     803.23 Where can I find information on how to prepare and submit an MDR in electronic format
21:8.0.1.1.3.3SUBPART C
Subpart C - User Facility Reporting Requirements
21:8.0.1.1.3.3.1.1SECTION 803.30
     803.30 If I am a user facility, what reporting requirements apply to me
21:8.0.1.1.3.3.1.2SECTION 803.32
     803.32 If I am a user facility, what information must I submit in my individual adverse event reports
21:8.0.1.1.3.3.1.3SECTION 803.33
     803.33 If I am a user facility, what must I include when I submit an annual report
21:8.0.1.1.3.4SUBPART D
Subpart D - Importer Reporting Requirements
21:8.0.1.1.3.4.1.1SECTION 803.40
     803.40 If I am an importer, what reporting requirements apply to me
21:8.0.1.1.3.4.1.2SECTION 803.42
     803.42 If I am an importer, what information must I submit in my individual adverse event reports
21:8.0.1.1.3.5SUBPART E
Subpart E - Manufacturer Reporting Requirements
21:8.0.1.1.3.5.1.1SECTION 803.50
     803.50 If I am a manufacturer, what reporting requirements apply to me
21:8.0.1.1.3.5.1.2SECTION 803.52
     803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports
21:8.0.1.1.3.5.1.3SECTION 803.53
     803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report
21:8.0.1.1.3.5.1.4SECTION 803.56
     803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports
21:8.0.1.1.3.5.1.5SECTION 803.58
     803.58 Foreign manufacturers.
21:8.0.1.1.4PART 806
PART 806 - MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
21:8.0.1.1.4.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.4.1.1.1SECTION 806.1
     806.1 Scope.
21:8.0.1.1.4.1.1.2SECTION 806.2
     806.2 Definitions.
21:8.0.1.1.4.2SUBPART B
Subpart B - Reports and Records
21:8.0.1.1.4.2.1.1SECTION 806.10
     806.10 Reports of corrections and removals.
21:8.0.1.1.4.2.1.2SECTION 806.20
     806.20 Records of corrections and removals not required to be reported.
21:8.0.1.1.4.2.1.3SECTION 806.30
     806.30 FDA access to records.
21:8.0.1.1.4.2.1.4SECTION 806.40
     806.40 Public availability of reports.
21:8.0.1.1.5PART 807
PART 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
21:8.0.1.1.5.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.5.1.1.1SECTION 807.3
     807.3 Definitions.
21:8.0.1.1.5.2SUBPART B
Subpart B - Procedures for Device Establishments
21:8.0.1.1.5.2.1.1SECTION 807.20
     807.20 Who must register and submit a device list
21:8.0.1.1.5.2.1.2SECTION 807.21
     807.21 How to register establishments and list devices.
21:8.0.1.1.5.2.1.3SECTION 807.22
     807.22 Times for establishment registration and device listing.
21:8.0.1.1.5.2.1.4SECTION 807.25
     807.25 Information required for device establishment registration and device listing.
21:8.0.1.1.5.2.1.5SECTION 807.26
     807.26 Additional listing information.
21:8.0.1.1.5.2.1.6SECTION 807.28
     807.28 Updating device listing information.
21:8.0.1.1.5.2.1.7SECTION 807.34
     807.34 Summary of requirements for owners or operators granted a waiver from submitting required information electronically.
21:8.0.1.1.5.2.1.8SECTION 807.35
     807.35 Notification of registrant.
21:8.0.1.1.5.2.1.9SECTION 807.37
     807.37 Public availability of establishment registration and device listing information.
21:8.0.1.1.5.2.1.10SECTION 807.39
     807.39 Misbranding by reference to establishment registration or to registration number.
21:8.0.1.1.5.3SUBPART C
Subpart C - Procedures for Foreign Device Establishments
21:8.0.1.1.5.3.1.1SECTION 807.40
     807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.
21:8.0.1.1.5.3.1.2SECTION 807.41
     807.41 Identification of importers and persons who import or offer for import.
21:8.0.1.1.5.4SUBPART D
Subpart D - Exemptions
21:8.0.1.1.5.4.1.1SECTION 807.65
     807.65 Exemptions for device establishments.
21:8.0.1.1.5.5SUBPART E
Subpart E - Premarket Notification Procedures
21:8.0.1.1.5.5.1.1SECTION 807.81
     807.81 When a premarket notification submission is required.
21:8.0.1.1.5.5.1.2SECTION 807.85
     807.85 Exemption from premarket notification.
21:8.0.1.1.5.5.1.3SECTION 807.87
     807.87 Information required in a premarket notification submission.
21:8.0.1.1.5.5.1.4SECTION 807.90
     807.90 Format of a premarket notification submission.
21:8.0.1.1.5.5.1.5SECTION 807.92
     807.92 Content and format of a 510(k) summary.
21:8.0.1.1.5.5.1.6SECTION 807.93
     807.93 Content and format of a 510(k) statement.
21:8.0.1.1.5.5.1.7SECTION 807.94
     807.94 Format of a class III certification.
21:8.0.1.1.5.5.1.8SECTION 807.95
     807.95 Confidentiality of information.
21:8.0.1.1.5.5.1.9SECTION 807.97
     807.97 Misbranding by reference to premarket notification.
21:8.0.1.1.5.5.1.10SECTION 807.100
     807.100 FDA action on a premarket notification.
21:8.0.1.1.6PART 808
PART 808 - EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
21:8.0.1.1.6.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.6.1.1.1SECTION 808.1
     808.1 Scope.
21:8.0.1.1.6.1.1.2SECTION 808.3
     808.3 Definitions.
21:8.0.1.1.6.1.1.3SECTION 808.5
     808.5 Advisory opinions.
21:8.0.1.1.6.2SUBPART B
Subpart B - Exemption Procedures
21:8.0.1.1.6.2.1.1SECTION 808.20
     808.20 Application.
21:8.0.1.1.6.2.1.2SECTION 808.25
     808.25 Procedures for processing an application.
21:8.0.1.1.6.2.1.3SECTION 808.35
     808.35 Revocation of an exemption.
21:8.0.1.1.6.3SUBPART C
Subpart C - Listing of Specific State and Local Exemptions
21:8.0.1.1.6.3.1.1SECTION 808.53
     808.53 Arizona.
21:8.0.1.1.6.3.1.2SECTION 808.55
     808.55 California.
21:8.0.1.1.6.3.1.3SECTION 808.57
     808.57 Connecticut.
21:8.0.1.1.6.3.1.4SECTION 808.59
     808.59 Florida.
21:8.0.1.1.6.3.1.5SECTION 808.61
     808.61 Hawaii.
21:8.0.1.1.6.3.1.6SECTION 808.67
     808.67 Kentucky.
21:8.0.1.1.6.3.1.7SECTION 808.69
     808.69 Maine.
21:8.0.1.1.6.3.1.8SECTION 808.71
     808.71 Massachusetts.
21:8.0.1.1.6.3.1.9SECTION 808.73
     808.73 Minnesota.
21:8.0.1.1.6.3.1.10SECTION 808.74
     808.74 Mississippi.
21:8.0.1.1.6.3.1.11SECTION 808.77
     808.77 Nebraska.
21:8.0.1.1.6.3.1.12SECTION 808.80
     808.80 New Jersey.
21:8.0.1.1.6.3.1.13SECTION 808.81
     808.81 New Mexico.
21:8.0.1.1.6.3.1.14SECTION 808.82
     808.82 New York.
21:8.0.1.1.6.3.1.15SECTION 808.85
     808.85 Ohio.
21:8.0.1.1.6.3.1.16SECTION 808.87
     808.87 Oregon.
21:8.0.1.1.6.3.1.17SECTION 808.88
     808.88 Pennsylvania.
21:8.0.1.1.6.3.1.18SECTION 808.89
     808.89 Rhode Island.
21:8.0.1.1.6.3.1.19SECTION 808.93
     808.93 Texas.
21:8.0.1.1.6.3.1.20SECTION 808.97
     808.97 Washington.
21:8.0.1.1.6.3.1.21SECTION 808.98
     808.98 West Virginia.
21:8.0.1.1.6.3.1.22SECTION 808.101
     808.101 District of Columbia.
21:8.0.1.1.7PART 809
PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
21:8.0.1.1.7.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.7.1.1.1SECTION 809.3
     809.3 Definitions.
21:8.0.1.1.7.1.1.2SECTION 809.4
     809.4 Confidentiality of submitted information.
21:8.0.1.1.7.2SUBPART B
Subpart B - Labeling
21:8.0.1.1.7.2.1.1SECTION 809.10
     809.10 Labeling for in vitro diagnostic products.
21:8.0.1.1.7.2.1.2SECTION 809.11
     809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
21:8.0.1.1.7.3SUBPART C
Subpart C - Requirements for Manufacturers and Producers
21:8.0.1.1.7.3.1.1SECTION 809.20
     809.20 General requirements for manufacturers and producers of in vitro diagnostic products.
21:8.0.1.1.7.3.1.2SECTION 809.30
     809.30 Restrictions on the sale, distribution and use of analyte specific reagents.
21:8.0.1.1.7.3.1.3SECTION 809.40
     809.40 Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.
21:8.0.1.1.8PART 810
PART 810 - MEDICAL DEVICE RECALL AUTHORITY
21:8.0.1.1.8.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.8.1.1.1SECTION 810.1
     810.1 Scope.
21:8.0.1.1.8.1.1.2SECTION 810.2
     810.2 Definitions.
21:8.0.1.1.8.1.1.3SECTION 810.3
     810.3 Computation of time.
21:8.0.1.1.8.1.1.4SECTION 810.4
     810.4 Service of orders.
21:8.0.1.1.8.2SUBPART B
Subpart B - Mandatory Medical Device Recall Procedures
21:8.0.1.1.8.2.1.1SECTION 810.10
     810.10 Cease distribution and notification order.
21:8.0.1.1.8.2.1.2SECTION 810.11
     810.11 Regulatory hearing.
21:8.0.1.1.8.2.1.3SECTION 810.12
     810.12 Written request for review of cease distribution and notification order.
21:8.0.1.1.8.2.1.4SECTION 810.13
     810.13 Mandatory recall order.
21:8.0.1.1.8.2.1.5SECTION 810.14
     810.14 Cease distribution and notification or mandatory recall strategy.
21:8.0.1.1.8.2.1.6SECTION 810.15
     810.15 Communications concerning a cease distribution and notification or mandatory recall order.
21:8.0.1.1.8.2.1.7SECTION 810.16
     810.16 Cease distribution and notification or mandatory recall order status reports.
21:8.0.1.1.8.2.1.8SECTION 810.17
     810.17 Termination of a cease distribution and notification or mandatory recall order.
21:8.0.1.1.8.2.1.9SECTION 810.18
     810.18 Public notice.
21:8.0.1.1.9PART 812
PART 812 - INVESTIGATIONAL DEVICE EXEMPTIONS
21:8.0.1.1.9.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.9.1.1.1SECTION 812.1
     812.1 Scope.
21:8.0.1.1.9.1.1.2SECTION 812.2
     812.2 Applicability.
21:8.0.1.1.9.1.1.3SECTION 812.3
     812.3 Definitions.
21:8.0.1.1.9.1.1.4SECTION 812.5
     812.5 Labeling of investigational devices.
21:8.0.1.1.9.1.1.5SECTION 812.7
     812.7 Prohibition of promotion and other practices.
21:8.0.1.1.9.1.1.6SECTION 812.10
     812.10 Waivers.
21:8.0.1.1.9.1.1.7SECTION 812.18
     812.18 Import and export requirements.
21:8.0.1.1.9.1.1.8SECTION 812.19
     812.19 Address for IDE correspondence.
21:8.0.1.1.9.2SUBPART B
Subpart B - Application and Administrative Action
21:8.0.1.1.9.2.1.1SECTION 812.20
     812.20 Application.
21:8.0.1.1.9.2.1.2SECTION 812.25
     812.25 Investigational plan.
21:8.0.1.1.9.2.1.3SECTION 812.27
     812.27 Report of prior investigations.
21:8.0.1.1.9.2.1.4SECTION 812.28
     812.28 Acceptance of data from clinical investigations conducted outside the United States.
21:8.0.1.1.9.2.1.5SECTION 812.30
     812.30 FDA action on applications.
21:8.0.1.1.9.2.1.6SECTION 812.35
     812.35 Supplemental applications.
21:8.0.1.1.9.2.1.7SECTION 812.36
     812.36 Treatment use of an investigational device.
21:8.0.1.1.9.2.1.8SECTION 812.38
     812.38 Confidentiality of data and information.
21:8.0.1.1.9.3SUBPART C
Subpart C - Responsibilities of Sponsors
21:8.0.1.1.9.3.1.1SECTION 812.40
     812.40 General responsibilities of sponsors.
21:8.0.1.1.9.3.1.2SECTION 812.42
     812.42 FDA and IRB approval.
21:8.0.1.1.9.3.1.3SECTION 812.43
     812.43 Selecting investigators and monitors.
21:8.0.1.1.9.3.1.4SECTION 812.45
     812.45 Informing investigators.
21:8.0.1.1.9.3.1.5SECTION 812.46
     812.46 Monitoring investigations.
21:8.0.1.1.9.3.1.6SECTION 812.47
     812.47 Emergency research under § 50.24 of this chapter.
21:8.0.1.1.9.4SUBPART D
Subpart D - IRB Review and Approval
21:8.0.1.1.9.4.1.1SECTION 812.60
     812.60 IRB composition, duties, and functions.
21:8.0.1.1.9.4.1.2SECTION 812.62
     812.62 IRB approval.
21:8.0.1.1.9.4.1.3SECTION 812.64
     812.64 IRB's continuing review.
21:8.0.1.1.9.4.1.4SECTION 812.65
     812.65 [Reserved]
21:8.0.1.1.9.4.1.5SECTION 812.66
     812.66 Significant risk device determinations.
21:8.0.1.1.9.5SUBPART E
Subpart E - Responsibilities of Investigators
21:8.0.1.1.9.5.1.1SECTION 812.100
     812.100 General responsibilities of investigators.
21:8.0.1.1.9.5.1.2SECTION 812.110
     812.110 Specific responsibilities of investigators.
21:8.0.1.1.9.5.1.3SECTION 812.119
     812.119 Disqualification of a clinical investigator.
21:8.0.1.1.9.6SUBPART F
Subpart F [Reserved]
21:8.0.1.1.9.7SUBPART G
Subpart G - Records and Reports
21:8.0.1.1.9.7.1.1SECTION 812.140
     812.140 Records.
21:8.0.1.1.9.7.1.2SECTION 812.145
     812.145 Inspections.
21:8.0.1.1.9.7.1.3SECTION 812.150
     812.150 Reports.
21:8.0.1.1.10PART 813
PART 813 [RESERVED]
21:8.0.1.1.11PART 814
PART 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
21:8.0.1.1.11.1SUBPART A
Subpart A - General
21:8.0.1.1.11.1.1.1SECTION 814.1
     814.1 Scope.
21:8.0.1.1.11.1.1.2SECTION 814.2
     814.2 Purpose.
21:8.0.1.1.11.1.1.3SECTION 814.3
     814.3 Definitions.
21:8.0.1.1.11.1.1.4SECTION 814.9
     814.9 Confidentiality of data and information in a premarket approval application (PMA) file.
21:8.0.1.1.11.1.1.5SECTION 814.15
     814.15 Research conducted outside the United States.
21:8.0.1.1.11.1.1.6SECTION 814.17
     814.17 Service of orders.
21:8.0.1.1.11.1.1.7SECTION 814.19
     814.19 Product development protocol (PDP).
21:8.0.1.1.11.2SUBPART B
Subpart B - Premarket Approval Application (PMA)
21:8.0.1.1.11.2.1.1SECTION 814.20
     814.20 Application.
21:8.0.1.1.11.2.1.2SECTION 814.37
     814.37 PMA amendments and resubmitted PMAs.
21:8.0.1.1.11.2.1.3SECTION 814.39
     814.39 PMA supplements.
21:8.0.1.1.11.3SUBPART C
Subpart C - FDA Action on a PMA
21:8.0.1.1.11.3.1.1SECTION 814.40
     814.40 Time frames for reviewing a PMA.
21:8.0.1.1.11.3.1.2SECTION 814.42
     814.42 Filing a PMA.
21:8.0.1.1.11.3.1.3SECTION 814.44
     814.44 Procedures for review of a PMA.
21:8.0.1.1.11.3.1.4SECTION 814.45
     814.45 Denial of approval of a PMA.
21:8.0.1.1.11.3.1.5SECTION 814.46
     814.46 Withdrawal of approval of a PMA.
21:8.0.1.1.11.3.1.6SECTION 814.47
     814.47 Temporary suspension of approval of a PMA.
21:8.0.1.1.11.4SUBPART D
Subpart D - Administrative Review [Reserved]
21:8.0.1.1.11.5SUBPART E
Subpart E - Postapproval Requirements
21:8.0.1.1.11.5.1.1SECTION 814.80
     814.80 General.
21:8.0.1.1.11.5.1.2SECTION 814.82
     814.82 Postapproval requirements.
21:8.0.1.1.11.5.1.3SECTION 814.84
     814.84 Reports.
21:8.0.1.1.11.6SUBPART F
Subparts F-G [Reserved]
21:8.0.1.1.11.7SUBPART H
Subpart H - Humanitarian Use Devices
21:8.0.1.1.11.7.1.1SECTION 814.100
     814.100 Purpose and scope.
21:8.0.1.1.11.7.1.2SECTION 814.102
     814.102 Designation of HUD status.
21:8.0.1.1.11.7.1.3SECTION 814.104
     814.104 Original applications.
21:8.0.1.1.11.7.1.4SECTION 814.106
     814.106 HDE amendments and resubmitted HDE's.
21:8.0.1.1.11.7.1.5SECTION 814.108
     814.108 Supplemental applications.
21:8.0.1.1.11.7.1.6SECTION 814.110
     814.110 New indications for use.
21:8.0.1.1.11.7.1.7SECTION 814.112
     814.112 Filing an HDE.
21:8.0.1.1.11.7.1.8SECTION 814.114
     814.114 Timeframes for reviewing an HDE.
21:8.0.1.1.11.7.1.9SECTION 814.116
     814.116 Procedures for review of an HDE.
21:8.0.1.1.11.7.1.10SECTION 814.118
     814.118 Denial of approval or withdrawal of approval of an HDE.
21:8.0.1.1.11.7.1.11SECTION 814.120
     814.120 Temporary suspension of approval of an HDE.
21:8.0.1.1.11.7.1.12SECTION 814.122
     814.122 Confidentiality of data and information.
21:8.0.1.1.11.7.1.13SECTION 814.124
     814.124 Institutional Review Board requirements.
21:8.0.1.1.11.7.1.14SECTION 814.126
     814.126 Postapproval requirements and reports.
21:8.0.1.1.12PART 820
PART 820 - QUALITY SYSTEM REGULATION
21:8.0.1.1.12.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.12.1.1.1SECTION 820.1
     820.1 Scope.
21:8.0.1.1.12.1.1.2SECTION 820.3
     820.3 Definitions.
21:8.0.1.1.12.1.1.3SECTION 820.5
     820.5 Quality system.
21:8.0.1.1.12.2SUBPART B
Subpart B - Quality System Requirements
21:8.0.1.1.12.2.1.1SECTION 820.20
     820.20 Management responsibility.
21:8.0.1.1.12.2.1.2SECTION 820.22
     820.22 Quality audit.
21:8.0.1.1.12.2.1.3SECTION 820.25
     820.25 Personnel.
21:8.0.1.1.12.3SUBPART C
Subpart C - Design Controls
21:8.0.1.1.12.3.1.1SECTION 820.30
     820.30 Design controls.
21:8.0.1.1.12.4SUBPART D
Subpart D - Document Controls
21:8.0.1.1.12.4.1.1SECTION 820.40
     820.40 Document controls.
21:8.0.1.1.12.5SUBPART E
Subpart E - Purchasing Controls
21:8.0.1.1.12.5.1.1SECTION 820.50
     820.50 Purchasing controls.
21:8.0.1.1.12.6SUBPART F
Subpart F - Identification and Traceability
21:8.0.1.1.12.6.1.1SECTION 820.60
     820.60 Identification.
21:8.0.1.1.12.6.1.2SECTION 820.65
     820.65 Traceability.
21:8.0.1.1.12.7SUBPART G
Subpart G - Production and Process Controls
21:8.0.1.1.12.7.1.1SECTION 820.70
     820.70 Production and process controls.
21:8.0.1.1.12.7.1.2SECTION 820.72
     820.72 Inspection, measuring, and test equipment.
21:8.0.1.1.12.7.1.3SECTION 820.75
     820.75 Process validation.
21:8.0.1.1.12.8SUBPART H
Subpart H - Acceptance Activities
21:8.0.1.1.12.8.1.1SECTION 820.80
     820.80 Receiving, in-process, and finished device acceptance.
21:8.0.1.1.12.8.1.2SECTION 820.86
     820.86 Acceptance status.
21:8.0.1.1.12.9SUBPART I
Subpart I - Nonconforming Product
21:8.0.1.1.12.9.1.1SECTION 820.90
     820.90 Nonconforming product.
21:8.0.1.1.12.10SUBPART J
Subpart J - Corrective and Preventive Action
21:8.0.1.1.12.10.1.1SECTION 820.100
     820.100 Corrective and preventive action.
21:8.0.1.1.12.11SUBPART K
Subpart K - Labeling and Packaging Control
21:8.0.1.1.12.11.1.1SECTION 820.120
     820.120 Device labeling.
21:8.0.1.1.12.11.1.2SECTION 820.130
     820.130 Device packaging.
21:8.0.1.1.12.12SUBPART L
Subpart L - Handling, Storage, Distribution, and Installation
21:8.0.1.1.12.12.1.1SECTION 820.140
     820.140 Handling.
21:8.0.1.1.12.12.1.2SECTION 820.150
     820.150 Storage.
21:8.0.1.1.12.12.1.3SECTION 820.160
     820.160 Distribution.
21:8.0.1.1.12.12.1.4SECTION 820.170
     820.170 Installation.
21:8.0.1.1.12.13SUBPART M
Subpart M - Records
21:8.0.1.1.12.13.1.1SECTION 820.180
     820.180 General requirements.
21:8.0.1.1.12.13.1.2SECTION 820.181
     820.181 Device master record.
21:8.0.1.1.12.13.1.3SECTION 820.184
     820.184 Device history record.
21:8.0.1.1.12.13.1.4SECTION 820.186
     820.186 Quality system record.
21:8.0.1.1.12.13.1.5SECTION 820.198
     820.198 Complaint files.
21:8.0.1.1.12.14SUBPART N
Subpart N - Servicing
21:8.0.1.1.12.14.1.1SECTION 820.200
     820.200 Servicing.
21:8.0.1.1.12.15SUBPART O
Subpart O - Statistical Techniques
21:8.0.1.1.12.15.1.1SECTION 820.250
     820.250 Statistical techniques.
21:8.0.1.1.13PART 821
PART 821 - MEDICAL DEVICE TRACKING REQUIREMENTS
21:8.0.1.1.13.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.13.1.1.1SECTION 821.1
     821.1 Scope.
21:8.0.1.1.13.1.1.2SECTION 821.2
     821.2 Exemptions and variances.
21:8.0.1.1.13.1.1.3SECTION 821.3
     821.3 Definitions.
21:8.0.1.1.13.1.1.4SECTION 821.4
     821.4 Imported devices.
21:8.0.1.1.13.2SUBPART B
Subpart B - Tracking Requirements
21:8.0.1.1.13.2.1.1SECTION 821.20
     821.20 Devices subject to tracking.
21:8.0.1.1.13.2.1.2SECTION 821.25
     821.25 Device tracking system and content requirements: manufacturer requirements.
21:8.0.1.1.13.3SUBPART C
Subpart C - Additional Requirements and Responsibilities
21:8.0.1.1.13.3.1.1SECTION 821.30
     821.30 Tracking obligations of persons other than device manufacturers: distributor requirements.
21:8.0.1.1.13.4SUBPART D
Subpart D - Records and Inspections
21:8.0.1.1.13.4.1.1SECTION 821.50
     821.50 Availability.
21:8.0.1.1.13.4.1.2SECTION 821.55
     821.55 Confidentiality.
21:8.0.1.1.13.4.1.3SECTION 821.60
     821.60 Retention of records.
21:8.0.1.1.14PART 822
PART 822 - POSTMARKET SURVEILLANCE
21:8.0.1.1.14.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.14.1.1.1SECTION 822.1
     822.1 What does this part cover
21:8.0.1.1.14.1.1.2SECTION 822.2
     822.2 What is the purpose of this part
21:8.0.1.1.14.1.1.3SECTION 822.3
     822.3 How do you define the terms used in this part
21:8.0.1.1.14.1.1.4SECTION 822.4
     822.4 Does this part apply to me
21:8.0.1.1.14.2SUBPART B
Subpart B - Notification
21:8.0.1.1.14.2.1.1SECTION 822.5
     822.5 How will I know if I must conduct postmarket surveillance
21:8.0.1.1.14.2.1.2SECTION 822.6
     822.6 When will you notify me that I am required to conduct postmarket surveillance
21:8.0.1.1.14.2.1.3SECTION 822.7
     822.7 What should I do if I do not agree that postmarket surveillance is appropriate
21:8.0.1.1.14.3SUBPART C
Subpart C - Postmarket Surveillance Plan
21:8.0.1.1.14.3.1.1SECTION 822.8
     822.8 When, where, and how must I submit my postmarket surveillance plan
21:8.0.1.1.14.3.1.2SECTION 822.9
     822.9 What must I include in my submission
21:8.0.1.1.14.3.1.3SECTION 822.10
     822.10 What must I include in my surveillance plan
21:8.0.1.1.14.3.1.4SECTION 822.11
     822.11 What should I consider when designing my plan to conduct postmarket surveillance
21:8.0.1.1.14.3.1.5SECTION 822.12
     822.12 Do you have any information that will help me prepare my submission or design my postmarket surveillance plan
21:8.0.1.1.14.3.1.6SECTION 822.13
     822.13 [Reserved]
21:8.0.1.1.14.3.1.7SECTION 822.14
     822.14 May I reference information previously submitted instead of submitting it again
21:8.0.1.1.14.3.1.8SECTION 822.15
     822.15 How long must I conduct postmarket surveillance of my device
21:8.0.1.1.14.4SUBPART D
Subpart D - FDA Review and Action
21:8.0.1.1.14.4.1.1SECTION 822.16
     822.16 What will you consider in the review of my submission
21:8.0.1.1.14.4.1.2SECTION 822.17
     822.17 How long will your review of my submission take
21:8.0.1.1.14.4.1.3SECTION 822.18
     822.18 How will I be notified of your decision
21:8.0.1.1.14.4.1.4SECTION 822.19
     822.19 What kinds of decisions may you make
21:8.0.1.1.14.4.1.5SECTION 822.20
     822.20 What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct surveillance in accordance with my approved plan
21:8.0.1.1.14.4.1.6SECTION 822.21
     822.21 What must I do if I want to make changes to my postmarket surveillance plan after you have approved it
21:8.0.1.1.14.4.1.7SECTION 822.22
     822.22 What recourse do I have if I do not agree with your decision
21:8.0.1.1.14.4.1.8SECTION 822.23
     822.23 Is the information in my submission considered confidential
21:8.0.1.1.14.5SUBPART E
Subpart E - Responsibilities of Manufacturers
21:8.0.1.1.14.5.1.1SECTION 822.24
     822.24 What are my responsibilities once I am notified that I am required to conduct postmarket surveillance
21:8.0.1.1.14.5.1.2SECTION 822.25
     822.25 What are my responsibilities after my postmarket surveillance plan has been approved
21:8.0.1.1.14.5.1.3SECTION 822.26
     822.26 If my company changes ownership, what must I do
21:8.0.1.1.14.5.1.4SECTION 822.27
     822.27 If I go out of business, what must I do
21:8.0.1.1.14.5.1.5SECTION 822.28
     822.28 If I stop marketing the device subject to postmarket surveillance, what must I do
21:8.0.1.1.14.6SUBPART F
Subpart F - Waivers and Exemptions
21:8.0.1.1.14.6.1.1SECTION 822.29
     822.29 May I request a waiver of a specific requirement of this part
21:8.0.1.1.14.6.1.2SECTION 822.30
     822.30 May I request exemption from the requirement to conduct postmarket surveillance
21:8.0.1.1.14.7SUBPART G
Subpart G - Records and Reports
21:8.0.1.1.14.7.1.1SECTION 822.31
     822.31 What records am I required to keep
21:8.0.1.1.14.7.1.2SECTION 822.32
     822.32 What records are the investigators in my surveillance plan required to keep
21:8.0.1.1.14.7.1.3SECTION 822.33
     822.33 How long must we keep the records
21:8.0.1.1.14.7.1.4SECTION 822.34
     822.34 What must I do with the records if the sponsor of the plan or an investigator in the plan changes
21:8.0.1.1.14.7.1.5SECTION 822.35
     822.35 Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan
21:8.0.1.1.14.7.1.6SECTION 822.36
     822.36 Can you inspect and copy the records related to my postmarket surveillance plan
21:8.0.1.1.14.7.1.7SECTION 822.37
     822.37 Under what circumstances would you inspect records identifying subjects
21:8.0.1.1.14.7.1.8SECTION 822.38
     822.38 What reports must I submit to you
21:8.0.1.1.15PART 830
PART 830 - UNIQUE DEVICE IDENTIFICATION
21:8.0.1.1.15.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.15.1.1.1SECTION 830.3
     830.3 Definitions.
21:8.0.1.1.15.2SUBPART B
Subpart B - Requirements for a Unique Device Identifier
21:8.0.1.1.15.2.1.1SECTION 830.10
     830.10 Incorporation by reference.
21:8.0.1.1.15.2.1.2SECTION 830.20
     830.20 Requirements for a unique device identifier.
21:8.0.1.1.15.2.1.3SECTION 830.40
     830.40 Use and discontinuation of a device identifier.
21:8.0.1.1.15.2.1.4SECTION 830.50
     830.50 Changes that require use of a new device identifier.
21:8.0.1.1.15.2.1.5SECTION 830.60
     830.60 Relabeling of a device that is required to bear a unique device identifier.
21:8.0.1.1.15.3SUBPART C
Subpart C - FDA Accreditation of an Issuing Agency
21:8.0.1.1.15.3.1.1SECTION 830.100
     830.100 FDA accreditation of an issuing agency.
21:8.0.1.1.15.3.1.2SECTION 830.110
     830.110 Application for accreditation as an issuing agency.
21:8.0.1.1.15.3.1.3SECTION 830.120
     830.120 Responsibilities of an FDA-accredited issuing agency.
21:8.0.1.1.15.3.1.4SECTION 830.130
     830.130 Suspension or revocation of the accreditation of an issuing agency.
21:8.0.1.1.15.4SUBPART D
Subpart D - FDA as an Issuing Agency
21:8.0.1.1.15.4.1.1SECTION 830.200
     830.200 When FDA will act as an issuing agency.
21:8.0.1.1.15.4.1.2SECTION 830.210
     830.210 Eligibility for use of FDA as an issuing agency.
21:8.0.1.1.15.4.1.3SECTION 830.220
     830.220 Termination of FDA service as an issuing agency.
21:8.0.1.1.15.5SUBPART E
Subpart E - Global Unique Device Identification Database
21:8.0.1.1.15.5.1.1SECTION 830.300
     830.300 Devices subject to device identification data submission requirements.
21:8.0.1.1.15.5.1.2SECTION 830.310
     830.310 Information required for unique device identification.
21:8.0.1.1.15.5.1.3SECTION 830.320
     830.320 Submission of unique device identification information.
21:8.0.1.1.15.5.1.4SECTION 830.330
     830.330 Times for submission of unique device identification information.
21:8.0.1.1.15.5.1.5SECTION 830.340
     830.340 Voluntary submission of ancillary device identification information.
21:8.0.1.1.15.5.1.6SECTION 830.350
     830.350 Correction of information submitted to the Global Unique Device Identification Database.
21:8.0.1.1.15.5.1.7SECTION 830.360
     830.360 Records to be maintained by the labeler.
21:8.0.1.1.16PART 860
PART 860 - MEDICAL DEVICE CLASSIFICATION PROCEDURES
21:8.0.1.1.16.1SUBPART A
Subpart A - General
21:8.0.1.1.16.1.1.1SECTION 860.1
     860.1 Scope.
21:8.0.1.1.16.1.1.2SECTION 860.3
     860.3 Definitions.
21:8.0.1.1.16.1.1.3SECTION 860.5
     860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification.
21:8.0.1.1.16.1.1.4SECTION 860.7
     860.7 Determination of safety and effectiveness.
21:8.0.1.1.16.1.1.5SECTION 860.10
     860.10 Implants and life-supporting or life-sustaining devices.
21:8.0.1.1.16.1.1.6SECTION 860.15
     860.15 Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.2SUBPART B
Subpart B - Classification
21:8.0.1.1.16.2.1.1SECTION 860.84
     860.84 Classification procedures for “preamendments devices.”
21:8.0.1.1.16.2.1.2SECTION 860.90
     860.90 Consultation with panels.
21:8.0.1.1.16.3SUBPART C
Subpart C - Reclassification
21:8.0.1.1.16.3.1.1SECTION 860.120
     860.120 General.
21:8.0.1.1.16.3.1.2SECTION 860.123
     860.123 Reclassification petition: Content and form.
21:8.0.1.1.16.3.1.3SECTION 860.125
     860.125 Consultation with panels.
21:8.0.1.1.16.3.1.4SECTION 860.130
     860.130 General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.3.1.5SECTION 860.132
     860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.3.1.6SECTION 860.133
     860.133 Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.3.1.7SECTION 860.134
     860.134 Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.3.1.8SECTION 860.136
     860.136 Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.17PART 861
PART 861 - PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
21:8.0.1.1.17.1SUBPART A
Subpart A - General
21:8.0.1.1.17.1.1.1SECTION 861.1
     861.1 Purpose and scope.
21:8.0.1.1.17.1.1.2SECTION 861.5
     861.5 Statement of policy.
21:8.0.1.1.17.1.1.3SECTION 861.7
     861.7 Contents of standards.
21:8.0.1.1.17.2SUBPART B
Subpart B - Procedures for Performance Standards Development and Publication
21:8.0.1.1.17.2.1.1SECTION 861.20
     861.20 Summary of standards development process.
21:8.0.1.1.17.2.1.2SECTION 861.24
     861.24 Existing standard as a proposed standard.
21:8.0.1.1.17.2.1.3SECTION 861.30
     861.30 Development of standards.
21:8.0.1.1.17.2.1.4SECTION 861.34
     861.34 Amendment or revocation of a standard.
21:8.0.1.1.17.2.1.5SECTION 861.36
     861.36 Effective dates.
21:8.0.1.1.17.2.1.6SECTION 861.38
     861.38 Standards advisory committees.
21:8.0.1.1.18PART 862
PART 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
21:8.0.1.1.18.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.18.1.1.1SECTION 862.1
     862.1 Scope.
21:8.0.1.1.18.1.1.2SECTION 862.2
     862.2 Regulation of calibrators.
21:8.0.1.1.18.1.1.3SECTION 862.3
     862.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.18.1.1.4SECTION 862.9
     862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.18.2SUBPART B
Subpart B - Clinical Chemistry Test Systems
21:8.0.1.1.18.2.1.1SECTION 862.1020
     862.1020 Acid phosphatase (total or prostatic) test system.
21:8.0.1.1.18.2.1.2SECTION 862.1025
     862.1025 Adrenocorticotropic hormone (ACTH) test system.
21:8.0.1.1.18.2.1.3SECTION 862.1030
     862.1030 Alanine amino transferase (ALT/SGPT) test system.
21:8.0.1.1.18.2.1.4SECTION 862.1035
     862.1035 Albumin test system.
21:8.0.1.1.18.2.1.5SECTION 862.1040
     862.1040 Aldolase test system.
21:8.0.1.1.18.2.1.6SECTION 862.1045
     862.1045 Aldosterone test system.
21:8.0.1.1.18.2.1.7SECTION 862.1050
     862.1050 Alkaline phosphatase or isoenzymes test system.
21:8.0.1.1.18.2.1.8SECTION 862.1055
     862.1055 Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
21:8.0.1.1.18.2.1.9SECTION 862.1060
     862.1060 Delta-aminolevulinic acid test system.
21:8.0.1.1.18.2.1.10SECTION 862.1065
     862.1065 Ammonia test system.
21:8.0.1.1.18.2.1.11SECTION 862.1070
     862.1070 Amylase test system.
21:8.0.1.1.18.2.1.12SECTION 862.1075
     862.1075 Androstenedione test system.
21:8.0.1.1.18.2.1.13SECTION 862.1080
     862.1080 Androsterone test system.
21:8.0.1.1.18.2.1.14SECTION 862.1085
     862.1085 Angiotensin I and renin test system.
21:8.0.1.1.18.2.1.15SECTION 862.1090
     862.1090 Angiotensin converting enzyme (A.C.E.) test system.
21:8.0.1.1.18.2.1.16SECTION 862.1095
     862.1095 Ascorbic acid test system.
21:8.0.1.1.18.2.1.17SECTION 862.1100
     862.1100 Aspartate amino transferase (AST/SGOT) test system.
21:8.0.1.1.18.2.1.18SECTION 862.1110
     862.1110 Bilirubin (total or direct) test system.
21:8.0.1.1.18.2.1.19SECTION 862.1113
     862.1113 Bilirubin (total and unbound) in the neonate test system.
21:8.0.1.1.18.2.1.20SECTION 862.1115
     862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system.
21:8.0.1.1.18.2.1.21SECTION 862.1117
     862.1117 B-type natriuretic peptide test system.
21:8.0.1.1.18.2.1.22SECTION 862.1118
     862.1118 Biotinidase test system.
21:8.0.1.1.18.2.1.23SECTION 862.1120
     862.1120 Blood gases (PCO2, PO2) and blood pH test system.
21:8.0.1.1.18.2.1.24SECTION 862.1130
     862.1130 Blood volume test system.
21:8.0.1.1.18.2.1.25SECTION 862.1135
     862.1135 C-peptides of proinsulin test system.
21:8.0.1.1.18.2.1.26SECTION 862.1140
     862.1140 Calcitonin test system.
21:8.0.1.1.18.2.1.27SECTION 862.1145
     862.1145 Calcium test system.
21:8.0.1.1.18.2.1.28SECTION 862.1150
     862.1150 Calibrator.
21:8.0.1.1.18.2.1.29SECTION 862.1155
     862.1155 Human chorionic gonadotropin (HCG) test system.
21:8.0.1.1.18.2.1.30SECTION 862.1160
     862.1160 Bicarbonate/carbon dioxide test system.
21:8.0.1.1.18.2.1.31SECTION 862.1163
     862.1163 Cardiac allograft gene expression profiling test system.
21:8.0.1.1.18.2.1.32SECTION 862.1165
     862.1165 Catecholamines (total) test system.
21:8.0.1.1.18.2.1.33SECTION 862.1170
     862.1170 Chloride test system.
21:8.0.1.1.18.2.1.34SECTION 862.1175
     862.1175 Cholesterol (total) test system.
21:8.0.1.1.18.2.1.35SECTION 862.1177
     862.1177 Cholylglycine test system.
21:8.0.1.1.18.2.1.36SECTION 862.1180
     862.1180 Chymotrypsin test system.
21:8.0.1.1.18.2.1.37SECTION 862.1185
     862.1185 Compound S (11-deoxycortisol) test system.
21:8.0.1.1.18.2.1.38SECTION 862.1187
     862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
21:8.0.1.1.18.2.1.39SECTION 862.1190
     862.1190 Copper test system.
21:8.0.1.1.18.2.1.40SECTION 862.1195
     862.1195 Corticoids test system.
21:8.0.1.1.18.2.1.41SECTION 862.1200
     862.1200 Corticosterone test system.
21:8.0.1.1.18.2.1.42SECTION 862.1205
     862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
21:8.0.1.1.18.2.1.43SECTION 862.1210
     862.1210 Creatine test system.
21:8.0.1.1.18.2.1.44SECTION 862.1215
     862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
21:8.0.1.1.18.2.1.45SECTION 862.1220
     862.1220 Acute kidney injury test system.
21:8.0.1.1.18.2.1.46SECTION 862.1225
     862.1225 Creatinine test system.
21:8.0.1.1.18.2.1.47SECTION 862.1230
     862.1230 Cyclic AMP test system.
21:8.0.1.1.18.2.1.48SECTION 862.1235
     862.1235 Cyclosporine test system.
21:8.0.1.1.18.2.1.49SECTION 862.1240
     862.1240 Cystine test system.
21:8.0.1.1.18.2.1.50SECTION 862.1245
     862.1245 Dehydroepiandrosterone (free and sulfate) test system.
21:8.0.1.1.18.2.1.51SECTION 862.1250
     862.1250 Desoxycorticosterone test system.
21:8.0.1.1.18.2.1.52SECTION 862.1255
     862.1255 2,3-Diphosphoglyceric acid test system.
21:8.0.1.1.18.2.1.53SECTION 862.1260
     862.1260 Estradiol test system.
21:8.0.1.1.18.2.1.54SECTION 862.1265
     862.1265 Estriol test system.
21:8.0.1.1.18.2.1.55SECTION 862.1270
     862.1270 Estrogens (total, in pregnancy) test system.
21:8.0.1.1.18.2.1.56SECTION 862.1275
     862.1275 Estrogens (total, nonpregnancy) test system.
21:8.0.1.1.18.2.1.57SECTION 862.1280
     862.1280 Estrone test system.
21:8.0.1.1.18.2.1.58SECTION 862.1285
     862.1285 Etiocholanolone test system.
21:8.0.1.1.18.2.1.59SECTION 862.1290
     862.1290 Fatty acids test system.
21:8.0.1.1.18.2.1.60SECTION 862.1295
     862.1295 Folic acid test system.
21:8.0.1.1.18.2.1.61SECTION 862.1300
     862.1300 Follicle-stimulating hormone test system.
21:8.0.1.1.18.2.1.62SECTION 862.1305
     862.1305 Formiminoglutamic acid (FIGLU) test system.
21:8.0.1.1.18.2.1.63SECTION 862.1310
     862.1310 Galactose test system.
21:8.0.1.1.18.2.1.64SECTION 862.1315
     862.1315 Galactose-1-phosphate uridyl transferase test system.
21:8.0.1.1.18.2.1.65SECTION 862.1320
     862.1320 Gastric acidity test system.
21:8.0.1.1.18.2.1.66SECTION 862.1325
     862.1325 Gastrin test system.
21:8.0.1.1.18.2.1.67SECTION 862.1330
     862.1330 Globulin test system.
21:8.0.1.1.18.2.1.68SECTION 862.1335
     862.1335 Glucagon test system.
21:8.0.1.1.18.2.1.69SECTION 862.1340
     862.1340 Urinary glucose (nonquantitative) test system.
21:8.0.1.1.18.2.1.70SECTION 862.1345
     862.1345 Glucose test system.
21:8.0.1.1.18.2.1.71SECTION 862.1350
     862.1350 Continuous glucose monitor secondary display.
21:8.0.1.1.18.2.1.72SECTION 862.1358
     862.1358 Insulin therapy adjustment device.
21:8.0.1.1.18.2.1.73SECTION 862.1360
     862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
21:8.0.1.1.18.2.1.74SECTION 862.1365
     862.1365 Glutathione test system.
21:8.0.1.1.18.2.1.75SECTION 862.1370
     862.1370 Human growth hormone test system.
21:8.0.1.1.18.2.1.76SECTION 862.1373
     862.1373 Hemoglobin A1c test system.
21:8.0.1.1.18.2.1.77SECTION 862.1375
     862.1375 Histidine test system.
21:8.0.1.1.18.2.1.78SECTION 862.1377
     862.1377 Urinary homocystine (nonquantitative) test system.
21:8.0.1.1.18.2.1.79SECTION 862.1380
     862.1380 Hydroxybutyric dehydrogenase test system.
21:8.0.1.1.18.2.1.80SECTION 862.1385
     862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
21:8.0.1.1.18.2.1.81SECTION 862.1390
     862.1390 5-Hydroxyindole acetic acid/serotonin test system.
21:8.0.1.1.18.2.1.82SECTION 862.1395
     862.1395 17-Hydroxyprogesterone test system.
21:8.0.1.1.18.2.1.83SECTION 862.1400
     862.1400 Hydroxyproline test system.
21:8.0.1.1.18.2.1.84SECTION 862.1405
     862.1405 Immunoreactive insulin test system.
21:8.0.1.1.18.2.1.85SECTION 862.1410
     862.1410 Iron (non-heme) test system.
21:8.0.1.1.18.2.1.86SECTION 862.1415
     862.1415 Iron-binding capacity test system.
21:8.0.1.1.18.2.1.87SECTION 862.1420
     862.1420 Isocitric dehydrogenase test system.
21:8.0.1.1.18.2.1.88SECTION 862.1430
     862.1430 17-Ketosteroids test system.
21:8.0.1.1.18.2.1.89SECTION 862.1435
     862.1435 Ketones (nonquantitative) test system.
21:8.0.1.1.18.2.1.90SECTION 862.1440
     862.1440 Lactate dehydrogenase test system.
21:8.0.1.1.18.2.1.91SECTION 862.1445
     862.1445 Lactate dehydrogenase isoenzymes test system.
21:8.0.1.1.18.2.1.92SECTION 862.1450
     862.1450 Lactic acid test system.
21:8.0.1.1.18.2.1.93SECTION 862.1455
     862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.
21:8.0.1.1.18.2.1.94SECTION 862.1460
     862.1460 Leucine aminopeptidase test system.
21:8.0.1.1.18.2.1.95SECTION 862.1465
     862.1465 Lipase test system.
21:8.0.1.1.18.2.1.96SECTION 862.1470
     862.1470 Lipid (total) test system.
21:8.0.1.1.18.2.1.97SECTION 862.1475
     862.1475 Lipoprotein test system.
21:8.0.1.1.18.2.1.98SECTION 862.1485
     862.1485 Luteinizing hormone test system.
21:8.0.1.1.18.2.1.99SECTION 862.1490
     862.1490 Lysozyme (muramidase) test system.
21:8.0.1.1.18.2.1.100SECTION 862.1495
     862.1495 Magnesium test system.
21:8.0.1.1.18.2.1.101SECTION 862.1500
     862.1500 Malic dehydrogenase test system.
21:8.0.1.1.18.2.1.102SECTION 862.1505
     862.1505 Mucopolysaccharides (nonquantitative) test system.
21:8.0.1.1.18.2.1.103SECTION 862.1509
     862.1509 Methylmalonic acid (nonquantitative) test system.
21:8.0.1.1.18.2.1.104SECTION 862.1510
     862.1510 Nitrite (nonquantitative) test system.
21:8.0.1.1.18.2.1.105SECTION 862.1515
     862.1515 Nitrogen (amino-nitrogen) test system.
21:8.0.1.1.18.2.1.106SECTION 862.1520
     862.1520 5′-Nucleotidase test system.
21:8.0.1.1.18.2.1.107SECTION 862.1530
     862.1530 Plasma oncometry test system.
21:8.0.1.1.18.2.1.108SECTION 862.1535
     862.1535 Ornithine carbamyl transferase test system.
21:8.0.1.1.18.2.1.109SECTION 862.1540
     862.1540 Osmolality test system.
21:8.0.1.1.18.2.1.110SECTION 862.1542
     862.1542 Oxalate test system.
21:8.0.1.1.18.2.1.111SECTION 862.1545
     862.1545 Parathyroid hormone test system.
21:8.0.1.1.18.2.1.112SECTION 862.1550
     862.1550 Urinary pH (nonquantitative) test system.
21:8.0.1.1.18.2.1.113SECTION 862.1555
     862.1555 Phenylalanine test system.
21:8.0.1.1.18.2.1.114SECTION 862.1560
     862.1560 Urinary phenylketones (nonquantitative) test system.
21:8.0.1.1.18.2.1.115SECTION 862.1565
     862.1565 6-Phosphogluconate dehydrogenase test system.
21:8.0.1.1.18.2.1.116SECTION 862.1570
     862.1570 Phosphohexose isomerase test system.
21:8.0.1.1.18.2.1.117SECTION 862.1575
     862.1575 Phospholipid test system.
21:8.0.1.1.18.2.1.118SECTION 862.1580
     862.1580 Phosphorus (inorganic) test system.
21:8.0.1.1.18.2.1.119SECTION 862.1585
     862.1585 Human placental lactogen test system.
21:8.0.1.1.18.2.1.120SECTION 862.1590
     862.1590 Porphobilinogen test system.
21:8.0.1.1.18.2.1.121SECTION 862.1595
     862.1595 Porphyrins test system.
21:8.0.1.1.18.2.1.122SECTION 862.1600
     862.1600 Potassium test system.
21:8.0.1.1.18.2.1.123SECTION 862.1605
     862.1605 Pregnanediol test system.
21:8.0.1.1.18.2.1.124SECTION 862.1610
     862.1610 Pregnanetriol test system.
21:8.0.1.1.18.2.1.125SECTION 862.1615
     862.1615 Pregnenolone test system.
21:8.0.1.1.18.2.1.126SECTION 862.1620
     862.1620 Progesterone test system.
21:8.0.1.1.18.2.1.127SECTION 862.1625
     862.1625 Prolactin (lactogen) test system.
21:8.0.1.1.18.2.1.128SECTION 862.1630
     862.1630 Protein (fractionation) test system.
21:8.0.1.1.18.2.1.129SECTION 862.1635
     862.1635 Total protein test system.
21:8.0.1.1.18.2.1.130SECTION 862.1640
     862.1640 Protein-bound iodine test system.
21:8.0.1.1.18.2.1.131SECTION 862.1645
     862.1645 Urinary protein or albumin (nonquantitative) test system.
21:8.0.1.1.18.2.1.132SECTION 862.1650
     862.1650 Pyruvate kinase test system.
21:8.0.1.1.18.2.1.133SECTION 862.1655
     862.1655 Pyruvic acid test system.
21:8.0.1.1.18.2.1.134SECTION 862.1660
     862.1660 Quality control material (assayed and unassayed).
21:8.0.1.1.18.2.1.135SECTION 862.1665
     862.1665 Sodium test system.
21:8.0.1.1.18.2.1.136SECTION 862.1670
     862.1670 Sorbitol dehydrogenase test system.
21:8.0.1.1.18.2.1.137SECTION 862.1675
     862.1675 Blood specimen collection device.
21:8.0.1.1.18.2.1.138SECTION 862.1678
     862.1678 Tacrolimus test system.
21:8.0.1.1.18.2.1.139SECTION 862.1680
     862.1680 Testosterone test system.
21:8.0.1.1.18.2.1.140SECTION 862.1685
     862.1685 Thyroxine-binding globulin test system.
21:8.0.1.1.18.2.1.141SECTION 862.1690
     862.1690 Thyroid stimulating hormone test system.
21:8.0.1.1.18.2.1.142SECTION 862.1695
     862.1695 Free thyroxine test system.
21:8.0.1.1.18.2.1.143SECTION 862.1700
     862.1700 Total thyroxine test system.
21:8.0.1.1.18.2.1.144SECTION 862.1705
     862.1705 Triglyceride test system.
21:8.0.1.1.18.2.1.145SECTION 862.1710
     862.1710 Total triiodothyronine test system.
21:8.0.1.1.18.2.1.146SECTION 862.1715
     862.1715 Triiodothyronine uptake test system.
21:8.0.1.1.18.2.1.147SECTION 862.1720
     862.1720 Triose phosphate isomerase test system.
21:8.0.1.1.18.2.1.148SECTION 862.1725
     862.1725 Trypsin test system.
21:8.0.1.1.18.2.1.149SECTION 862.1730
     862.1730 Free tyrosine test system.
21:8.0.1.1.18.2.1.150SECTION 862.1770
     862.1770 Urea nitrogen test system.
21:8.0.1.1.18.2.1.151SECTION 862.1775
     862.1775 Uric acid test system.
21:8.0.1.1.18.2.1.152SECTION 862.1780
     862.1780 Urinary calculi (stones) test system.
21:8.0.1.1.18.2.1.153SECTION 862.1785
     862.1785 Urinary urobilinogen (nonquantitative) test system.
21:8.0.1.1.18.2.1.154SECTION 862.1790
     862.1790 Uroporphyrin test system.
21:8.0.1.1.18.2.1.155SECTION 862.1795
     862.1795 Vanilmandelic acid test system.
21:8.0.1.1.18.2.1.156SECTION 862.1805
     862.1805 Vitamin A test system.
21:8.0.1.1.18.2.1.157SECTION 862.1810
     862.1810 Vitamin B12 test system.
21:8.0.1.1.18.2.1.158SECTION 862.1815
     862.1815 Vitamin E test system.
21:8.0.1.1.18.2.1.159SECTION 862.1820
     862.1820 Xylose test system.
21:8.0.1.1.18.2.1.160SECTION 862.1825
     862.1825 Vitamin D test system.
21:8.0.1.1.18.2.1.161SECTION 862.1840
     862.1840 Total 25-hydroxyvitamin D mass spectrometry test system.
21:8.0.1.1.18.3SUBPART C
Subpart C - Clinical Laboratory Instruments
21:8.0.1.1.18.3.1.1SECTION 862.2050
     862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
21:8.0.1.1.18.3.1.2SECTION 862.2100
     862.2100 Calculator/data processing module for clinical use.
21:8.0.1.1.18.3.1.3SECTION 862.2120
     862.2120 Continuous glucose monitor data management system.
21:8.0.1.1.18.3.1.4SECTION 862.2140
     862.2140 Centrifugal chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.5SECTION 862.2150
     862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.6SECTION 862.2160
     862.2160 Discrete photometric chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.7SECTION 862.2170
     862.2170 Micro chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.8SECTION 862.2230
     862.2230 Chromatographic separation material for clinical use.
21:8.0.1.1.18.3.1.9SECTION 862.2250
     862.2250 Gas liquid chromatography system for clinical use.
21:8.0.1.1.18.3.1.10SECTION 862.2260
     862.2260 High pressure liquid chromatography system for clinical use.
21:8.0.1.1.18.3.1.11SECTION 862.2265
     862.2265 High throughput genomic sequence analyzer for clinical use.
21:8.0.1.1.18.3.1.12SECTION 862.2270
     862.2270 Thin-layer chromatography system for clinical use.
21:8.0.1.1.18.3.1.13SECTION 862.2300
     862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
21:8.0.1.1.18.3.1.14SECTION 862.2310
     862.2310 Clinical sample concentrator.
21:8.0.1.1.18.3.1.15SECTION 862.2320
     862.2320 Beta or gamma counter for clinical use.
21:8.0.1.1.18.3.1.16SECTION 862.2400
     862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
21:8.0.1.1.18.3.1.17SECTION 862.2485
     862.2485 Electrophoresis apparatus for clinical use.
21:8.0.1.1.18.3.1.18SECTION 862.2500
     862.2500 Enzyme analyzer for clinical use.
21:8.0.1.1.18.3.1.19SECTION 862.2540
     862.2540 Flame emission photometer for clinical use.
21:8.0.1.1.18.3.1.20SECTION 862.2560
     862.2560 Fluorometer for clinical use.
21:8.0.1.1.18.3.1.21SECTION 862.2570
     862.2570 Instrumentation for clinical multiplex test systems.
21:8.0.1.1.18.3.1.22SECTION 862.2680
     862.2680 Microtitrator for clinical use.
21:8.0.1.1.18.3.1.23SECTION 862.2700
     862.2700 Nephelometer for clinical use.
21:8.0.1.1.18.3.1.24SECTION 862.2720
     862.2720 Plasma oncometer for clinical use.
21:8.0.1.1.18.3.1.25SECTION 862.2730
     862.2730 Osmometer for clinical use.
21:8.0.1.1.18.3.1.26SECTION 862.2750
     862.2750 Pipetting and diluting system for clinical use.
21:8.0.1.1.18.3.1.27SECTION 862.2800
     862.2800 Refractometer for clinical use.
21:8.0.1.1.18.3.1.28SECTION 862.2850
     862.2850 Atomic absorption spectrophotometer for clinical use.
21:8.0.1.1.18.3.1.29SECTION 862.2860
     862.2860 Mass spectrometer for clinical use.
21:8.0.1.1.18.3.1.30SECTION 862.2900
     862.2900 Automated urinalysis system.
21:8.0.1.1.18.3.1.31SECTION 862.2920
     862.2920 Plasma viscometer for clinical use.
21:8.0.1.1.18.4SUBPART D
Subpart D - Clinical Toxicology Test Systems
21:8.0.1.1.18.4.1.1SECTION 862.3030
     862.3030 Acetaminophen test system.
21:8.0.1.1.18.4.1.2SECTION 862.3035
     862.3035 Amikacin test system.
21:8.0.1.1.18.4.1.3SECTION 862.3040
     862.3040 Alcohol test system.
21:8.0.1.1.18.4.1.4SECTION 862.3050
     862.3050 Breath-alcohol test system.
21:8.0.1.1.18.4.1.5SECTION 862.3080
     862.3080 Breath nitric oxide test system.
21:8.0.1.1.18.4.1.6SECTION 862.3100
     862.3100 Amphetamine test system.
21:8.0.1.1.18.4.1.7SECTION 862.3110
     862.3110 Antimony test system.
21:8.0.1.1.18.4.1.8SECTION 862.3120
     862.3120 Arsenic test system.
21:8.0.1.1.18.4.1.9SECTION 862.3150
     862.3150 Barbiturate test system.
21:8.0.1.1.18.4.1.10SECTION 862.3170
     862.3170 Benzodiazepine test system.
21:8.0.1.1.18.4.1.11SECTION 862.3200
     862.3200 Clinical toxicology calibrator.
21:8.0.1.1.18.4.1.12SECTION 862.3220
     862.3220 Carbon monoxide test system.
21:8.0.1.1.18.4.1.13SECTION 862.3240
     862.3240 Cholinesterase test system.
21:8.0.1.1.18.4.1.14SECTION 862.3250
     862.3250 Cocaine and cocaine metabolite test system.
21:8.0.1.1.18.4.1.15SECTION 862.3270
     862.3270 Codeine test system.
21:8.0.1.1.18.4.1.16SECTION 862.3280
     862.3280 Clinical toxicology control material.
21:8.0.1.1.18.4.1.17SECTION 862.3300
     862.3300 Digitoxin test system.
21:8.0.1.1.18.4.1.18SECTION 862.3320
     862.3320 Digoxin test system.
21:8.0.1.1.18.4.1.19SECTION 862.3350
     862.3350 Diphenylhydantoin test system.
21:8.0.1.1.18.4.1.20SECTION 862.3360
     862.3360 Drug metabolizing enzyme genotyping system.
21:8.0.1.1.18.4.1.21SECTION 862.3380
     862.3380 Ethosuximide test system.
21:8.0.1.1.18.4.1.22SECTION 862.3450
     862.3450 Gentamicin test system.
21:8.0.1.1.18.4.1.23SECTION 862.3520
     862.3520 Kanamycin test system.
21:8.0.1.1.18.4.1.24SECTION 862.3550
     862.3550 Lead test system.
21:8.0.1.1.18.4.1.25SECTION 862.3555
     862.3555 Lidocaine test system.
21:8.0.1.1.18.4.1.26SECTION 862.3560
     862.3560 Lithium test system.
21:8.0.1.1.18.4.1.27SECTION 862.3580
     862.3580 Lysergic acid diethylamide (LSD) test system.
21:8.0.1.1.18.4.1.28SECTION 862.3590
     862.3590 Meprobamate test system.
21:8.0.1.1.18.4.1.29SECTION 862.3600
     862.3600 Mercury test system.
21:8.0.1.1.18.4.1.30SECTION 862.3610
     862.3610 Methamphetamine test system.
21:8.0.1.1.18.4.1.31SECTION 862.3620
     862.3620 Methadone test system.
21:8.0.1.1.18.4.1.32SECTION 862.3630
     862.3630 Methaqualone test system.
21:8.0.1.1.18.4.1.33SECTION 862.3640
     862.3640 Morphine test system.
21:8.0.1.1.18.4.1.34SECTION 862.3645
     862.3645 Neuroleptic drugs radioreceptor assay test system.
21:8.0.1.1.18.4.1.35SECTION 862.3650
     862.3650 Opiate test system.
21:8.0.1.1.18.4.1.36SECTION 862.3652
     862.3652 Organophosphate test system.
21:8.0.1.1.18.4.1.37SECTION 862.3660
     862.3660 Phenobarbital test system.
21:8.0.1.1.18.4.1.38SECTION 862.3670
     862.3670 Phenothiazine test system.
21:8.0.1.1.18.4.1.39SECTION 862.3680
     862.3680 Primidone test system.
21:8.0.1.1.18.4.1.40SECTION 862.3700
     862.3700 Propoxyphene test system.
21:8.0.1.1.18.4.1.41SECTION 862.3750
     862.3750 Quinine test system.
21:8.0.1.1.18.4.1.42SECTION 862.3800
     862.3800 Reagents for molecular diagnostic instrument test systems.
21:8.0.1.1.18.4.1.43SECTION 862.3830
     862.3830 Salicylate test system.
21:8.0.1.1.18.4.1.44SECTION 862.3840
     862.3840 Sirolimus test system.
21:8.0.1.1.18.4.1.45SECTION 862.3850
     862.3850 Sulfonamide test system.
21:8.0.1.1.18.4.1.46SECTION 862.3870
     862.3870 Cannabinoid test system.
21:8.0.1.1.18.4.1.47SECTION 862.3880
     862.3880 Theophylline test system.
21:8.0.1.1.18.4.1.48SECTION 862.3900
     862.3900 Tobramycin test system.
21:8.0.1.1.18.4.1.49SECTION 862.3910
     862.3910 Tricyclic antidepressant drugs test system.
21:8.0.1.1.18.4.1.50SECTION 862.3950
     862.3950 Vancomycin test system.
21:8.0.1.1.19PART 864
PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
21:8.0.1.1.19.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.19.1.1.1SECTION 864.1
     864.1 Scope.
21:8.0.1.1.19.1.1.2SECTION 864.3
     864.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.19.1.1.3SECTION 864.9
     864.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.19.2SUBPART B
Subpart B - Biological Stains
21:8.0.1.1.19.2.1.1SECTION 864.1850
     864.1850 Dye and chemical solution stains.
21:8.0.1.1.19.2.1.2SECTION 864.1860
     864.1860 Immunohistochemistry reagents and kits.
21:8.0.1.1.19.2.1.3SECTION 864.1865
     864.1865 Cervical intraepithelial neoplasia (CIN) test system.
21:8.0.1.1.19.2.1.4SECTION 864.1866
     864.1866 Lynch syndrome test systems.
21:8.0.1.1.19.2.1.5SECTION 864.1870
     864.1870 Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
21:8.0.1.1.19.3SUBPART C
Subpart C - Cell And Tissue Culture Products
21:8.0.1.1.19.3.1.1SECTION 864.2220
     864.2220 Synthetic cell and tissue culture media and components.
21:8.0.1.1.19.3.1.2SECTION 864.2240
     864.2240 Cell and tissue culture supplies and equipment.
21:8.0.1.1.19.3.1.3SECTION 864.2260
     864.2260 Chromosome culture kit.
21:8.0.1.1.19.3.1.4SECTION 864.2280
     864.2280 Cultured animal and human cells.
21:8.0.1.1.19.3.1.5SECTION 864.2360
     864.2360 Mycoplasma detection media and components.
21:8.0.1.1.19.3.1.6SECTION 864.2800
     864.2800 Animal and human sera.
21:8.0.1.1.19.3.1.7SECTION 864.2875
     864.2875 Balanced salt solutions or formulations.
21:8.0.1.1.19.4SUBPART D
Subpart D - Pathology Instrumentation and Accessories
21:8.0.1.1.19.4.1.1SECTION 864.3010
     864.3010 Tissue processing equipment.
21:8.0.1.1.19.4.1.2SECTION 864.3250
     864.3250 Specimen transport and storage container.
21:8.0.1.1.19.4.1.3SECTION 864.3260
     864.3260 OTC test sample collection systems for drugs of abuse testing.
21:8.0.1.1.19.4.1.4SECTION 864.3300
     864.3300 Cytocentrifuge.
21:8.0.1.1.19.4.1.5SECTION 864.3400
     864.3400 Device for sealing microsections.
21:8.0.1.1.19.4.1.6SECTION 864.3600
     864.3600 Microscopes and accessories.
21:8.0.1.1.19.4.1.7SECTION 864.3700
     864.3700 Whole slide imaging system.
21:8.0.1.1.19.4.1.8SECTION 864.3800
     864.3800 Automated slide stainer.
21:8.0.1.1.19.4.1.9SECTION 864.3875
     864.3875 Automated tissue processor.
21:8.0.1.1.19.5SUBPART E
Subpart E - Specimen Preparation Reagents
21:8.0.1.1.19.5.1.1SECTION 864.4010
     864.4010 General purpose reagent.
21:8.0.1.1.19.5.1.2SECTION 864.4020
     864.4020 Analyte specific reagents.
21:8.0.1.1.19.5.1.3SECTION 864.4400
     864.4400 Enzyme preparations.
21:8.0.1.1.19.6SUBPART F
Subpart F - Automated and Semi-Automated Hematology Devices
21:8.0.1.1.19.6.1.1SECTION 864.5200
     864.5200 Automated cell counter.
21:8.0.1.1.19.6.1.2SECTION 864.5220
     864.5220 Automated differential cell counter.
21:8.0.1.1.19.6.1.3SECTION 864.5240
     864.5240 Automated blood cell diluting apparatus.
21:8.0.1.1.19.6.1.4SECTION 864.5260
     864.5260 Automated cell-locating device.
21:8.0.1.1.19.6.1.5SECTION 864.5300
     864.5300 Red cell indices device.
21:8.0.1.1.19.6.1.6SECTION 864.5350
     864.5350 Microsedimentation centrifuge.
21:8.0.1.1.19.6.1.7SECTION 864.5400
     864.5400 Coagulation instrument.
21:8.0.1.1.19.6.1.8SECTION 864.5425
     864.5425 Multipurpose system for in vitro coagulation studies.
21:8.0.1.1.19.6.1.9SECTION 864.5600
     864.5600 Automated hematocrit instrument.
21:8.0.1.1.19.6.1.10SECTION 864.5620
     864.5620 Automated hemoglobin system.
21:8.0.1.1.19.6.1.11SECTION 864.5680
     864.5680 Automated heparin analyzer.
21:8.0.1.1.19.6.1.12SECTION 864.5700
     864.5700 Automated platelet aggregation system.
21:8.0.1.1.19.6.1.13SECTION 864.5800
     864.5800 Automated sedimentation rate device.
21:8.0.1.1.19.6.1.14SECTION 864.5850
     864.5850 Automated slide spinner.
21:8.0.1.1.19.6.1.15SECTION 864.5950
     864.5950 Blood volume measuring device.
21:8.0.1.1.19.7SUBPART G
Subpart G - Manual Hematology Devices
21:8.0.1.1.19.7.1.1SECTION 864.6100
     864.6100 Bleeding time device.
21:8.0.1.1.19.7.1.2SECTION 864.6150
     864.6150 Capillary blood collection tube.
21:8.0.1.1.19.7.1.3SECTION 864.6160
     864.6160 Manual blood cell counting device.
21:8.0.1.1.19.7.1.4SECTION 864.6400
     864.6400 Hematocrit measuring device.
21:8.0.1.1.19.7.1.5SECTION 864.6550
     864.6550 Occult blood test.
21:8.0.1.1.19.7.1.6SECTION 864.6600
     864.6600 Osmotic fragility test.
21:8.0.1.1.19.7.1.7SECTION 864.6650
     864.6650 Platelet adhesion test.
21:8.0.1.1.19.7.1.8SECTION 864.6675
     864.6675 Platelet aggregometer.
21:8.0.1.1.19.7.1.9SECTION 864.6700
     864.6700 Erythrocyte sedimentation rate test.
21:8.0.1.1.19.8SUBPART H
Subpart H - Hematology Kits and Packages
21:8.0.1.1.19.8.1.1SECTION 864.7010
     864.7010 Flow cytometric test system for hematopoietic neoplasms.
21:8.0.1.1.19.8.1.2SECTION 864.7040
     864.7040 Adenosine triphosphate release assay.
21:8.0.1.1.19.8.1.3SECTION 864.7060
     864.7060 Antithrombin III assay.
21:8.0.1.1.19.8.1.4SECTION 864.7100
     864.7100 Red blood cell enzyme assay.
21:8.0.1.1.19.8.1.5SECTION 864.7140
     864.7140 Activated whole blood clotting time tests.
21:8.0.1.1.19.8.1.6SECTION 864.7250
     864.7250 Erythropoietin assay.
21:8.0.1.1.19.8.1.7SECTION 864.7275
     864.7275 Euglobulin lysis time tests.
21:8.0.1.1.19.8.1.8SECTION 864.7280
     864.7280 Factor V Leiden DNA mutation detection systems.
21:8.0.1.1.19.8.1.9SECTION 864.7290
     864.7290 Factor deficiency test.
21:8.0.1.1.19.8.1.10SECTION 864.7300
     864.7300 Fibrin monomer paracoagulation test.
21:8.0.1.1.19.8.1.11SECTION 864.7320
     864.7320 Fibrinogen/fibrin degradation products assay.
21:8.0.1.1.19.8.1.12SECTION 864.7340
     864.7340 Fibrinogen determination system.
21:8.0.1.1.19.8.1.13SECTION 864.7360
     864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
21:8.0.1.1.19.8.1.14SECTION 864.7375
     864.7375 Glutathione reductase assay.
21:8.0.1.1.19.8.1.15SECTION 864.7400
     864.7400 Hemoglobin A2 assay.
21:8.0.1.1.19.8.1.16SECTION 864.7415
     864.7415 Abnormal hemoglobin assay.
21:8.0.1.1.19.8.1.17SECTION 864.7425
     864.7425 Carboxyhemoglobin assay.
21:8.0.1.1.19.8.1.18SECTION 864.7440
     864.7440 Electrophoretic hemoglobin analysis system.
21:8.0.1.1.19.8.1.19SECTION 864.7455
     864.7455 Fetal hemoglobin assay.
21:8.0.1.1.19.8.1.20SECTION 864.7470
     864.7470 Glycosylated hemoglobin assay.
21:8.0.1.1.19.8.1.21SECTION 864.7490
     864.7490 Sulfhemoglobin assay.
21:8.0.1.1.19.8.1.22SECTION 864.7500
     864.7500 Whole blood hemoglobin assays.
21:8.0.1.1.19.8.1.23SECTION 864.7525
     864.7525 Heparin assay.
21:8.0.1.1.19.8.1.24SECTION 864.7660
     864.7660 Leukocyte alkaline phosphatase test.
21:8.0.1.1.19.8.1.25SECTION 864.7675
     864.7675 Leukocyte peroxidase test.
21:8.0.1.1.19.8.1.26SECTION 864.7695
     864.7695 Platelet factor 4 radioimmunoassay.
21:8.0.1.1.19.8.1.27SECTION 864.7720
     864.7720 Prothrombin consumption test.
21:8.0.1.1.19.8.1.28SECTION 864.7735
     864.7735 Prothrombin-proconvertin test and thrombotest.
21:8.0.1.1.19.8.1.29SECTION 864.7750
     864.7750 Prothrombin time test.
21:8.0.1.1.19.8.1.30SECTION 864.7825
     864.7825 Sickle cell test.
21:8.0.1.1.19.8.1.31SECTION 864.7875
     864.7875 Thrombin time test.
21:8.0.1.1.19.8.1.32SECTION 864.7900
     864.7900 Thromboplastin generation test.
21:8.0.1.1.19.8.1.33SECTION 864.7925
     864.7925 Partial thromboplastin time tests.
21:8.0.1.1.19.9SUBPART I
Subpart I - Hematology Reagents
21:8.0.1.1.19.9.1.1SECTION 864.8100
     864.8100 Bothrops atrox reagent.
21:8.0.1.1.19.9.1.2SECTION 864.8150
     864.8150 Calibrator for cell indices.
21:8.0.1.1.19.9.1.3SECTION 864.8165
     864.8165 Calibrator for hemoglobin or hematocrit measurement.
21:8.0.1.1.19.9.1.4SECTION 864.8175
     864.8175 Calibrator for platelet counting.
21:8.0.1.1.19.9.1.5SECTION 864.8185
     864.8185 Calibrator for red cell and white cell counting.
21:8.0.1.1.19.9.1.6SECTION 864.8200
     864.8200 Blood cell diluent.
21:8.0.1.1.19.9.1.7SECTION 864.8500
     864.8500 Lymphocyte separation medium.
21:8.0.1.1.19.9.1.8SECTION 864.8540
     864.8540 Red cell lysing reagent.
21:8.0.1.1.19.9.1.9SECTION 864.8625
     864.8625 Hematology quality control mixture.
21:8.0.1.1.19.9.1.10SECTION 864.8950
     864.8950 Russell viper venom reagent.
21:8.0.1.1.19.10SUBPART J
Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products
21:8.0.1.1.19.10.1.1SECTION 864.9050
     864.9050 Blood bank supplies.
21:8.0.1.1.19.10.1.2SECTION 864.9100
     864.9100 Empty container for the collection and processing of blood and blood components.
21:8.0.1.1.19.10.1.3SECTION 864.9125
     864.9125 Vacuum-assisted blood collection system.
21:8.0.1.1.19.10.1.4SECTION 864.9145
     864.9145 Processing system for frozen blood.
21:8.0.1.1.19.10.1.5SECTION 864.9160
     864.9160 Blood group substances of nonhuman origin for in vitro diagnostic use.
21:8.0.1.1.19.10.1.6SECTION 864.9165
     864.9165 Blood establishment computer software and accessories.
21:8.0.1.1.19.10.1.7SECTION 864.9175
     864.9175 Automated blood grouping and antibody test system.
21:8.0.1.1.19.10.1.8SECTION 864.9185
     864.9185 Blood grouping view box.
21:8.0.1.1.19.10.1.9SECTION 864.9195
     864.9195 Blood mixing devices and blood weighing devices.
21:8.0.1.1.19.10.1.10SECTION 864.9205
     864.9205 Blood and plasma warming device.
21:8.0.1.1.19.10.1.11SECTION 864.9225
     864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use.
21:8.0.1.1.19.10.1.12SECTION 864.9245
     864.9245 Automated blood cell separator.
21:8.0.1.1.19.10.1.13SECTION 864.9275
     864.9275 Blood bank centrifuge for in vitro diagnostic use.
21:8.0.1.1.19.10.1.14SECTION 864.9285
     864.9285 Automated cell-washing centrifuge for immuno-hematology.
21:8.0.1.1.19.10.1.15SECTION 864.9300
     864.9300 Automated Coombs test systems.
21:8.0.1.1.19.10.1.16SECTION 864.9320
     864.9320 Copper sulfate solution for specific gravity determinations.
21:8.0.1.1.19.10.1.17SECTION 864.9400
     864.9400 Stabilized enzyme solution.
21:8.0.1.1.19.10.1.18SECTION 864.9550
     864.9550 Lectins and protectins.
21:8.0.1.1.19.10.1.19SECTION 864.9575
     864.9575 Environmental chamber for storage of platelet concentrate.
21:8.0.1.1.19.10.1.20SECTION 864.9600
     864.9600 Potentiating media for in vitro diagnostic use.
21:8.0.1.1.19.10.1.21SECTION 864.9650
     864.9650 Quality control kit for blood banking reagents.
21:8.0.1.1.19.10.1.22SECTION 864.9700
     864.9700 Blood storage refrigerator and blood storage freezer.
21:8.0.1.1.19.10.1.23SECTION 864.9750
     864.9750 Heat-sealing device.
21:8.0.1.1.19.10.1.24SECTION 864.9875
     864.9875 Transfer set.
21:8.0.1.1.19.11SUBPART K
Subpart K - Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
21:8.0.1.1.19.11.1.1SECTION 864.9900
     864.9900 Cord blood processing system and storage container.
21:8.0.1.1.20PART 866
PART 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES
21:8.0.1.1.20.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.20.1.1.1SECTION 866.1
     866.1 Scope.
21:8.0.1.1.20.1.1.2SECTION 866.3
     866.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.20.1.1.3SECTION 866.9
     866.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.20.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.20.2.1.1SECTION 866.1620
     866.1620 Antimicrobial susceptibility test disc.
21:8.0.1.1.20.2.1.2SECTION 866.1640
     866.1640 Antimicrobial susceptibility test powder.
21:8.0.1.1.20.2.1.3SECTION 866.1645
     866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
21:8.0.1.1.20.2.1.4SECTION 866.1700
     866.1700 Culture medium for antimicrobial susceptibility tests.
21:8.0.1.1.20.3SUBPART C
Subpart C - Microbiology Devices
21:8.0.1.1.20.3.1.1SECTION 866.2050
     866.2050 Staphylococcal typing bacteriophage.
21:8.0.1.1.20.3.1.2SECTION 866.2120
     866.2120 Anaerobic chamber.
21:8.0.1.1.20.3.1.3SECTION 866.2160
     866.2160 Coagulase plasma.
21:8.0.1.1.20.3.1.4SECTION 866.2170
     866.2170 Automated colony counter.
21:8.0.1.1.20.3.1.5SECTION 866.2180
     866.2180 Manual colony counter.
21:8.0.1.1.20.3.1.6SECTION 866.2190
     866.2190 Automated image assessment system for microbial colonies on solid culture media.
21:8.0.1.1.20.3.1.7SECTION 866.2300
     866.2300 Multipurpose culture medium.
21:8.0.1.1.20.3.1.8SECTION 866.2320
     866.2320 Differential culture medium.
21:8.0.1.1.20.3.1.9SECTION 866.2330
     866.2330 Enriched culture medium.
21:8.0.1.1.20.3.1.10SECTION 866.2350
     866.2350 Microbiological assay culture medium.
21:8.0.1.1.20.3.1.11SECTION 866.2360
     866.2360 Selective culture medium.
21:8.0.1.1.20.3.1.12SECTION 866.2390
     866.2390 Transport culture medium.
21:8.0.1.1.20.3.1.13SECTION 866.2410
     866.2410 Culture medium for pathogenic Neisseria spp.
21:8.0.1.1.20.3.1.14SECTION 866.2420
     866.2420 Oxidase screening test for gonorrhea.
21:8.0.1.1.20.3.1.15SECTION 866.2440
     866.2440 Automated medium dispensing and stacking device.
21:8.0.1.1.20.3.1.16SECTION 866.2450
     866.2450 Supplement for culture media.
21:8.0.1.1.20.3.1.17SECTION 866.2480
     866.2480 Quality control kit for culture media.
21:8.0.1.1.20.3.1.18SECTION 866.2500
     866.2500 Microtiter diluting and dispensing device.
21:8.0.1.1.20.3.1.19SECTION 866.2540
     866.2540 Microbiological incubator.
21:8.0.1.1.20.3.1.20SECTION 866.2560
     866.2560 Microbial growth monitor.
21:8.0.1.1.20.3.1.21SECTION 866.2580
     866.2580 Gas-generating device.
21:8.0.1.1.20.3.1.22SECTION 866.2600
     866.2600 Wood's fluorescent lamp.
21:8.0.1.1.20.3.1.23SECTION 866.2660
     866.2660 Microorganism differentiation and identification device.
21:8.0.1.1.20.3.1.24SECTION 866.2680
     866.2680 Streptococcus spp. nucleic acid-based assay.
21:8.0.1.1.20.3.1.25SECTION 866.2850
     866.2850 Automated zone reader.
21:8.0.1.1.20.3.1.26SECTION 866.2900
     866.2900 Microbiological specimen collection and transport device.
21:8.0.1.1.20.4SUBPART D
Subpart D - Serological Reagents
21:8.0.1.1.20.4.1.1SECTION 866.3010
     866.3010 Acinetobacter calcoaceticus serological reagents.
21:8.0.1.1.20.4.1.2SECTION 866.3020
     866.3020 Adenovirus serological reagents.
21:8.0.1.1.20.4.1.3SECTION 866.3035
     866.3035 Arizona spp. serological reagents.
21:8.0.1.1.20.4.1.4SECTION 866.3040
     866.3040 Aspergillus spp. serological reagents.
21:8.0.1.1.20.4.1.5SECTION 866.3045
     866.3045 In vitro diagnostic device for Bacillus spp. detection.
21:8.0.1.1.20.4.1.6SECTION 866.3050
     866.3050 Beta-glucan serological assays.
21:8.0.1.1.20.4.1.7SECTION 866.3060
     866.3060 Blastomyces dermatitidis serological reagents.
21:8.0.1.1.20.4.1.8SECTION 866.3065
     866.3065 Bordetella spp. serological reagents.
21:8.0.1.1.20.4.1.9SECTION 866.3085
     866.3085 Brucella spp. serological reagents.
21:8.0.1.1.20.4.1.10SECTION 866.3110
     866.3110 Campylobacter fetus serological reagents.
21:8.0.1.1.20.4.1.11SECTION 866.3120
     866.3120 Chlamydia serological reagents.
21:8.0.1.1.20.4.1.12SECTION 866.3125
     866.3125 Citrobacter spp. serological reagents.
21:8.0.1.1.20.4.1.13SECTION 866.3130
     866.3130 Clostridium difficile toxin gene amplification assay.
21:8.0.1.1.20.4.1.14SECTION 866.3135
     866.3135 Coccidioides immitis serological reagents.
21:8.0.1.1.20.4.1.15SECTION 866.3140
     866.3140 Corynebacterium spp. serological reagents.
21:8.0.1.1.20.4.1.16SECTION 866.3145
     866.3145 Coxsackievirus serological reagents.
21:8.0.1.1.20.4.1.17SECTION 866.3165
     866.3165 Cryptococcus neoformans serological reagents.
21:8.0.1.1.20.4.1.18SECTION 866.3175
     866.3175 Cytomegalovirus serological reagents.
21:8.0.1.1.20.4.1.19SECTION 866.3200
     866.3200 Echinococcus spp. serological reagents.
21:8.0.1.1.20.4.1.20SECTION 866.3205
     866.3205 Echovirus serological reagents.
21:8.0.1.1.20.4.1.21SECTION 866.3210
     866.3210 Endotoxin assay.
21:8.0.1.1.20.4.1.22SECTION 866.3215
     866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
21:8.0.1.1.20.4.1.23SECTION 866.3220
     866.3220 Entamoeba histolytica serological reagents.
21:8.0.1.1.20.4.1.24SECTION 866.3225
     866.3225 Enterovirus nucleic acid assay.
21:8.0.1.1.20.4.1.25SECTION 866.3235
     866.3235 Epstein-Barr virus serological reagents.
21:8.0.1.1.20.4.1.26SECTION 866.3240
     866.3240 Equine encephalomyelitis virus serological reagents.
21:8.0.1.1.20.4.1.27SECTION 866.3250
     866.3250 Erysipelothrix rhusiopathiae serological reagents.
21:8.0.1.1.20.4.1.28SECTION 866.3255
     866.3255 Escherichia coli serological reagents.
21:8.0.1.1.20.4.1.29SECTION 866.3270
     866.3270 Flavobacterium spp. serological reagents.
21:8.0.1.1.20.4.1.30SECTION 866.3280
     866.3280 Francisella tularensis serological reagents.
21:8.0.1.1.20.4.1.31SECTION 866.3290
     866.3290 Gonococcal antibody test (GAT).
21:8.0.1.1.20.4.1.32SECTION 866.3300
     866.3300 Haemophilus spp. serological reagents.
21:8.0.1.1.20.4.1.33SECTION 866.3305
     866.3305 Herpes simplex virus serological assays.
21:8.0.1.1.20.4.1.34SECTION 866.3309
     866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
21:8.0.1.1.20.4.1.35SECTION 866.3310
     866.3310 Hepatitis A virus (HAV) serological assays.
21:8.0.1.1.20.4.1.36SECTION 866.3320
     866.3320 Histoplasma capsulatum serological reagents.
21:8.0.1.1.20.4.1.37SECTION 866.3328
     866.3328 Influenza virus antigen detection test system.
21:8.0.1.1.20.4.1.38SECTION 866.3330
     866.3330 Influenza virus serological reagents.
21:8.0.1.1.20.4.1.39SECTION 866.3332
     866.3332 Reagents for detection of specific novel influenza A viruses.
21:8.0.1.1.20.4.1.40SECTION 866.3336
     866.3336 John Cunningham Virus serological reagents.
21:8.0.1.1.20.4.1.41SECTION 866.3340
     866.3340 Klebsiella spp. serological reagents.
21:8.0.1.1.20.4.1.42SECTION 866.3350
     866.3350 Leptospira spp. serological reagents.
21:8.0.1.1.20.4.1.43SECTION 866.3355
     866.3355 Listeria spp. serological reagents.
21:8.0.1.1.20.4.1.44SECTION 866.3360
     866.3360 Lymphocytic choriomeningitis virus serological reagents.
21:8.0.1.1.20.4.1.45SECTION 866.3361
     866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.
21:8.0.1.1.20.4.1.46SECTION 866.3365
     866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
21:8.0.1.1.20.4.1.47SECTION 866.3370
     866.3370 Mycobacterium tuberculosis immunofluorescent reagents.
21:8.0.1.1.20.4.1.48SECTION 866.3372
     866.3372 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
21:8.0.1.1.20.4.1.49SECTION 866.3373
     866.3373 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens.
21:8.0.1.1.20.4.1.50SECTION 866.3375
     866.3375 Mycoplasma spp. serological reagents.
21:8.0.1.1.20.4.1.51SECTION 866.3380
     866.3380 Mumps virus serological reagents.
21:8.0.1.1.20.4.1.52SECTION 866.3390
     866.3390 Neisseria spp. direct serological test reagents.
21:8.0.1.1.20.4.1.53SECTION 866.3395
     866.3395 Norovirus serological reagents.
21:8.0.1.1.20.4.1.54SECTION 866.3400
     866.3400 Parainfluenza virus serological reagents.
21:8.0.1.1.20.4.1.55SECTION 866.3402
     866.3402 Plasmodium species antigen detection assays.
21:8.0.1.1.20.4.1.56SECTION 866.3405
     866.3405 Poliovirus serological reagents.
21:8.0.1.1.20.4.1.57SECTION 866.3410
     866.3410 Proteus spp. (Weil-Felix) serological reagents.
21:8.0.1.1.20.4.1.58SECTION 866.3415
     866.3415 Pseudomonas spp. serological reagents.
21:8.0.1.1.20.4.1.59SECTION 866.3460
     866.3460 Rabiesvirus immunofluorescent reagents.
21:8.0.1.1.20.4.1.60SECTION 866.3470
     866.3470 Reovirus serological reagents.
21:8.0.1.1.20.4.1.61SECTION 866.3480
     866.3480 Respiratory syncytial virus serological reagents.
21:8.0.1.1.20.4.1.62SECTION 866.3490
     866.3490 Rhinovirus serological reagents.
21:8.0.1.1.20.4.1.63SECTION 866.3500
     866.3500 Rickettsia serological reagents.
21:8.0.1.1.20.4.1.64SECTION 866.3510
     866.3510 Rubella virus serological reagents.
21:8.0.1.1.20.4.1.65SECTION 866.3520
     866.3520 Rubeola (measles) virus serological reagents.
21:8.0.1.1.20.4.1.66SECTION 866.3550
     866.3550 Salmonella spp. serological reagents.
21:8.0.1.1.20.4.1.67SECTION 866.3600
     866.3600 Schistosoma spp. serological reagents.
21:8.0.1.1.20.4.1.68SECTION 866.3630
     866.3630 Serratia spp. serological reagents.
21:8.0.1.1.20.4.1.69SECTION 866.3660
     866.3660 Shigella spp. serological reagents.
21:8.0.1.1.20.4.1.70SECTION 866.3680
     866.3680 Sporothrix schenckii serological reagents.
21:8.0.1.1.20.4.1.71SECTION 866.3700
     866.3700 Staphylococcus aureus serological reagents.
21:8.0.1.1.20.4.1.72SECTION 866.3720
     866.3720 Streptococcus spp. exoenzyme reagents.
21:8.0.1.1.20.4.1.73SECTION 866.3740
     866.3740 Streptococcus spp. serological reagents.
21:8.0.1.1.20.4.1.74SECTION 866.3780
     866.3780 Toxoplasma gondii serological reagents.
21:8.0.1.1.20.4.1.75SECTION 866.3820
     866.3820 Treponema pallidum nontreponemal test reagents.
21:8.0.1.1.20.4.1.76SECTION 866.3830
     866.3830 Treponema pallidum treponemal test reagents.
21:8.0.1.1.20.4.1.77SECTION 866.3850
     866.3850 Trichinella spiralis serological reagents.
21:8.0.1.1.20.4.1.78SECTION 866.3860
     866.3860 Trichomonas vaginalis nucleic acid assay.
21:8.0.1.1.20.4.1.79SECTION 866.3870
     866.3870 Trypanosoma spp. serological reagents.
21:8.0.1.1.20.4.1.80SECTION 866.3900
     866.3900 Varicella-zoster virus serological reagents.
21:8.0.1.1.20.4.1.81SECTION 866.3920
     866.3920 Assayed quality control material for clinical microbiology assays.
21:8.0.1.1.20.4.1.82SECTION 866.3930
     866.3930 Vibrio cholerae serological reagents.
21:8.0.1.1.20.4.1.83SECTION 866.3940
     866.3940 West Nile virus serological reagents.
21:8.0.1.1.20.4.1.84SECTION 866.3945
     866.3945 Dengue virus serological reagents.
21:8.0.1.1.20.4.1.85SECTION 866.3946
     866.3946 Dengue virus nucleic acid amplification test reagents.
21:8.0.1.1.20.4.1.86SECTION 866.3950
     866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
21:8.0.1.1.20.4.1.87SECTION 866.3955
     866.3955 Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.
21:8.0.1.1.20.4.1.88SECTION 866.3960
     866.3960 Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
21:8.0.1.1.20.4.1.89SECTION 866.3970
     866.3970 Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
21:8.0.1.1.20.4.1.90SECTION 866.3980
     866.3980 Respiratory viral panel multiplex nucleic acid assay.
21:8.0.1.1.20.4.1.91SECTION 866.3985
     866.3985 Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
21:8.0.1.1.20.4.1.92SECTION 866.3990
     866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
21:8.0.1.1.20.5SUBPART E
Subpart E - Immunology Laboratory Equipment and Reagents
21:8.0.1.1.20.5.1.1SECTION 866.4070
     866.4070 RNA Preanalytical Systems.
21:8.0.1.1.20.5.1.2SECTION 866.4100
     866.4100 Complement reagent.
21:8.0.1.1.20.5.1.3SECTION 866.4500
     866.4500 Immunoelectrophoresis equipment.
21:8.0.1.1.20.5.1.4SECTION 866.4520
     866.4520 Immunofluorometer equipment.
21:8.0.1.1.20.5.1.5SECTION 866.4540
     866.4540 Immunonephelometer equipment.
21:8.0.1.1.20.5.1.6SECTION 866.4600
     866.4600 Ouchterlony agar plate.
21:8.0.1.1.20.5.1.7SECTION 866.4700
     866.4700 Automated fluorescence in situ hybridization (FISH) enumeration systems.
21:8.0.1.1.20.5.1.8SECTION 866.4750
     866.4750 Automated indirect immunofluorescence microscope and software-assisted system.
21:8.0.1.1.20.5.1.9SECTION 866.4800
     866.4800 Radial immunodiffusion plate.
21:8.0.1.1.20.5.1.10SECTION 866.4830
     866.4830 Rocket immunoelectrophoresis equipment.
21:8.0.1.1.20.5.1.11SECTION 866.4900
     866.4900 Support gel.
21:8.0.1.1.20.6SUBPART F
Subpart F - Immunological Test Systems
21:8.0.1.1.20.6.1.1SECTION 866.5040
     866.5040 Albumin immunological test system.
21:8.0.1.1.20.6.1.2SECTION 866.5060
     866.5060 Prealbumin immunological test system.
21:8.0.1.1.20.6.1.3SECTION 866.5065
     866.5065 Human allotypic marker immunological test system.
21:8.0.1.1.20.6.1.4SECTION 866.5080
     866.5080 Alpha-1-antichymotrypsin immunological test system.
21:8.0.1.1.20.6.1.5SECTION 866.5090
     866.5090 Antimitochondrial antibody immunological test system.
21:8.0.1.1.20.6.1.6SECTION 866.5100
     866.5100 Antinuclear antibody immunological test system.
21:8.0.1.1.20.6.1.7SECTION 866.5110
     866.5110 Antiparietal antibody immunological test system.
21:8.0.1.1.20.6.1.8SECTION 866.5120
     866.5120 Antismooth muscle antibody immunological test system.
21:8.0.1.1.20.6.1.9SECTION 866.5130
     866.5130 Alpha-1-antitrypsin immunological test system.
21:8.0.1.1.20.6.1.10SECTION 866.5150
     866.5150 Bence-Jones proteins immunological test system.
21:8.0.1.1.20.6.1.11SECTION 866.5160
     866.5160 Beta-globulin immunological test system.
21:8.0.1.1.20.6.1.12SECTION 866.5170
     866.5170 Breast milk immunological test system.
21:8.0.1.1.20.6.1.13SECTION 866.5180
     866.5180 Fecal calprotectin immunological test system.
21:8.0.1.1.20.6.1.14SECTION 866.5200
     866.5200 Carbonic anhydrase B and C immunological test system.
21:8.0.1.1.20.6.1.15SECTION 866.5210
     866.5210 Ceruloplasmin immunological test system.
21:8.0.1.1.20.6.1.16SECTION 866.5220
     866.5220 Cohn fraction II immunological test system.
21:8.0.1.1.20.6.1.17SECTION 866.5230
     866.5230 Colostrum immunological test system.
21:8.0.1.1.20.6.1.18SECTION 866.5240
     866.5240 Complement components immunological test system.
21:8.0.1.1.20.6.1.19SECTION 866.5250
     866.5250 Complement C1 inhibitor (inactivator) immunological test system.
21:8.0.1.1.20.6.1.20SECTION 866.5260
     866.5260 Complement C3b inactivator immunological test system.
21:8.0.1.1.20.6.1.21SECTION 866.5270
     866.5270 C-reactive protein immunological test system.
21:8.0.1.1.20.6.1.22SECTION 866.5320
     866.5320 Properdin factor B immunological test system.
21:8.0.1.1.20.6.1.23SECTION 866.5330
     866.5330 Factor XIII, A, S, immunological test system.
21:8.0.1.1.20.6.1.24SECTION 866.5340
     866.5340 Ferritin immunological test system.
21:8.0.1.1.20.6.1.25SECTION 866.5350
     866.5350 Fibrinopeptide A immunological test system.
21:8.0.1.1.20.6.1.26SECTION 866.5360
     866.5360 Cohn fraction IV immunological test system.
21:8.0.1.1.20.6.1.27SECTION 866.5370
     866.5370 Cohn fraction V immunological test system.
21:8.0.1.1.20.6.1.28SECTION 866.5380
     866.5380 Free secretory component immunological test system.
21:8.0.1.1.20.6.1.29SECTION 866.5400
     866.5400 Alpha-globulin immunological test system.
21:8.0.1.1.20.6.1.30SECTION 866.5420
     866.5420 Alpha-1-glycoproteins immunological test system.
21:8.0.1.1.20.6.1.31SECTION 866.5425
     866.5425 Alpha-2-glycoproteins immunological test system.
21:8.0.1.1.20.6.1.32SECTION 866.5430
     866.5430 Beta-2-glycoprotein I immunological test system.
21:8.0.1.1.20.6.1.33SECTION 866.5440
     866.5440 Beta-2-glycoprotein III immunological test system.
21:8.0.1.1.20.6.1.34SECTION 866.5460
     866.5460 Haptoglobin immunological test system.
21:8.0.1.1.20.6.1.35SECTION 866.5470
     866.5470 Hemoglobin immunological test system.
21:8.0.1.1.20.6.1.36SECTION 866.5490
     866.5490 Hemopexin immunological test system.
21:8.0.1.1.20.6.1.37SECTION 866.5500
     866.5500 Hypersensitivity pneumonitis immunological test system.
21:8.0.1.1.20.6.1.38SECTION 866.5510
     866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
21:8.0.1.1.20.6.1.39SECTION 866.5520
     866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
21:8.0.1.1.20.6.1.40SECTION 866.5530
     866.5530 Immunoglobulin G (Fc fragment specific) immunological test system.
21:8.0.1.1.20.6.1.41SECTION 866.5540
     866.5540 Immunoglobulin G (Fd fragment specific) immunological test system.
21:8.0.1.1.20.6.1.42SECTION 866.5550
     866.5550 Immunoglobulin (light chain specific) immunological test system.
21:8.0.1.1.20.6.1.43SECTION 866.5560
     866.5560 Lactic dehydrogenase immunological test system.
21:8.0.1.1.20.6.1.44SECTION 866.5570
     866.5570 Lactoferrin immunological test system.
21:8.0.1.1.20.6.1.45SECTION 866.5580
     866.5580 Alpha-1-lipoprotein immunological test system.
21:8.0.1.1.20.6.1.46SECTION 866.5590
     866.5590 Lipoprotein X immunological test system.
21:8.0.1.1.20.6.1.47SECTION 866.5600
     866.5600 Low-density lipoprotein immunological test system.
21:8.0.1.1.20.6.1.48SECTION 866.5620
     866.5620 Alpha-2-macroglobulin immunological test system.
21:8.0.1.1.20.6.1.49SECTION 866.5630
     866.5630 Beta-2-microglobulin immunological test system.
21:8.0.1.1.20.6.1.50SECTION 866.5640
     866.5640 Infectious mononucleosis immunological test system.
21:8.0.1.1.20.6.1.51SECTION 866.5660
     866.5660 Multiple autoantibodies immunological test system.
21:8.0.1.1.20.6.1.52SECTION 866.5665
     866.5665 Aquaporin-4 autoantibody immunological test system.
21:8.0.1.1.20.6.1.53SECTION 866.5670
     866.5670 Zinc transporter 8 autoantibody immunological test system.
21:8.0.1.1.20.6.1.54SECTION 866.5680
     866.5680 Myoglobin immunological test system.
21:8.0.1.1.20.6.1.55SECTION 866.5700
     866.5700 Whole human plasma or serum immunological test system.
21:8.0.1.1.20.6.1.56SECTION 866.5715
     866.5715 Plasminogen immunological test system.
21:8.0.1.1.20.6.1.57SECTION 866.5735
     866.5735 Prothrombin immunological test system.
21:8.0.1.1.20.6.1.58SECTION 866.5750
     866.5750 Radioallergosorbent (RAST) immunological test system.
21:8.0.1.1.20.6.1.59SECTION 866.5760
     866.5760 Tryptase test system.
21:8.0.1.1.20.6.1.60SECTION 866.5765
     866.5765 Retinol-binding protein immunological test system.
21:8.0.1.1.20.6.1.61SECTION 866.5775
     866.5775 Rheumatoid factor immunological test system.
21:8.0.1.1.20.6.1.62SECTION 866.5785
     866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
21:8.0.1.1.20.6.1.63SECTION 866.5800
     866.5800 Seminal fluid (sperm) immunological test system.
21:8.0.1.1.20.6.1.64SECTION 866.5820
     866.5820 Systemic lupus erythematosus immunological test system.
21:8.0.1.1.20.6.1.65SECTION 866.5830
     866.5830 Brain trauma assessment test.
21:8.0.1.1.20.6.1.66SECTION 866.5860
     866.5860 Total spinal fluid immunological test system.
21:8.0.1.1.20.6.1.67SECTION 866.5870
     866.5870 Thyroid autoantibody immunological test system.
21:8.0.1.1.20.6.1.68SECTION 866.5880
     866.5880 Transferrin immunological test system.
21:8.0.1.1.20.6.1.69SECTION 866.5890
     866.5890 Inter-alpha trypsin inhibitor immunological test system.
21:8.0.1.1.20.6.1.70SECTION 866.5900
     866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
21:8.0.1.1.20.6.1.71SECTION 866.5910
     866.5910 Quality control material for cystic fibrosis nucleic acid assays.
21:8.0.1.1.20.6.1.72SECTION 866.5930
     866.5930 Newborn screening test for severe combined immunodeficiency disorder (SCID).
21:8.0.1.1.20.6.1.73SECTION 866.5940
     866.5940 Autosomal recessive carrier screening gene mutation detection system.
21:8.0.1.1.20.6.1.74SECTION 866.5950
     866.5950 Genetic health risk assessment system.
21:8.0.1.1.20.7SUBPART G
Subpart G - Tumor Associated Antigen immunological Test Systems
21:8.0.1.1.20.7.1.1SECTION 866.6010
     866.6010 Tumor-associated antigen immunological test system.
21:8.0.1.1.20.7.1.2SECTION 866.6020
     866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
21:8.0.1.1.20.7.1.3SECTION 866.6030
     866.6030 AFP-L3% immunological test system.
21:8.0.1.1.20.7.1.4SECTION 866.6040
     866.6040 Gene expression profiling test system for breast cancer prognosis.
21:8.0.1.1.20.7.1.5SECTION 866.6050
     866.6050 Ovarian adnexal mass assessment score test system.
21:8.0.1.1.20.7.1.6SECTION 866.6060
     866.6060 BCR-ABL quantitation test.
21:8.0.1.1.20.7.1.7SECTION 866.6080
     866.6080 Next generation sequencing based tumor profiling test.
21:8.0.1.1.21PART 868
PART 868 - ANESTHESIOLOGY DEVICES
21:8.0.1.1.21.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.21.1.1.1SECTION 868.1
     868.1 Scope.
21:8.0.1.1.21.1.1.2SECTION 868.3
     868.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.21.1.1.3SECTION 868.9
     868.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.21.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.21.2.1.1SECTION 868.1030
     868.1030 Manual algesimeter.
21:8.0.1.1.21.2.1.2SECTION 868.1040
     868.1040 Powered algesimeter.
21:8.0.1.1.21.2.1.3SECTION 868.1075
     868.1075 Argon gas analyzer.
21:8.0.1.1.21.2.1.4SECTION 868.1100
     868.1100 Arterial blood sampling kit.
21:8.0.1.1.21.2.1.5SECTION 868.1120
     868.1120 Indwelling blood oxyhemoglobin concentration analyzer.
21:8.0.1.1.21.2.1.6SECTION 868.1150
     868.1150 Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
21:8.0.1.1.21.2.1.7SECTION 868.1170
     868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.
21:8.0.1.1.21.2.1.8SECTION 868.1200
     868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer.
21:8.0.1.1.21.2.1.9SECTION 868.1400
     868.1400 Carbon dioxide gas analyzer.
21:8.0.1.1.21.2.1.10SECTION 868.1430
     868.1430 Carbon monoxide gas analyzer.
21:8.0.1.1.21.2.1.11SECTION 868.1500
     868.1500 Enflurane gas analyzer.
21:8.0.1.1.21.2.1.12SECTION 868.1505
     868.1505 Ventilatory electrical impedance tomograph.
21:8.0.1.1.21.2.1.13SECTION 868.1575
     868.1575 Gas collection vessel.
21:8.0.1.1.21.2.1.14SECTION 868.1620
     868.1620 Halothane gas analyzer.
21:8.0.1.1.21.2.1.15SECTION 868.1640
     868.1640 Helium gas analyzer.
21:8.0.1.1.21.2.1.16SECTION 868.1670
     868.1670 Neon gas analyzer.
21:8.0.1.1.21.2.1.17SECTION 868.1690
     868.1690 Nitrogen gas analyzer.
21:8.0.1.1.21.2.1.18SECTION 868.1700
     868.1700 Nitrous oxide gas analyzer.
21:8.0.1.1.21.2.1.19SECTION 868.1720
     868.1720 Oxygen gas analyzer.
21:8.0.1.1.21.2.1.20SECTION 868.1730
     868.1730 Oxygen uptake computer.
21:8.0.1.1.21.2.1.21SECTION 868.1750
     868.1750 Pressure plethysmograph.
21:8.0.1.1.21.2.1.22SECTION 868.1760
     868.1760 Volume plethysmograph.
21:8.0.1.1.21.2.1.23SECTION 868.1780
     868.1780 Inspiratory airway pressure meter.
21:8.0.1.1.21.2.1.24SECTION 868.1800
     868.1800 Rhinoanemometer.
21:8.0.1.1.21.2.1.25SECTION 868.1840
     868.1840 Diagnostic spirometer.
21:8.0.1.1.21.2.1.26SECTION 868.1850
     868.1850 Monitoring spirometer.
21:8.0.1.1.21.2.1.27SECTION 868.1860
     868.1860 Peak-flow meter for spirometry.
21:8.0.1.1.21.2.1.28SECTION 868.1870
     868.1870 Gas volume calibrator.
21:8.0.1.1.21.2.1.29SECTION 868.1880
     868.1880 Pulmonary-function data calculator.
21:8.0.1.1.21.2.1.30SECTION 868.1890
     868.1890 Predictive pulmonary-function value calculator.
21:8.0.1.1.21.2.1.31SECTION 868.1900
     868.1900 Diagnostic pulmonary-function interpretation calculator.
21:8.0.1.1.21.2.1.32SECTION 868.1910
     868.1910 Esophageal stethoscope.
21:8.0.1.1.21.2.1.33SECTION 868.1920
     868.1920 Esophageal stethoscope with electrical conductors.
21:8.0.1.1.21.2.1.34SECTION 868.1930
     868.1930 Stethoscope head.
21:8.0.1.1.21.2.1.35SECTION 868.1965
     868.1965 Switching valve (ploss).
21:8.0.1.1.21.2.1.36SECTION 868.1975
     868.1975 Water vapor analyzer.
21:8.0.1.1.21.3SUBPART C
Subpart C - Monitoring Devices
21:8.0.1.1.21.3.1.1SECTION 868.2025
     868.2025 Ultrasonic air embolism monitor.
21:8.0.1.1.21.3.1.2SECTION 868.2300
     868.2300 Bourdon gauge flowmeter.
21:8.0.1.1.21.3.1.3SECTION 868.2320
     868.2320 Uncompensated thorpe tube flowmeter.
21:8.0.1.1.21.3.1.4SECTION 868.2340
     868.2340 Compensated thorpe tube flowmeter.
21:8.0.1.1.21.3.1.5SECTION 868.2350
     868.2350 Gas calibration flowmeter.
21:8.0.1.1.21.3.1.6SECTION 868.2375
     868.2375 Breathing frequency monitor.
21:8.0.1.1.21.3.1.7SECTION 868.2377
     868.2377 Apnea monitor.
21:8.0.1.1.21.3.1.8SECTION 868.2380
     868.2380 Nitric oxide analyzer.
21:8.0.1.1.21.3.1.9SECTION 868.2385
     868.2385 Nitrogen dioxide analyzer.
21:8.0.1.1.21.3.1.10SECTION 868.2450
     868.2450 Lung water monitor.
21:8.0.1.1.21.3.1.11SECTION 868.2480
     868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
21:8.0.1.1.21.3.1.12SECTION 868.2500
     868.2500 Cutaneous oxygen (PcO2) monitor.
21:8.0.1.1.21.3.1.13SECTION 868.2550
     868.2550 Pneumotachometer.
21:8.0.1.1.21.3.1.14SECTION 868.2600
     868.2600 Airway pressure monitor.
21:8.0.1.1.21.3.1.15SECTION 868.2610
     868.2610 Gas pressure gauge.
21:8.0.1.1.21.3.1.16SECTION 868.2620
     868.2620 Gas pressure calibrator.
21:8.0.1.1.21.3.1.17SECTION 868.2700
     868.2700 Pressure regulator.
21:8.0.1.1.21.3.1.18SECTION 868.2775
     868.2775 Electrical peripheral nerve stimulator.
21:8.0.1.1.21.3.1.19SECTION 868.2875
     868.2875 Differential pressure transducer.
21:8.0.1.1.21.3.1.20SECTION 868.2885
     868.2885 Gas flow transducer.
21:8.0.1.1.21.3.1.21SECTION 868.2900
     868.2900 Gas pressure transducer.
21:8.0.1.1.21.4SUBPART D
Subparts D-E [Reserved]
21:8.0.1.1.21.5SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.21.5.1.1SECTION 868.5090
     868.5090 Emergency airway needle.
21:8.0.1.1.21.5.1.2SECTION 868.5100
     868.5100 Nasopharyngeal airway.
21:8.0.1.1.21.5.1.3SECTION 868.5105
     868.5105 External negative pressure airway aid.
21:8.0.1.1.21.5.1.4SECTION 868.5110
     868.5110 Oropharyngeal airway.
21:8.0.1.1.21.5.1.5SECTION 868.5115
     868.5115 Device to relieve acute upper airway obstruction.
21:8.0.1.1.21.5.1.6SECTION 868.5120
     868.5120 Anesthesia conduction catheter.
21:8.0.1.1.21.5.1.7SECTION 868.5130
     868.5130 Anesthesia conduction filter.
21:8.0.1.1.21.5.1.8SECTION 868.5140
     868.5140 Anesthesia conduction kit.
21:8.0.1.1.21.5.1.9SECTION 868.5150
     868.5150 Anesthesia conduction needle.
21:8.0.1.1.21.5.1.10SECTION 868.5160
     868.5160 Gas machine for anesthesia or analgesia.
21:8.0.1.1.21.5.1.11SECTION 868.5165
     868.5165 Nitric oxide administration apparatus.
21:8.0.1.1.21.5.1.12SECTION 868.5170
     868.5170 Laryngotracheal topical anesthesia applicator.
21:8.0.1.1.21.5.1.13SECTION 868.5180
     868.5180 Rocking bed.
21:8.0.1.1.21.5.1.14SECTION 868.5220
     868.5220 Blow bottle.
21:8.0.1.1.21.5.1.15SECTION 868.5240
     868.5240 Anesthesia breathing circuit.
21:8.0.1.1.21.5.1.16SECTION 868.5250
     868.5250 Breathing circuit circulator.
21:8.0.1.1.21.5.1.17SECTION 868.5260
     868.5260 Breathing circuit bacterial filter.
21:8.0.1.1.21.5.1.18SECTION 868.5270
     868.5270 Breathing system heater.
21:8.0.1.1.21.5.1.19SECTION 868.5273
     868.5273 Positive airway pressure delivery system.
21:8.0.1.1.21.5.1.20SECTION 868.5280
     868.5280 Breathing tube support.
21:8.0.1.1.21.5.1.21SECTION 868.5300
     868.5300 Carbon dioxide absorbent.
21:8.0.1.1.21.5.1.22SECTION 868.5310
     868.5310 Carbon dioxide absorber.
21:8.0.1.1.21.5.1.23SECTION 868.5320
     868.5320 Reservoir bag.
21:8.0.1.1.21.5.1.24SECTION 868.5330
     868.5330 Breathing gas mixer.
21:8.0.1.1.21.5.1.25SECTION 868.5340
     868.5340 Nasal oxygen cannula.
21:8.0.1.1.21.5.1.26SECTION 868.5350
     868.5350 Nasal oxygen catheter.
21:8.0.1.1.21.5.1.27SECTION 868.5365
     868.5365 Posture chair for cardiac or pulmonary treatment.
21:8.0.1.1.21.5.1.28SECTION 868.5375
     868.5375 Heat and moisture condenser (artificial nose).
21:8.0.1.1.21.5.1.29SECTION 868.5400
     868.5400 Electroanesthesia apparatus.
21:8.0.1.1.21.5.1.30SECTION 868.5420
     868.5420 Ether hook.
21:8.0.1.1.21.5.1.31SECTION 868.5430
     868.5430 Gas-scavenging apparatus.
21:8.0.1.1.21.5.1.32SECTION 868.5440
     868.5440 Portable oxygen generator.
21:8.0.1.1.21.5.1.33SECTION 868.5450
     868.5450 Respiratory gas humidifier.
21:8.0.1.1.21.5.1.34SECTION 868.5454
     868.5454 High flow humidified oxygen delivery device.
21:8.0.1.1.21.5.1.35SECTION 868.5460
     868.5460 Therapeutic humidifier for home use.
21:8.0.1.1.21.5.1.36SECTION 868.5470
     868.5470 Hyperbaric chamber.
21:8.0.1.1.21.5.1.37SECTION 868.5530
     868.5530 Flexible laryngoscope.
21:8.0.1.1.21.5.1.38SECTION 868.5540
     868.5540 Rigid laryngoscope.
21:8.0.1.1.21.5.1.39SECTION 868.5550
     868.5550 Anesthetic gas mask.
21:8.0.1.1.21.5.1.40SECTION 868.5560
     868.5560 Gas mask head strap.
21:8.0.1.1.21.5.1.41SECTION 868.5570
     868.5570 Nonrebreathing mask.
21:8.0.1.1.21.5.1.42SECTION 868.5580
     868.5580 Oxygen mask.
21:8.0.1.1.21.5.1.43SECTION 868.5590
     868.5590 Scavenging mask.
21:8.0.1.1.21.5.1.44SECTION 868.5600
     868.5600 Venturi mask.
21:8.0.1.1.21.5.1.45SECTION 868.5620
     868.5620 Breathing mouthpiece.
21:8.0.1.1.21.5.1.46SECTION 868.5630
     868.5630 Nebulizer.
21:8.0.1.1.21.5.1.47SECTION 868.5640
     868.5640 Medicinal nonventilatory nebulizer (atomizer).
21:8.0.1.1.21.5.1.48SECTION 868.5650
     868.5650 Esophageal obturator.
21:8.0.1.1.21.5.1.49SECTION 868.5655
     868.5655 Portable liquid oxygen unit.
21:8.0.1.1.21.5.1.50SECTION 868.5665
     868.5665 Powered percussor.
21:8.0.1.1.21.5.1.51SECTION 868.5675
     868.5675 Rebreathing device.
21:8.0.1.1.21.5.1.52SECTION 868.5690
     868.5690 Incentive spirometer.
21:8.0.1.1.21.5.1.53SECTION 868.5700
     868.5700 Nonpowered oxygen tent.
21:8.0.1.1.21.5.1.54SECTION 868.5710
     868.5710 Electrically powered oxygen tent.
21:8.0.1.1.21.5.1.55SECTION 868.5720
     868.5720 Bronchial tube.
21:8.0.1.1.21.5.1.56SECTION 868.5730
     868.5730 Tracheal tube.
21:8.0.1.1.21.5.1.57SECTION 868.5740
     868.5740 Tracheal/bronchial differential ventilation tube.
21:8.0.1.1.21.5.1.58SECTION 868.5750
     868.5750 Inflatable tracheal tube cuff.
21:8.0.1.1.21.5.1.59SECTION 868.5760
     868.5760 Cuff spreader.
21:8.0.1.1.21.5.1.60SECTION 868.5770
     868.5770 Tracheal tube fixation device.
21:8.0.1.1.21.5.1.61SECTION 868.5780
     868.5780 Tube introduction forceps.
21:8.0.1.1.21.5.1.62SECTION 868.5790
     868.5790 Tracheal tube stylet.
21:8.0.1.1.21.5.1.63SECTION 868.5795
     868.5795 Tracheal tube cleaning brush.
21:8.0.1.1.21.5.1.64SECTION 868.5800
     868.5800 Tracheostomy tube and tube cuff.
21:8.0.1.1.21.5.1.65SECTION 868.5810
     868.5810 Airway connector.
21:8.0.1.1.21.5.1.66SECTION 868.5820
     868.5820 Dental protector.
21:8.0.1.1.21.5.1.67SECTION 868.5830
     868.5830 Autotransfusion apparatus.
21:8.0.1.1.21.5.1.68SECTION 868.5860
     868.5860 Pressure tubing and accessories.
21:8.0.1.1.21.5.1.69SECTION 868.5870
     868.5870 Nonrebreathing valve.
21:8.0.1.1.21.5.1.70SECTION 868.5880
     868.5880 Anesthetic vaporizer.
21:8.0.1.1.21.5.1.71SECTION 868.5895
     868.5895 Continuous ventilator.
21:8.0.1.1.21.5.1.72SECTION 868.5905
     868.5905 Noncontinuous ventilator (IPPB).
21:8.0.1.1.21.5.1.73SECTION 868.5915
     868.5915 Manual emergency ventilator.
21:8.0.1.1.21.5.1.74SECTION 868.5925
     868.5925 Powered emergency ventilator.
21:8.0.1.1.21.5.1.75SECTION 868.5935
     868.5935 External negative pressure ventilator.
21:8.0.1.1.21.5.1.76SECTION 868.5955
     868.5955 Intermittent mandatory ventilation attachment.
21:8.0.1.1.21.5.1.77SECTION 868.5965
     868.5965 Positive end expiratory pressure breathing attachment.
21:8.0.1.1.21.5.1.78SECTION 868.5975
     868.5975 Ventilator tubing.
21:8.0.1.1.21.5.1.79SECTION 868.5995
     868.5995 Tee drain (water trap).
21:8.0.1.1.21.6SUBPART G
Subpart G - Miscellaneous
21:8.0.1.1.21.6.1.1SECTION 868.6100
     868.6100 Anesthetic cabinet, table, or tray.
21:8.0.1.1.21.6.1.2SECTION 868.6175
     868.6175 Cardiopulmonary emergency cart.
21:8.0.1.1.21.6.1.3SECTION 868.6225
     868.6225 Nose clip.
21:8.0.1.1.21.6.1.4SECTION 868.6250
     868.6250 Portable air compressor.
21:8.0.1.1.21.6.1.5SECTION 868.6400
     868.6400 Calibration gas.
21:8.0.1.1.21.6.1.6SECTION 868.6700
     868.6700 Anesthesia stool.
21:8.0.1.1.21.6.1.7SECTION 868.6810
     868.6810 Tracheobronchial suction catheter.
21:8.0.1.1.21.6.1.8SECTION 868.6820
     868.6820 Patient position support.
21:8.0.1.1.21.6.1.9SECTION 868.6885
     868.6885 Medical gas yoke assembly.
21:8.0.1.1.22PART 870
PART 870 - CARDIOVASCULAR DEVICES
21:8.0.1.1.22.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.22.1.1.1SECTION 870.1
     870.1 Scope.
21:8.0.1.1.22.1.1.2SECTION 870.3
     870.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.22.1.1.3SECTION 870.9
     870.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.22.2SUBPART B
Subpart B - Cardiovascular Diagnostic Devices
21:8.0.1.1.22.2.1.1SECTION 870.1025
     870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
21:8.0.1.1.22.2.1.2SECTION 870.1100
     870.1100 Blood pressure alarm.
21:8.0.1.1.22.2.1.3SECTION 870.1110
     870.1110 Blood pressure computer.
21:8.0.1.1.22.2.1.4SECTION 870.1120
     870.1120 Blood pressure cuff.
21:8.0.1.1.22.2.1.5SECTION 870.1130
     870.1130 Noninvasive blood pressure measurement system.
21:8.0.1.1.22.2.1.6SECTION 870.1140
     870.1140 Venous blood pressure manometer.
21:8.0.1.1.22.2.1.7SECTION 870.1200
     870.1200 Diagnostic intravascular catheter.
21:8.0.1.1.22.2.1.8SECTION 870.1210
     870.1210 Continuous flush catheter.
21:8.0.1.1.22.2.1.9SECTION 870.1220
     870.1220 Electrode recording catheter or electrode recording probe.
21:8.0.1.1.22.2.1.10SECTION 870.1230
     870.1230 Fiberoptic oximeter catheter.
21:8.0.1.1.22.2.1.11SECTION 870.1240
     870.1240 Flow-directed catheter.
21:8.0.1.1.22.2.1.12SECTION 870.1250
     870.1250 Percutaneous catheter.
21:8.0.1.1.22.2.1.13SECTION 870.1251
     870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.
21:8.0.1.1.22.2.1.14SECTION 870.1255
     870.1255 Balloon aortic valvuloplasty catheter.
21:8.0.1.1.22.2.1.15SECTION 870.1270
     870.1270 Intracavitary phonocatheter system.
21:8.0.1.1.22.2.1.16SECTION 870.1280
     870.1280 Steerable catheter.
21:8.0.1.1.22.2.1.17SECTION 870.1290
     870.1290 Steerable catheter control system.
21:8.0.1.1.22.2.1.18SECTION 870.1300
     870.1300 Catheter cannula.
21:8.0.1.1.22.2.1.19SECTION 870.1310
     870.1310 Vessel dilator for percutaneous catheterization.
21:8.0.1.1.22.2.1.20SECTION 870.1330
     870.1330 Catheter guide wire.
21:8.0.1.1.22.2.1.21SECTION 870.1340
     870.1340 Catheter introducer.
21:8.0.1.1.22.2.1.22SECTION 870.1350
     870.1350 Catheter balloon repair kit.
21:8.0.1.1.22.2.1.23SECTION 870.1360
     870.1360 Trace microsphere.
21:8.0.1.1.22.2.1.24SECTION 870.1370
     870.1370 Catheter tip occluder.
21:8.0.1.1.22.2.1.25SECTION 870.1380
     870.1380 Catheter stylet.
21:8.0.1.1.22.2.1.26SECTION 870.1390
     870.1390 Trocar.
21:8.0.1.1.22.2.1.27SECTION 870.1415
     870.1415 Coronary vascular physiologic simulation software device.
21:8.0.1.1.22.2.1.28SECTION 870.1425
     870.1425 Programmable diagnostic computer.
21:8.0.1.1.22.2.1.29SECTION 870.1435
     870.1435 Single-function, preprogrammed diagnostic computer.
21:8.0.1.1.22.2.1.30SECTION 870.1450
     870.1450 Densitometer.
21:8.0.1.1.22.2.1.31SECTION 870.1650
     870.1650 Angiographic injector and syringe.
21:8.0.1.1.22.2.1.32SECTION 870.1660
     870.1660 Indicator injector.
21:8.0.1.1.22.2.1.33SECTION 870.1670
     870.1670 Syringe actuator for an injector.
21:8.0.1.1.22.2.1.34SECTION 870.1750
     870.1750 External programmable pacemaker pulse generator.
21:8.0.1.1.22.2.1.35SECTION 870.1800
     870.1800 Withdrawal-infusion pump.
21:8.0.1.1.22.2.1.36SECTION 870.1875
     870.1875 Stethoscope.
21:8.0.1.1.22.2.1.37SECTION 870.1915
     870.1915 Thermodilution probe.
21:8.0.1.1.22.3SUBPART C
Subpart C - Cardiovascular Monitoring Devices
21:8.0.1.1.22.3.1.1SECTION 870.2050
     870.2050 Biopotential amplifier and signal conditioner.
21:8.0.1.1.22.3.1.2SECTION 870.2060
     870.2060 Transducer signal amplifier and conditioner.
21:8.0.1.1.22.3.1.3SECTION 870.2100
     870.2100 Cardiovascular blood flowmeter.
21:8.0.1.1.22.3.1.4SECTION 870.2120
     870.2120 Extravascular blood flow probe.
21:8.0.1.1.22.3.1.5SECTION 870.2200
     870.2200 Adjunctive cardiovascular status indicator.
21:8.0.1.1.22.3.1.6SECTION 870.2300
     870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
21:8.0.1.1.22.3.1.7SECTION 870.2310
     870.2310 Apex cardiograph (vibrocardiograph).
21:8.0.1.1.22.3.1.8SECTION 870.2320
     870.2320 Ballistocardiograph.
21:8.0.1.1.22.3.1.9SECTION 870.2330
     870.2330 Echocardiograph.
21:8.0.1.1.22.3.1.10SECTION 870.2340
     870.2340 Electrocardiograph.
21:8.0.1.1.22.3.1.11SECTION 870.2350
     870.2350 Electrocardiograph lead switching adaptor.
21:8.0.1.1.22.3.1.12SECTION 870.2360
     870.2360 Electrocardiograph electrode.
21:8.0.1.1.22.3.1.13SECTION 870.2370
     870.2370 Electrocardiograph surface electrode tester.
21:8.0.1.1.22.3.1.14SECTION 870.2390
     870.2390 Phonocardiograph.
21:8.0.1.1.22.3.1.15SECTION 870.2400
     870.2400 Vectorcardiograph.
21:8.0.1.1.22.3.1.16SECTION 870.2450
     870.2450 Medical cathode-ray tube display.
21:8.0.1.1.22.3.1.17SECTION 870.2600
     870.2600 Signal isolation system.
21:8.0.1.1.22.3.1.18SECTION 870.2620
     870.2620 Line isolation monitor.
21:8.0.1.1.22.3.1.19SECTION 870.2640
     870.2640 Portable leakage current alarm.
21:8.0.1.1.22.3.1.20SECTION 870.2675
     870.2675 Oscillometer.
21:8.0.1.1.22.3.1.21SECTION 870.2700
     870.2700 Oximeter.
21:8.0.1.1.22.3.1.22SECTION 870.2710
     870.2710 Ear oximeter.
21:8.0.1.1.22.3.1.23SECTION 870.2750
     870.2750 Impedance phlebograph.
21:8.0.1.1.22.3.1.24SECTION 870.2770
     870.2770 Impedance plethysmograph.
21:8.0.1.1.22.3.1.25SECTION 870.2780
     870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
21:8.0.1.1.22.3.1.26SECTION 870.2800
     870.2800 Medical magnetic tape recorder.
21:8.0.1.1.22.3.1.27SECTION 870.2810
     870.2810 Paper chart recorder.
21:8.0.1.1.22.3.1.28SECTION 870.2840
     870.2840 Apex cardiographic transducer.
21:8.0.1.1.22.3.1.29SECTION 870.2850
     870.2850 Extravascular blood pressure transducer.
21:8.0.1.1.22.3.1.30SECTION 870.2855
     870.2855 Implantable Intra-aneurysm Pressure Measurement System.
21:8.0.1.1.22.3.1.31SECTION 870.2860
     870.2860 Heart sound transducer.
21:8.0.1.1.22.3.1.32SECTION 870.2870
     870.2870 Catheter tip pressure transducer.
21:8.0.1.1.22.3.1.33SECTION 870.2880
     870.2880 Ultrasonic transducer.
21:8.0.1.1.22.3.1.34SECTION 870.2890
     870.2890 Vessel occlusion transducer.
21:8.0.1.1.22.3.1.35SECTION 870.2900
     870.2900 Patient transducer and electrode cable (including connector).
21:8.0.1.1.22.3.1.36SECTION 870.2910
     870.2910 Radiofrequency physiological signal transmitter and receiver.
21:8.0.1.1.22.3.1.37SECTION 870.2920
     870.2920 Telephone electrocardiograph transmitter and receiver.
21:8.0.1.1.22.4SUBPART D
Subpart D - Cardiovascular Prosthetic Devices
21:8.0.1.1.22.4.1.1SECTION 870.3250
     870.3250 Vascular clip.
21:8.0.1.1.22.4.1.2SECTION 870.3260
     870.3260 Vena cava clip.
21:8.0.1.1.22.4.1.3SECTION 870.3300
     870.3300 Vascular embolization device.
21:8.0.1.1.22.4.1.4SECTION 870.3375
     870.3375 Cardiovascular intravascular filter.
21:8.0.1.1.22.4.1.5SECTION 870.3450
     870.3450 Vascular graft prosthesis.
21:8.0.1.1.22.4.1.6SECTION 870.3460
     870.3460 Endovascular Suturing System.
21:8.0.1.1.22.4.1.7SECTION 870.3470
     870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
21:8.0.1.1.22.4.1.8SECTION 870.3535
     870.3535 Intra-aortic balloon and control system.
21:8.0.1.1.22.4.1.9SECTION 870.3545
     870.3545 Ventricular bypass (assist) device.
21:8.0.1.1.22.4.1.10SECTION 870.3600
     870.3600 External pacemaker pulse generator.
21:8.0.1.1.22.4.1.11SECTION 870.3605
     870.3605 Pacing system analyzer.
21:8.0.1.1.22.4.1.12SECTION 870.3610
     870.3610 Implantable pacemaker pulse generator.
21:8.0.1.1.22.4.1.13SECTION 870.3620
     870.3620 Pacemaker lead adaptor.
21:8.0.1.1.22.4.1.14SECTION 870.3630
     870.3630 Pacemaker generator function analyzer.
21:8.0.1.1.22.4.1.15SECTION 870.3640
     870.3640 Indirect pacemaker generator function analyzer.
21:8.0.1.1.22.4.1.16SECTION 870.3650
     870.3650 Pacemaker polymeric mesh bag.
21:8.0.1.1.22.4.1.17SECTION 870.3670
     870.3670 Pacemaker charger.
21:8.0.1.1.22.4.1.18SECTION 870.3680
     870.3680 Cardiovascular permanent or temporary pacemaker electrode.
21:8.0.1.1.22.4.1.19SECTION 870.3690
     870.3690 Pacemaker test magnet.
21:8.0.1.1.22.4.1.20SECTION 870.3700
     870.3700 Pacemaker programmers.
21:8.0.1.1.22.4.1.21SECTION 870.3710
     870.3710 Pacemaker repair or replacement material.
21:8.0.1.1.22.4.1.22SECTION 870.3720
     870.3720 Pacemaker electrode function tester.
21:8.0.1.1.22.4.1.23SECTION 870.3730
     870.3730 Pacemaker service tools.
21:8.0.1.1.22.4.1.24SECTION 870.3800
     870.3800 Annuloplasty ring.
21:8.0.1.1.22.4.1.25SECTION 870.3850
     870.3850 Carotid sinus nerve stimulator.
21:8.0.1.1.22.4.1.26SECTION 870.3925
     870.3925 Replacement heart valve.
21:8.0.1.1.22.4.1.27SECTION 870.3935
     870.3935 Prosthetic heart valve holder.
21:8.0.1.1.22.4.1.28SECTION 870.3945
     870.3945 Prosthetic heart valve sizer.
21:8.0.1.1.22.5SUBPART E
Subpart E - Cardiovascular Surgical Devices
21:8.0.1.1.22.5.1.1SECTION 870.4075
     870.4075 Endomyocardial biopsy device.
21:8.0.1.1.22.5.1.2SECTION 870.4100
     870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
21:8.0.1.1.22.5.1.3SECTION 870.4200
     870.4200 Cardiopulmonary bypass accessory equipment.
21:8.0.1.1.22.5.1.4SECTION 870.4205
     870.4205 Cardiopulmonary bypass bubble detector.
21:8.0.1.1.22.5.1.5SECTION 870.4210
     870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
21:8.0.1.1.22.5.1.6SECTION 870.4220
     870.4220 Cardiopulmonary bypass heart-lung machine console.
21:8.0.1.1.22.5.1.7SECTION 870.4230
     870.4230 Cardiopulmonary bypass defoamer.
21:8.0.1.1.22.5.1.8SECTION 870.4240
     870.4240 Cardiopulmonary bypass heat exchanger.
21:8.0.1.1.22.5.1.9SECTION 870.4250
     870.4250 Cardiopulmonary bypass temperature controller.
21:8.0.1.1.22.5.1.10SECTION 870.4260
     870.4260 Cardiopulmonary bypass arterial line blood filter.
21:8.0.1.1.22.5.1.11SECTION 870.4270
     870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
21:8.0.1.1.22.5.1.12SECTION 870.4280
     870.4280 Cardiopulmonary prebypass filter.
21:8.0.1.1.22.5.1.13SECTION 870.4290
     870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
21:8.0.1.1.22.5.1.14SECTION 870.4300
     870.4300 Cardiopulmonary bypass gas control unit.
21:8.0.1.1.22.5.1.15SECTION 870.4310
     870.4310 Cardiopulmonary bypass coronary pressure gauge.
21:8.0.1.1.22.5.1.16SECTION 870.4320
     870.4320 Cardiopulmonary bypass pulsatile flow generator.
21:8.0.1.1.22.5.1.17SECTION 870.4330
     870.4330 Cardiopulmonary bypass on-line blood gas monitor.
21:8.0.1.1.22.5.1.18SECTION 870.4340
     870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
21:8.0.1.1.22.5.1.19SECTION 870.4350
     870.4350 Cardiopulmonary bypass oxygenator.
21:8.0.1.1.22.5.1.20SECTION 870.4360
     870.4360 Nonroller-type blood pump.
21:8.0.1.1.22.5.1.21SECTION 870.4370
     870.4370 Roller-type cardiopulmonary bypass blood pump.
21:8.0.1.1.22.5.1.22SECTION 870.4380
     870.4380 Cardiopulmonary bypass pump speed control.
21:8.0.1.1.22.5.1.23SECTION 870.4390
     870.4390 Cardiopulmonary bypass pump tubing.
21:8.0.1.1.22.5.1.24SECTION 870.4400
     870.4400 Cardiopulmonary bypass blood reservoir.
21:8.0.1.1.22.5.1.25SECTION 870.4410
     870.4410 Cardiopulmonary bypass in-line blood gas sensor.
21:8.0.1.1.22.5.1.26SECTION 870.4420
     870.4420 Cardiopulmonary bypass cardiotomy return sucker.
21:8.0.1.1.22.5.1.27SECTION 870.4430
     870.4430 Cardiopulmonary bypass intracardiac suction control.
21:8.0.1.1.22.5.1.28SECTION 870.4450
     870.4450 Vascular clamp.
21:8.0.1.1.22.5.1.29SECTION 870.4475
     870.4475 Surgical vessel dilator.
21:8.0.1.1.22.5.1.30SECTION 870.4500
     870.4500 Cardiovascular surgical instruments.
21:8.0.1.1.22.5.1.31SECTION 870.4510
     870.4510 Apical closure device.
21:8.0.1.1.22.5.1.32SECTION 870.4875
     870.4875 Intraluminal artery stripper.
21:8.0.1.1.22.5.1.33SECTION 870.4885
     870.4885 External vein stripper.
21:8.0.1.1.22.6SUBPART F
Subpart F - Cardiovascular Therapeutic Devices
21:8.0.1.1.22.6.1.1SECTION 870.5050
     870.5050 Patient care suction apparatus.
21:8.0.1.1.22.6.1.2SECTION 870.5100
     870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
21:8.0.1.1.22.6.1.3SECTION 870.5150
     870.5150 Embolectomy catheter.
21:8.0.1.1.22.6.1.4SECTION 870.5175
     870.5175 Septostomy catheter.
21:8.0.1.1.22.6.1.5SECTION 870.5200
     870.5200 External cardiac compressor.
21:8.0.1.1.22.6.1.6SECTION 870.5210
     870.5210 Cardiopulmonary resuscitation (CPR) aid.
21:8.0.1.1.22.6.1.7SECTION 870.5225
     870.5225 External counter-pulsating device.
21:8.0.1.1.22.6.1.8SECTION 870.5300
     870.5300 DC-defibrillator (including paddles).
21:8.0.1.1.22.6.1.9SECTION 870.5310
     870.5310 Automated external defibrillator system.
21:8.0.1.1.22.6.1.10SECTION 870.5325
     870.5325 Defibrillator tester.
21:8.0.1.1.22.6.1.11SECTION 870.5550
     870.5550 External transcutaneous cardiac pacemaker (noninvasive).
21:8.0.1.1.22.6.1.12SECTION 870.5700
     870.5700 Steerable cardiac ablation catheter remote control system.
21:8.0.1.1.22.6.1.13SECTION 870.5800
     870.5800 Compressible limb sleeve.
21:8.0.1.1.22.6.1.14SECTION 870.5900
     870.5900 Thermal regulating system.
21:8.0.1.1.22.6.1.15SECTION 870.5910
     870.5910 Esophageal thermal regulation device.
21:8.0.1.1.22.6.1.16SECTION 870.5925
     870.5925 Automatic rotating tourniquet.
21:8.0.1.1.23PART 872
PART 872 - DENTAL DEVICES
21:8.0.1.1.23.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.23.1.1.1SECTION 872.1
     872.1 Scope.
21:8.0.1.1.23.1.1.2SECTION 872.3
     872.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.23.1.1.3SECTION 872.9
     872.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.23.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.23.2.1.1SECTION 872.1500
     872.1500 Gingival fluid measurer.
21:8.0.1.1.23.2.1.2SECTION 872.1720
     872.1720 Pulp tester.
21:8.0.1.1.23.2.1.3SECTION 872.1730
     872.1730 Electrode gel for pulp testers.
21:8.0.1.1.23.2.1.4SECTION 872.1740
     872.1740 Caries detection device.
21:8.0.1.1.23.2.1.5SECTION 872.1745
     872.1745 Laser fluorescence caries detection device.
21:8.0.1.1.23.2.1.6SECTION 872.1800
     872.1800 Extraoral source x-ray system.
21:8.0.1.1.23.2.1.7SECTION 872.1810
     872.1810 Intraoral source x-ray system.
21:8.0.1.1.23.2.1.8SECTION 872.1820
     872.1820 Dental x-ray exposure alignment device.
21:8.0.1.1.23.2.1.9SECTION 872.1830
     872.1830 Cephalometer.
21:8.0.1.1.23.2.1.10SECTION 872.1840
     872.1840 Dental x-ray position indicating device.
21:8.0.1.1.23.2.1.11SECTION 872.1850
     872.1850 Lead-lined position indicator.
21:8.0.1.1.23.2.1.12SECTION 872.1870
     872.1870 Sulfide detection device.
21:8.0.1.1.23.2.1.13SECTION 872.1905
     872.1905 Dental x-ray film holder.
21:8.0.1.1.23.2.1.14SECTION 872.2050
     872.2050 Dental sonography device.
21:8.0.1.1.23.2.1.15SECTION 872.2060
     872.2060 Jaw tracking device.
21:8.0.1.1.23.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.23.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.23.4.1.1SECTION 872.3060
     872.3060 Noble metal alloy.
21:8.0.1.1.23.4.1.2SECTION 872.3070
     872.3070 Dental amalgam, mercury, and amalgam alloy.
21:8.0.1.1.23.4.1.3SECTION 872.3080
     872.3080 Mercury and alloy dispenser.
21:8.0.1.1.23.4.1.4SECTION 872.3100
     872.3100 Dental amalgamator.
21:8.0.1.1.23.4.1.5SECTION 872.3110
     872.3110 Dental amalgam capsule.
21:8.0.1.1.23.4.1.6SECTION 872.3130
     872.3130 Preformed anchor.
21:8.0.1.1.23.4.1.7SECTION 872.3140
     872.3140 Resin applicator.
21:8.0.1.1.23.4.1.8SECTION 872.3150
     872.3150 Articulator.
21:8.0.1.1.23.4.1.9SECTION 872.3165
     872.3165 Precision attachment.
21:8.0.1.1.23.4.1.10SECTION 872.3200
     872.3200 Resin tooth bonding agent.
21:8.0.1.1.23.4.1.11SECTION 872.3220
     872.3220 Facebow.
21:8.0.1.1.23.4.1.12SECTION 872.3240
     872.3240 Dental bur.
21:8.0.1.1.23.4.1.13SECTION 872.3250
     872.3250 Calcium hydroxide cavity liner.
21:8.0.1.1.23.4.1.14SECTION 872.3260
     872.3260 Cavity varnish.
21:8.0.1.1.23.4.1.15SECTION 872.3275
     872.3275 Dental cement.
21:8.0.1.1.23.4.1.16SECTION 872.3285
     872.3285 Preformed clasp.
21:8.0.1.1.23.4.1.17SECTION 872.3300
     872.3300 Hydrophilic resin coating for dentures.
21:8.0.1.1.23.4.1.18SECTION 872.3310
     872.3310 Coating material for resin fillings.
21:8.0.1.1.23.4.1.19SECTION 872.3330
     872.3330 Preformed crown.
21:8.0.1.1.23.4.1.20SECTION 872.3350
     872.3350 Gold or stainless steel cusp.
21:8.0.1.1.23.4.1.21SECTION 872.3360
     872.3360 Preformed cusp.
21:8.0.1.1.23.4.1.22SECTION 872.3400
     872.3400 Karaya and sodium borate with or without acacia denture adhesive.
21:8.0.1.1.23.4.1.23SECTION 872.3410
     872.3410 Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.
21:8.0.1.1.23.4.1.24SECTION 872.3420
     872.3420 Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive.
21:8.0.1.1.23.4.1.25SECTION 872.3450
     872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive.
21:8.0.1.1.23.4.1.26SECTION 872.3480
     872.3480 Polyacrylamide polymer (modified cationic) denture adhesive.
21:8.0.1.1.23.4.1.27SECTION 872.3490
     872.3490 Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
21:8.0.1.1.23.4.1.28SECTION 872.3500
     872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
21:8.0.1.1.23.4.1.29SECTION 872.3520
     872.3520 OTC denture cleanser.
21:8.0.1.1.23.4.1.30SECTION 872.3530
     872.3530 Mechanical denture cleaner.
21:8.0.1.1.23.4.1.31SECTION 872.3540
     872.3540 OTC denture cushion or pad.
21:8.0.1.1.23.4.1.32SECTION 872.3560
     872.3560 OTC denture reliner.
21:8.0.1.1.23.4.1.33SECTION 872.3570
     872.3570 OTC denture repair kit.
21:8.0.1.1.23.4.1.34SECTION 872.3580
     872.3580 Preformed gold denture tooth.
21:8.0.1.1.23.4.1.35SECTION 872.3590
     872.3590 Preformed plastic denture tooth.
21:8.0.1.1.23.4.1.36SECTION 872.3600
     872.3600 Partially fabricated denture kit.
21:8.0.1.1.23.4.1.37SECTION 872.3630
     872.3630 Endosseous dental implant abutment.
21:8.0.1.1.23.4.1.38SECTION 872.3640
     872.3640 Endosseous dental implant.
21:8.0.1.1.23.4.1.39SECTION 872.3645
     872.3645 Subperiosteal implant material.
21:8.0.1.1.23.4.1.40SECTION 872.3660
     872.3660 Impression material.
21:8.0.1.1.23.4.1.41SECTION 872.3661
     872.3661 Optical Impression Systems for CAD/CAM.
21:8.0.1.1.23.4.1.42SECTION 872.3670
     872.3670 Resin impression tray material.
21:8.0.1.1.23.4.1.43SECTION 872.3680
     872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials.
21:8.0.1.1.23.4.1.44SECTION 872.3690
     872.3690 Tooth shade resin material.
21:8.0.1.1.23.4.1.45SECTION 872.3710
     872.3710 Base metal alloy.
21:8.0.1.1.23.4.1.46SECTION 872.3730
     872.3730 Pantograph.
21:8.0.1.1.23.4.1.47SECTION 872.3740
     872.3740 Retentive and splinting pin.
21:8.0.1.1.23.4.1.48SECTION 872.3750
     872.3750 Bracket adhesive resin and tooth conditioner.
21:8.0.1.1.23.4.1.49SECTION 872.3760
     872.3760 Denture relining, repairing, or rebasing resin.
21:8.0.1.1.23.4.1.50SECTION 872.3765
     872.3765 Pit and fissure sealant and conditioner.
21:8.0.1.1.23.4.1.51SECTION 872.3770
     872.3770 Temporary crown and bridge resin.
21:8.0.1.1.23.4.1.52SECTION 872.3810
     872.3810 Root canal post.
21:8.0.1.1.23.4.1.53SECTION 872.3820
     872.3820 Root canal filling resin.
21:8.0.1.1.23.4.1.54SECTION 872.3830
     872.3830 Endodontic paper point.
21:8.0.1.1.23.4.1.55SECTION 872.3840
     872.3840 Endodontic silver point.
21:8.0.1.1.23.4.1.56SECTION 872.3850
     872.3850 Gutta percha.
21:8.0.1.1.23.4.1.57SECTION 872.3890
     872.3890 Endodontic stabilizing splint.
21:8.0.1.1.23.4.1.58SECTION 872.3900
     872.3900 Posterior artificial tooth with a metal insert.
21:8.0.1.1.23.4.1.59SECTION 872.3910
     872.3910 Backing and facing for an artificial tooth.
21:8.0.1.1.23.4.1.60SECTION 872.3920
     872.3920 Porcelain tooth.
21:8.0.1.1.23.4.1.61SECTION 872.3930
     872.3930 Bone grafting material.
21:8.0.1.1.23.4.1.62SECTION 872.3940
     872.3940 Total temporomandibular joint prosthesis.
21:8.0.1.1.23.4.1.63SECTION 872.3950
     872.3950 Glenoid fossa prosthesis.
21:8.0.1.1.23.4.1.64SECTION 872.3960
     872.3960 Mandibular condyle prosthesis.
21:8.0.1.1.23.4.1.65SECTION 872.3970
     872.3970 Interarticular disc prosthesis (interpositional implant).
21:8.0.1.1.23.4.1.66SECTION 872.3980
     872.3980 Endosseous dental implant accessories.
21:8.0.1.1.23.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.23.5.1.1SECTION 872.4120
     872.4120 Bone cutting instrument and accessories.
21:8.0.1.1.23.5.1.2SECTION 872.4130
     872.4130 Intraoral dental drill.
21:8.0.1.1.23.5.1.3SECTION 872.4200
     872.4200 Dental handpiece and accessories.
21:8.0.1.1.23.5.1.4SECTION 872.4465
     872.4465 Gas-powered jet injector.
21:8.0.1.1.23.5.1.5SECTION 872.4475
     872.4475 Spring-powered jet injector.
21:8.0.1.1.23.5.1.6SECTION 872.4535
     872.4535 Dental diamond instrument.
21:8.0.1.1.23.5.1.7SECTION 872.4565
     872.4565 Dental hand instrument.
21:8.0.1.1.23.5.1.8SECTION 872.4600
     872.4600 Intraoral ligature and wire lock.
21:8.0.1.1.23.5.1.9SECTION 872.4620
     872.4620 Fiber optic dental light.
21:8.0.1.1.23.5.1.10SECTION 872.4630
     872.4630 Dental operating light.
21:8.0.1.1.23.5.1.11SECTION 872.4730
     872.4730 Dental injecting needle.
21:8.0.1.1.23.5.1.12SECTION 872.4760
     872.4760 Bone plate.
21:8.0.1.1.23.5.1.13SECTION 872.4770
     872.4770 Temporary mandibular condyle reconstruction plate.
21:8.0.1.1.23.5.1.14SECTION 872.4840
     872.4840 Rotary scaler.
21:8.0.1.1.23.5.1.15SECTION 872.4850
     872.4850 Ultrasonic scaler.
21:8.0.1.1.23.5.1.16SECTION 872.4880
     872.4880 Intraosseous fixation screw or wire.
21:8.0.1.1.23.5.1.17SECTION 872.4920
     872.4920 Dental electrosurgical unit and accessories.
21:8.0.1.1.23.6SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.23.6.1.1SECTION 872.5410
     872.5410 Orthodontic appliance and accessories.
21:8.0.1.1.23.6.1.2SECTION 872.5470
     872.5470 Orthodontic plastic bracket.
21:8.0.1.1.23.6.1.3SECTION 872.5500
     872.5500 Extraoral orthodontic headgear.
21:8.0.1.1.23.6.1.4SECTION 872.5525
     872.5525 Preformed tooth positioner.
21:8.0.1.1.23.6.1.5SECTION 872.5550
     872.5550 Teething ring.
21:8.0.1.1.23.6.1.6SECTION 872.5560
     872.5560 Electrical salivary stimulatory system.
21:8.0.1.1.23.6.1.7SECTION 872.5570
     872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
21:8.0.1.1.23.6.1.8SECTION 872.5571
     872.5571 Auto titration device for oral appliances.
21:8.0.1.1.23.6.1.9SECTION 872.5580
     872.5580 Oral rinse to reduce the adhesion of dental plaque.
21:8.0.1.1.23.7SUBPART G
Subpart G - Miscellaneous Devices
21:8.0.1.1.23.7.1.1SECTION 872.6010
     872.6010 Abrasive device and accessories.
21:8.0.1.1.23.7.1.2SECTION 872.6030
     872.6030 Oral cavity abrasive polishing agent.
21:8.0.1.1.23.7.1.3SECTION 872.6050
     872.6050 Saliva absorber.
21:8.0.1.1.23.7.1.4SECTION 872.6070
     872.6070 Ultraviolet activator for polymerization.
21:8.0.1.1.23.7.1.5SECTION 872.6080
     872.6080 Airbrush.
21:8.0.1.1.23.7.1.6SECTION 872.6100
     872.6100 Anesthetic warmer.
21:8.0.1.1.23.7.1.7SECTION 872.6140
     872.6140 Articulation paper.
21:8.0.1.1.23.7.1.8SECTION 872.6200
     872.6200 Base plate shellac.
21:8.0.1.1.23.7.1.9SECTION 872.6250
     872.6250 Dental chair and accessories.
21:8.0.1.1.23.7.1.10SECTION 872.6290
     872.6290 Prophylaxis cup.
21:8.0.1.1.23.7.1.11SECTION 872.6300
     872.6300 Rubber dam and accessories.
21:8.0.1.1.23.7.1.12SECTION 872.6350
     872.6350 Ultraviolet detector.
21:8.0.1.1.23.7.1.13SECTION 872.6390
     872.6390 Dental floss.
21:8.0.1.1.23.7.1.14SECTION 872.6475
     872.6475 Heat source for bleaching teeth.
21:8.0.1.1.23.7.1.15SECTION 872.6510
     872.6510 Oral irrigation unit.
21:8.0.1.1.23.7.1.16SECTION 872.6570
     872.6570 Impression tube.
21:8.0.1.1.23.7.1.17SECTION 872.6640
     872.6640 Dental operative unit and accessories.
21:8.0.1.1.23.7.1.18SECTION 872.6650
     872.6650 Massaging pick or tip for oral hygiene.
21:8.0.1.1.23.7.1.19SECTION 872.6660
     872.6660 Porcelain powder for clinical use.
21:8.0.1.1.23.7.1.20SECTION 872.6670
     872.6670 Silicate protector.
21:8.0.1.1.23.7.1.21SECTION 872.6710
     872.6710 Boiling water sterilizer.
21:8.0.1.1.23.7.1.22SECTION 872.6730
     872.6730 Endodontic dry heat sterilizer.
21:8.0.1.1.23.7.1.23SECTION 872.6770
     872.6770 Cartridge syringe.
21:8.0.1.1.23.7.1.24SECTION 872.6855
     872.6855 Manual toothbrush.
21:8.0.1.1.23.7.1.25SECTION 872.6865
     872.6865 Powered toothbrush.
21:8.0.1.1.23.7.1.26SECTION 872.6870
     872.6870 Disposable fluoride tray.
21:8.0.1.1.23.7.1.27SECTION 872.6880
     872.6880 Preformed impression tray.
21:8.0.1.1.23.7.1.28SECTION 872.6890
     872.6890 Intraoral dental wax.
21:8.0.1.1.24PART 874
PART 874 - EAR, NOSE, AND THROAT DEVICES
21:8.0.1.1.24.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.24.1.1.1SECTION 874.1
     874.1 Scope.
21:8.0.1.1.24.1.1.2SECTION 874.3
     874.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.24.1.1.3SECTION 874.9
     874.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.24.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.24.2.1.1SECTION 874.1050
     874.1050 Audiometer.
21:8.0.1.1.24.2.1.2SECTION 874.1060
     874.1060 Acoustic chamber for audiometric testing.
21:8.0.1.1.24.2.1.3SECTION 874.1070
     874.1070 Short increment sensitivity index (SISI) adapter.
21:8.0.1.1.24.2.1.4SECTION 874.1080
     874.1080 Audiometer calibration set.
21:8.0.1.1.24.2.1.5SECTION 874.1090
     874.1090 Auditory impedance tester.
21:8.0.1.1.24.2.1.6SECTION 874.1100
     874.1100 Earphone cushion for audiometric testing.
21:8.0.1.1.24.2.1.7SECTION 874.1120
     874.1120 Electronic noise generator for audiometric testing.
21:8.0.1.1.24.2.1.8SECTION 874.1325
     874.1325 Electroglottograph.
21:8.0.1.1.24.2.1.9SECTION 874.1500
     874.1500 Gustometer.
21:8.0.1.1.24.2.1.10SECTION 874.1600
     874.1600 Olfactory test device.
21:8.0.1.1.24.2.1.11SECTION 874.1800
     874.1800 Air or water caloric stimulator.
21:8.0.1.1.24.2.1.12SECTION 874.1820
     874.1820 Surgical nerve stimulator/locator.
21:8.0.1.1.24.2.1.13SECTION 874.1925
     874.1925 Toynbee diagnostic tube.
21:8.0.1.1.24.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.24.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.24.4.1.1SECTION 874.3300
     874.3300 Hearing Aid.
21:8.0.1.1.24.4.1.2SECTION 874.3305
     874.3305 Wireless air-conduction hearing aid.
21:8.0.1.1.24.4.1.3SECTION 874.3310
     874.3310 Hearing aid calibrator and analysis system.
21:8.0.1.1.24.4.1.4SECTION 874.3315
     874.3315 Tympanic membrane contact hearing aid.
21:8.0.1.1.24.4.1.5SECTION 874.3320
     874.3320 Group hearing aid or group auditory trainer.
21:8.0.1.1.24.4.1.6SECTION 874.3325
     874.3325 Self-fitting air-conduction hearing aid.
21:8.0.1.1.24.4.1.7SECTION 874.3330
     874.3330 Master hearing aid.
21:8.0.1.1.24.4.1.8SECTION 874.3340
     874.3340 Active implantable bone conduction hearing system.
21:8.0.1.1.24.4.1.9SECTION 874.3375
     874.3375 Battery-powered artificial larynx.
21:8.0.1.1.24.4.1.10SECTION 874.3400
     874.3400 Tinnitus masker.
21:8.0.1.1.24.4.1.11SECTION 874.3430
     874.3430 Middle ear mold.
21:8.0.1.1.24.4.1.12SECTION 874.3450
     874.3450 Partial ossicular replacement prosthesis.
21:8.0.1.1.24.4.1.13SECTION 874.3495
     874.3495 Total ossicular replacement prosthesis.
21:8.0.1.1.24.4.1.14SECTION 874.3540
     874.3540 Prosthesis modification instrument for ossicular replacement surgery.
21:8.0.1.1.24.4.1.15SECTION 874.3620
     874.3620 Ear, nose, and throat synthetic polymer material.
21:8.0.1.1.24.4.1.16SECTION 874.3695
     874.3695 Mandibular implant facial prosthesis.
21:8.0.1.1.24.4.1.17SECTION 874.3730
     874.3730 Laryngeal prosthesis (Taub design).
21:8.0.1.1.24.4.1.18SECTION 874.3760
     874.3760 Sacculotomy tack (Cody tack)
21:8.0.1.1.24.4.1.19SECTION 874.3820
     874.3820 Endolymphatic shunt.
21:8.0.1.1.24.4.1.20SECTION 874.3850
     874.3850 Endolymphatic shunt tube with valve.
21:8.0.1.1.24.4.1.21SECTION 874.3880
     874.3880 Tympanostomy tube.
21:8.0.1.1.24.4.1.22SECTION 874.3900
     874.3900 Nasal dilator.
21:8.0.1.1.24.4.1.23SECTION 874.3930
     874.3930 Tympanostomy tube with semipermeable membrane.
21:8.0.1.1.24.4.1.24SECTION 874.3950
     874.3950 Transcutaneous air conduction hearing aid system.
21:8.0.1.1.24.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.24.5.1.1SECTION 874.4100
     874.4100 Epistaxis balloon.
21:8.0.1.1.24.5.1.2SECTION 874.4140
     874.4140 Ear, nose, and throat bur.
21:8.0.1.1.24.5.1.3SECTION 874.4175
     874.4175 Nasopharyngeal catheter.
21:8.0.1.1.24.5.1.4SECTION 874.4180
     874.4180 Eustachian tube balloon dilation system.
21:8.0.1.1.24.5.1.5SECTION 874.4250
     874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
21:8.0.1.1.24.5.1.6SECTION 874.4350
     874.4350 Ear, nose, and throat fiberoptic light source and carrier.
21:8.0.1.1.24.5.1.7SECTION 874.4420
     874.4420 Ear, nose, and throat manual surgical instrument.
21:8.0.1.1.24.5.1.8SECTION 874.4490
     874.4490 Argon laser for otology, rhinology, and laryngology.
21:8.0.1.1.24.5.1.9SECTION 874.4500
     874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.
21:8.0.1.1.24.5.1.10SECTION 874.4680
     874.4680 Bronchoscope (flexible or rigid) and accessories.
21:8.0.1.1.24.5.1.11SECTION 874.4710
     874.4710 Esophagoscope (flexible or rigid) and accessories.
21:8.0.1.1.24.5.1.12SECTION 874.4720
     874.4720 Mediastinoscope and accessories.
21:8.0.1.1.24.5.1.13SECTION 874.4750
     874.4750 Laryngostroboscope.
21:8.0.1.1.24.5.1.14SECTION 874.4760
     874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
21:8.0.1.1.24.5.1.15SECTION 874.4770
     874.4770 Otoscope.
21:8.0.1.1.24.5.1.16SECTION 874.4780
     874.4780 Intranasal splint.
21:8.0.1.1.24.5.1.17SECTION 874.4800
     874.4800 Bone particle collector.
21:8.0.1.1.24.6SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.24.6.1.1SECTION 874.5220
     874.5220 Ear, nose, and throat drug administration device.
21:8.0.1.1.24.6.1.2SECTION 874.5300
     874.5300 Ear, nose, and throat examination and treatment unit.
21:8.0.1.1.24.6.1.3SECTION 874.5350
     874.5350 Suction antichoke device.
21:8.0.1.1.24.6.1.4SECTION 874.5370
     874.5370 Tongs antichoke device.
21:8.0.1.1.24.6.1.5SECTION 874.5550
     874.5550 Powered nasal irrigator.
21:8.0.1.1.24.6.1.6SECTION 874.5800
     874.5800 External nasal splint.
21:8.0.1.1.24.6.1.7SECTION 874.5840
     874.5840 Antistammering device.
21:8.0.1.1.24.6.1.8SECTION 874.5900
     874.5900 External upper esophageal sphincter compression device.
21:8.0.1.1.25PART 876
PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES
21:8.0.1.1.25.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.25.1.1.1SECTION 876.1
     876.1 Scope.
21:8.0.1.1.25.1.1.2SECTION 876.3
     876.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.25.1.1.3SECTION 876.9
     876.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.25.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.25.2.1.1SECTION 876.1075
     876.1075 Gastroenterology-urology biopsy instrument.
21:8.0.1.1.25.2.1.2SECTION 876.1080
     876.1080 Gastroenterology-urology accessories to a biopsy instrument.
21:8.0.1.1.25.2.1.3SECTION 876.1300
     876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
21:8.0.1.1.25.2.1.4SECTION 876.1330
     876.1330 Colon capsule endoscopy system.
21:8.0.1.1.25.2.1.5SECTION 876.1400
     876.1400 Stomach pH electrode.
21:8.0.1.1.25.2.1.6SECTION 876.1500
     876.1500 Endoscope and accessories.
21:8.0.1.1.25.2.1.7SECTION 876.1620
     876.1620 Urodynamics measurement system.
21:8.0.1.1.25.2.1.8SECTION 876.1725
     876.1725 Gastrointestinal motility monitoring system.
21:8.0.1.1.25.2.1.9SECTION 876.1735
     876.1735 Electrogastrography system.
21:8.0.1.1.25.2.1.10SECTION 876.1800
     876.1800 Urine flow or volume measuring system.
21:8.0.1.1.25.3SUBPART C
Subpart C - Monitoring Devices
21:8.0.1.1.25.3.1.1SECTION 876.2040
     876.2040 Enuresis alarm.
21:8.0.1.1.25.3.1.2SECTION 876.2050
     876.2050 Prostate lesion documentation system.
21:8.0.1.1.25.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.25.4.1.1SECTION 876.3350
     876.3350 Penile inflatable implant.
21:8.0.1.1.25.4.1.2SECTION 876.3500
     876.3500 Penile implant surgical accessories.
21:8.0.1.1.25.4.1.3SECTION 876.3630
     876.3630 Penile rigidity implant.
21:8.0.1.1.25.4.1.4SECTION 876.3750
     876.3750 Testicular prosthesis.
21:8.0.1.1.25.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.25.5.1.1SECTION 876.4020
     876.4020 Fiberoptic light ureteral catheter.
21:8.0.1.1.25.5.1.2SECTION 876.4270
     876.4270 Colostomy rod.
21:8.0.1.1.25.5.1.3SECTION 876.4300
     876.4300 Endoscopic electrosurgical unit and accessories.
21:8.0.1.1.25.5.1.4SECTION 876.4310
     876.4310 Endoscopic electrosurgical clip cutting system.
21:8.0.1.1.25.5.1.5SECTION 876.4340
     876.4340 High intensity ultrasound system for prostate tissue ablation.
21:8.0.1.1.25.5.1.6SECTION 876.4350
     876.4350 Fluid jet system for prostate tissue removal.
21:8.0.1.1.25.5.1.7SECTION 876.4370
     876.4370 Gastroenterology-urology evacuator.
21:8.0.1.1.25.5.1.8SECTION 876.4400
     876.4400 Hemorrhoidal ligator.
21:8.0.1.1.25.5.1.9SECTION 876.4480
     876.4480 Electrohydraulic lithotriptor.
21:8.0.1.1.25.5.1.10SECTION 876.4500
     876.4500 Mechanical lithotriptor.
21:8.0.1.1.25.5.1.11SECTION 876.4530
     876.4530 Gastroenterology-urology fiberoptic retractor.
21:8.0.1.1.25.5.1.12SECTION 876.4560
     876.4560 Ribdam.
21:8.0.1.1.25.5.1.13SECTION 876.4590
     876.4590 Interlocking urethral sound.
21:8.0.1.1.25.5.1.14SECTION 876.4620
     876.4620 Ureteral stent.
21:8.0.1.1.25.5.1.15SECTION 876.4630
     876.4630 Ureteral stent accessories.
21:8.0.1.1.25.5.1.16SECTION 876.4650
     876.4650 Water jet renal stone dislodger system.
21:8.0.1.1.25.5.1.17SECTION 876.4680
     876.4680 Ureteral stone dislodger.
21:8.0.1.1.25.5.1.18SECTION 876.4730
     876.4730 Manual gastroenterology-urology surgical instrument and accessories.
21:8.0.1.1.25.5.1.19SECTION 876.4770
     876.4770 Urethrotome.
21:8.0.1.1.25.5.1.20SECTION 876.4890
     876.4890 Urological table and accessories.
21:8.0.1.1.25.6SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.25.6.1.1SECTION 876.5010
     876.5010 Biliary catheter and accessories.
21:8.0.1.1.25.6.1.2SECTION 876.5011
     876.5011 Metallic biliary stent system for benign strictures.
21:8.0.1.1.25.6.1.3SECTION 876.5012
     876.5012 Biliary stent, drain, and dilator accessories.
21:8.0.1.1.25.6.1.4SECTION 876.5015
     876.5015 Pancreatic drainage stent and delivery system.
21:8.0.1.1.25.6.1.5SECTION 876.5020
     876.5020 External penile rigidity devices.
21:8.0.1.1.25.6.1.6SECTION 876.5025
     876.5025 Vibrator for climax control of premature ejaculation.
21:8.0.1.1.25.6.1.7SECTION 876.5030
     876.5030 Continent ileostomy catheter.
21:8.0.1.1.25.6.1.8SECTION 876.5090
     876.5090 Suprapubic urological catheter and accessories.
21:8.0.1.1.25.6.1.9SECTION 876.5100
     876.5100 Suprapubic catheter accessories.
21:8.0.1.1.25.6.1.10SECTION 876.5130
     876.5130 Urological catheter and accessories.
21:8.0.1.1.25.6.1.11SECTION 876.5140
     876.5140 Urethral insert with pump for bladder drainage.
21:8.0.1.1.25.6.1.12SECTION 876.5160
     876.5160 Urological clamp.
21:8.0.1.1.25.6.1.13SECTION 876.5210
     876.5210 Enema kit.
21:8.0.1.1.25.6.1.14SECTION 876.5220
     876.5220 Colonic irrigation system.
21:8.0.1.1.25.6.1.15SECTION 876.5250
     876.5250 Urine collector and accessories.
21:8.0.1.1.25.6.1.16SECTION 876.5270
     876.5270 Implanted electrical urinary continence device.
21:8.0.1.1.25.6.1.17SECTION 876.5280
     876.5280 Implanted mechanical/hydraulic urinary continence device.
21:8.0.1.1.25.6.1.18SECTION 876.5290
     876.5290 Implanted mechanical/hydraulic urinary continence device surgical accessories.
21:8.0.1.1.25.6.1.19SECTION 876.5310
     876.5310 Nonimplanted, peripheral electrical continence device.
21:8.0.1.1.25.6.1.20SECTION 876.5320
     876.5320 Nonimplanted electrical continence device.
21:8.0.1.1.25.6.1.21SECTION 876.5365
     876.5365 Esophageal dilator.
21:8.0.1.1.25.6.1.22SECTION 876.5450
     876.5450 Rectal dilator.
21:8.0.1.1.25.6.1.23SECTION 876.5470
     876.5470 Ureteral dilator.
21:8.0.1.1.25.6.1.24SECTION 876.5520
     876.5520 Urethral dilator.
21:8.0.1.1.25.6.1.25SECTION 876.5530
     876.5530 Implantable transprostatic tissue retractor system.
21:8.0.1.1.25.6.1.26SECTION 876.5540
     876.5540 Blood access device and accessories.
21:8.0.1.1.25.6.1.27SECTION 876.5550
     876.5550 Prostatic artery embolization device.
21:8.0.1.1.25.6.1.28SECTION 876.5600
     876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
21:8.0.1.1.25.6.1.29SECTION 876.5630
     876.5630 Peritoneal dialysis system and accessories.
21:8.0.1.1.25.6.1.30SECTION 876.5665
     876.5665 Water purification system for hemodialysis.
21:8.0.1.1.25.6.1.31SECTION 876.5820
     876.5820 Hemodialysis system and accessories.
21:8.0.1.1.25.6.1.32SECTION 876.5830
     876.5830 Hemodialyzer with disposable insert (Kiil type).
21:8.0.1.1.25.6.1.33SECTION 876.5860
     876.5860 High permeability hemodialysis system.
21:8.0.1.1.25.6.1.34SECTION 876.5870
     876.5870 Sorbent hemoperfusion system.
21:8.0.1.1.25.6.1.35SECTION 876.5880
     876.5880 Isolated kidney perfusion and transport system and accessories.
21:8.0.1.1.25.6.1.36SECTION 876.5885
     876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.
21:8.0.1.1.25.6.1.37SECTION 876.5895
     876.5895 Ostomy irrigator.
21:8.0.1.1.25.6.1.38SECTION 876.5900
     876.5900 Ostomy pouch and accessories.
21:8.0.1.1.25.6.1.39SECTION 876.5920
     876.5920 Protective garment for incontinence.
21:8.0.1.1.25.6.1.40SECTION 876.5930
     876.5930 Rectal control system.
21:8.0.1.1.25.6.1.41SECTION 876.5955
     876.5955 Peritoneo-venous shunt.
21:8.0.1.1.25.6.1.42SECTION 876.5970
     876.5970 Hernia support.
21:8.0.1.1.25.6.1.43SECTION 876.5980
     876.5980 Gastrointestinal tube and accessories.
21:8.0.1.1.25.6.1.44SECTION 876.5981
     876.5981 Oral removable palatal space occupying device for weight management and/or weight loss.
21:8.0.1.1.25.6.1.45SECTION 876.5985
     876.5985 Enzyme packed cartridge.
21:8.0.1.1.25.6.1.46SECTION 876.5990
     876.5990 Extracorporeal shock wave lithotripter.
21:8.0.1.1.26PART 878
PART 878 - GENERAL AND PLASTIC SURGERY DEVICES
21:8.0.1.1.26.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.26.1.1.1SECTION 878.1
     878.1 Scope.
21:8.0.1.1.26.1.1.2SECTION 878.3
     878.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.26.1.1.3SECTION 878.9
     878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.26.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.26.2.1.1SECTION 878.1800
     878.1800 Speculum and accessories.
21:8.0.1.1.26.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.26.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.26.4.1.1SECTION 878.3250
     878.3250 External facial fracture fixation appliance.
21:8.0.1.1.26.4.1.2SECTION 878.3300
     878.3300 Surgical mesh.
21:8.0.1.1.26.4.1.3SECTION 878.3500
     878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
21:8.0.1.1.26.4.1.4SECTION 878.3530
     878.3530 Silicone inflatable breast prosthesis.
21:8.0.1.1.26.4.1.5SECTION 878.3540
     878.3540 Silicone gel-filled breast prosthesis.
21:8.0.1.1.26.4.1.6SECTION 878.3550
     878.3550 Chin prosthesis.
21:8.0.1.1.26.4.1.7SECTION 878.3590
     878.3590 Ear prosthesis.
21:8.0.1.1.26.4.1.8SECTION 878.3610
     878.3610 Esophageal prosthesis.
21:8.0.1.1.26.4.1.9SECTION 878.3680
     878.3680 Nose prosthesis.
21:8.0.1.1.26.4.1.10SECTION 878.3720
     878.3720 Tracheal prosthesis.
21:8.0.1.1.26.4.1.11SECTION 878.3750
     878.3750 External prosthesis adhesive.
21:8.0.1.1.26.4.1.12SECTION 878.3800
     878.3800 External aesthetic restoration prosthesis.
21:8.0.1.1.26.4.1.13SECTION 878.3900
     878.3900 Inflatable extremity splint.
21:8.0.1.1.26.4.1.14SECTION 878.3910
     878.3910 Noninflatable extremity splint.
21:8.0.1.1.26.4.1.15SECTION 878.3925
     878.3925 Plastic surgery kit and accessories.
21:8.0.1.1.26.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.26.5.1.1SECTION 878.4010
     878.4010 Tissue adhesive.
21:8.0.1.1.26.5.1.2SECTION 878.4011
     878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
21:8.0.1.1.26.5.1.3SECTION 878.4014
     878.4014 Nonresorbable gauze/sponge for external use.
21:8.0.1.1.26.5.1.4SECTION 878.4015
     878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
21:8.0.1.1.26.5.1.5SECTION 878.4018
     878.4018 Hydrophilic wound dressing.
21:8.0.1.1.26.5.1.6SECTION 878.4020
     878.4020 Occlusive wound dressing.
21:8.0.1.1.26.5.1.7SECTION 878.4022
     878.4022 Hydrogel wound dressing and burn dressing.
21:8.0.1.1.26.5.1.8SECTION 878.4025
     878.4025 Silicone sheeting.
21:8.0.1.1.26.5.1.9SECTION 878.4040
     878.4040 Surgical apparel.
21:8.0.1.1.26.5.1.10SECTION 878.4100
     878.4100 Organ bag.
21:8.0.1.1.26.5.1.11SECTION 878.4160
     878.4160 Surgical camera and accessories.
21:8.0.1.1.26.5.1.12SECTION 878.4165
     878.4165 Wound autofluorescence imaging device.
21:8.0.1.1.26.5.1.13SECTION 878.4200
     878.4200 Introduction/drainage catheter and accessories.
21:8.0.1.1.26.5.1.14SECTION 878.4300
     878.4300 Implantable clip.
21:8.0.1.1.26.5.1.15SECTION 878.4320
     878.4320 Removable skin clip.
21:8.0.1.1.26.5.1.16SECTION 878.4340
     878.4340 Contact cooling system for aesthetic use.
21:8.0.1.1.26.5.1.17SECTION 878.4350
     878.4350 Cryosurgical unit and accessories.
21:8.0.1.1.26.5.1.18SECTION 878.4360
     878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
21:8.0.1.1.26.5.1.19SECTION 878.4370
     878.4370 Surgical drape and drape accessories.
21:8.0.1.1.26.5.1.20SECTION 878.4371
     878.4371 Irrigating wound retractor device.
21:8.0.1.1.26.5.1.21SECTION 878.4380
     878.4380 Drape adhesive.
21:8.0.1.1.26.5.1.22SECTION 878.4400
     878.4400 Electrosurgical cutting and coagulation device and accessories.
21:8.0.1.1.26.5.1.23SECTION 878.4410
     878.4410 Low energy ultrasound wound cleaner.
21:8.0.1.1.26.5.1.24SECTION 878.4420
     878.4420 Electrosurgical device for over-the-counter aesthetic use.
21:8.0.1.1.26.5.1.25SECTION 878.4430
     878.4430 Microneedling device for aesthetic use.
21:8.0.1.1.26.5.1.26SECTION 878.4440
     878.4440 Eye pad.
21:8.0.1.1.26.5.1.27SECTION 878.4450
     878.4450 Nonabsorbable gauze for internal use.
21:8.0.1.1.26.5.1.28SECTION 878.4452
     878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.
21:8.0.1.1.26.5.1.29SECTION 878.4454
     878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
21:8.0.1.1.26.5.1.30SECTION 878.4456
     878.4456 Hemostatic device for intraluminal gastrointestinal use.
21:8.0.1.1.26.5.1.31SECTION 878.4460
     878.4460 Non-powdered surgeon's glove.
21:8.0.1.1.26.5.1.32SECTION 878.4470
     878.4470 Surgeon's gloving cream.
21:8.0.1.1.26.5.1.33SECTION 878.4490
     878.4490 Absorbable hemostatic agent and dressing.
21:8.0.1.1.26.5.1.34SECTION 878.4493
     878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
21:8.0.1.1.26.5.1.35SECTION 878.4494
     878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
21:8.0.1.1.26.5.1.36SECTION 878.4495
     878.4495 Stainless steel suture.
21:8.0.1.1.26.5.1.37SECTION 878.4520
     878.4520 Polytetrafluoroethylene injectable.
21:8.0.1.1.26.5.1.38SECTION 878.4580
     878.4580 Surgical lamp.
21:8.0.1.1.26.5.1.39SECTION 878.4590
     878.4590 Focused ultrasound stimulator system for aesthetic use.
21:8.0.1.1.26.5.1.40SECTION 878.4630
     878.4630 Ultraviolet lamp for dermatologic disorders.
21:8.0.1.1.26.5.1.41SECTION 878.4635
     878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
21:8.0.1.1.26.5.1.42SECTION 878.4660
     878.4660 Skin marker.
21:8.0.1.1.26.5.1.43SECTION 878.4670
     878.4670 Internal tissue marker.
21:8.0.1.1.26.5.1.44SECTION 878.4680
     878.4680 Nonpowered, single patient, portable suction apparatus.
21:8.0.1.1.26.5.1.45SECTION 878.4683
     878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
21:8.0.1.1.26.5.1.46SECTION 878.4685
     878.4685 Extracorporeal shock wave device for treatment of chronic wounds.
21:8.0.1.1.26.5.1.47SECTION 878.4700
     878.4700 Surgical microscope and accessories.
21:8.0.1.1.26.5.1.48SECTION 878.4730
     878.4730 Surgical skin degreaser or adhesive tape solvent.
21:8.0.1.1.26.5.1.49SECTION 878.4750
     878.4750 Implantable staple.
21:8.0.1.1.26.5.1.50SECTION 878.4755
     878.4755 Absorbable lung biopsy plug.
21:8.0.1.1.26.5.1.51SECTION 878.4760
     878.4760 Removable skin staple.
21:8.0.1.1.26.5.1.52SECTION 878.4780
     878.4780 Powered suction pump.
21:8.0.1.1.26.5.1.53SECTION 878.4790
     878.4790 Powered surgical instrument for improvement in the appearance of cellulite.
21:8.0.1.1.26.5.1.54SECTION 878.4800
     878.4800 Manual surgical instrument for general use.
21:8.0.1.1.26.5.1.55SECTION 878.4810
     878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
21:8.0.1.1.26.5.1.56SECTION 878.4815
     878.4815 Magnetic surgical instrument system.
21:8.0.1.1.26.5.1.57SECTION 878.4820
     878.4820 Surgical instrument motors and accessories/attachments.
21:8.0.1.1.26.5.1.58SECTION 878.4830
     878.4830 Absorbable surgical gut suture.
21:8.0.1.1.26.5.1.59SECTION 878.4840
     878.4840 Absorbable polydioxanone surgical suture.
21:8.0.1.1.26.5.1.60SECTION 878.4860
     878.4860 Light based energy source device for topical application.
21:8.0.1.1.26.5.1.61SECTION 878.4930
     878.4930 Suture retention device.
21:8.0.1.1.26.5.1.62SECTION 878.4950
     878.4950 Manual operating table and accessories and manual operating chair and accessories.
21:8.0.1.1.26.5.1.63SECTION 878.4960
     878.4960 Operating tables and accessories and operating chairs and accessories.
21:8.0.1.1.26.5.1.64SECTION 878.5000
     878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
21:8.0.1.1.26.5.1.65SECTION 878.5010
     878.5010 Nonabsorbable polypropylene surgical suture.
21:8.0.1.1.26.5.1.66SECTION 878.5020
     878.5020 Nonabsorbable polyamide surgical suture.
21:8.0.1.1.26.5.1.67SECTION 878.5030
     878.5030 Natural nonabsorbable silk surgical suture.
21:8.0.1.1.26.5.1.68SECTION 878.5035
     878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
21:8.0.1.1.26.5.1.69SECTION 878.5040
     878.5040 Suction lipoplasty system.
21:8.0.1.1.26.5.1.70SECTION 878.5050
     878.5050 Surgical smoke precipitator.
21:8.0.1.1.26.6SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.26.6.1.1SECTION 878.5070
     878.5070 Air-handling apparatus for a surgical operating room.
21:8.0.1.1.26.6.1.2SECTION 878.5080
     878.5080 Air-handling apparatus accessory.
21:8.0.1.1.26.6.1.3SECTION 878.5350
     878.5350 Needle-type epilator.
21:8.0.1.1.26.6.1.4SECTION 878.5360
     878.5360 Tweezer-type epilator.
21:8.0.1.1.26.6.1.5SECTION 878.5400
     878.5400 Low level laser system for aesthetic use
21:8.0.1.1.26.6.1.6SECTION 878.5650
     878.5650 Topical oxygen chamber for extremities.
21:8.0.1.1.26.6.1.7SECTION 878.5900
     878.5900 Nonpneumatic tourniquet.
21:8.0.1.1.26.6.1.8SECTION 878.5910
     878.5910 Pneumatic tourniquet.
21:8.0.1.1.27PART 880
PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES
21:8.0.1.1.27.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.27.1.1.1SECTION 880.1
     880.1 Scope.
21:8.0.1.1.27.1.1.2SECTION 880.3
     880.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.27.1.1.3SECTION 880.9
     880.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.27.2SUBPART B
Subpart B [Reserved]
21:8.0.1.1.27.3SUBPART C
Subpart C - General Hospital and Personal Use Monitoring Devices
21:8.0.1.1.27.3.1.1SECTION 880.2200
     880.2200 Liquid crystal forehead temperature strip.
21:8.0.1.1.27.3.1.2SECTION 880.2400
     880.2400 Bed-patient monitor.
21:8.0.1.1.27.3.1.3SECTION 880.2420
     880.2420 Electronic monitor for gravity flow infusion systems.
21:8.0.1.1.27.3.1.4SECTION 880.2460
     880.2460 Electrically powered spinal fluid pressure monitor.
21:8.0.1.1.27.3.1.5SECTION 880.2500
     880.2500 Spinal fluid manometer.
21:8.0.1.1.27.3.1.6SECTION 880.2700
     880.2700 Stand-on patient scale.
21:8.0.1.1.27.3.1.7SECTION 880.2720
     880.2720 Patient scale.
21:8.0.1.1.27.3.1.8SECTION 880.2740
     880.2740 Surgical sponge scale.
21:8.0.1.1.27.3.1.9SECTION 880.2750
     880.2750 Image processing device for estimation of external blood loss.
21:8.0.1.1.27.3.1.10SECTION 880.2800
     880.2800 Sterilization process indicator.
21:8.0.1.1.27.3.1.11SECTION 880.2900
     880.2900 Clinical color change thermometer.
21:8.0.1.1.27.3.1.12SECTION 880.2910
     880.2910 Clinical electronic thermometer.
21:8.0.1.1.27.3.1.13SECTION 880.2920
     880.2920 Clinical mercury thermometer.
21:8.0.1.1.27.3.1.14SECTION 880.2930
     880.2930 Apgar timer.
21:8.0.1.1.27.4SUBPART D
Subparts D-E [Reserved]
21:8.0.1.1.27.5SUBPART F
Subpart F - General Hospital and Personal Use Therapeutic Devices
21:8.0.1.1.27.5.1.1SECTION 880.5025
     880.5025 I.V. container.
21:8.0.1.1.27.5.1.2SECTION 880.5045
     880.5045 Medical recirculating air cleaner.
21:8.0.1.1.27.5.1.3SECTION 880.5075
     880.5075 Elastic bandage.
21:8.0.1.1.27.5.1.4SECTION 880.5090
     880.5090 Liquid bandage.
21:8.0.1.1.27.5.1.5SECTION 880.5100
     880.5100 AC-powered adjustable hospital bed.
21:8.0.1.1.27.5.1.6SECTION 880.5110
     880.5110 Hydraulic adjustable hospital bed.
21:8.0.1.1.27.5.1.7SECTION 880.5120
     880.5120 Manual adjustable hospital bed.
21:8.0.1.1.27.5.1.8SECTION 880.5130
     880.5130 Infant radiant warmer.
21:8.0.1.1.27.5.1.9SECTION 880.5140
     880.5140 Pediatric medical crib.
21:8.0.1.1.27.5.1.10SECTION 880.5145
     880.5145 Medical bassinet.
21:8.0.1.1.27.5.1.11SECTION 880.5150
     880.5150 Nonpowered flotation therapy mattress.
21:8.0.1.1.27.5.1.12SECTION 880.5160
     880.5160 Therapeutic medical binder.
21:8.0.1.1.27.5.1.13SECTION 880.5180
     880.5180 Burn sheet.
21:8.0.1.1.27.5.1.14SECTION 880.5200
     880.5200 Intravascular catheter.
21:8.0.1.1.27.5.1.15SECTION 880.5210
     880.5210 Intravascular catheter securement device.
21:8.0.1.1.27.5.1.16SECTION 880.5240
     880.5240 Medical adhesive tape and adhesive bandage.
21:8.0.1.1.27.5.1.17SECTION 880.5270
     880.5270 Neonatal eye pad.
21:8.0.1.1.27.5.1.18SECTION 880.5300
     880.5300 Medical absorbent fiber.
21:8.0.1.1.27.5.1.19SECTION 880.5400
     880.5400 Neonatal incubator.
21:8.0.1.1.27.5.1.20SECTION 880.5410
     880.5410 Neonatal transport incubator.
21:8.0.1.1.27.5.1.21SECTION 880.5420
     880.5420 Pressure infusor for an I.V. bag.
21:8.0.1.1.27.5.1.22SECTION 880.5430
     880.5430 Nonelectrically powered fluid injector.
21:8.0.1.1.27.5.1.23SECTION 880.5440
     880.5440 Intravascular administration set.
21:8.0.1.1.27.5.1.24SECTION 880.5445
     880.5445 Intravascular administration set, automated air removal system.
21:8.0.1.1.27.5.1.25SECTION 880.5450
     880.5450 Patient care reverse isolation chamber.
21:8.0.1.1.27.5.1.26SECTION 880.5475
     880.5475 Jet lavage.
21:8.0.1.1.27.5.1.27SECTION 880.5500
     880.5500 AC-powered patient lift.
21:8.0.1.1.27.5.1.28SECTION 880.5510
     880.5510 Non-AC-powered patient lift.
21:8.0.1.1.27.5.1.29SECTION 880.5550
     880.5550 Alternating pressure air flotation mattress.
21:8.0.1.1.27.5.1.30SECTION 880.5560
     880.5560 Temperature regulated water mattress.
21:8.0.1.1.27.5.1.31SECTION 880.5570
     880.5570 Hypodermic single lumen needle.
21:8.0.1.1.27.5.1.32SECTION 880.5580
     880.5580 Acupuncture needle.
21:8.0.1.1.27.5.1.33SECTION 880.5630
     880.5630 Nipple shield.
21:8.0.1.1.27.5.1.34SECTION 880.5640
     880.5640 Lamb feeding nipple.
21:8.0.1.1.27.5.1.35SECTION 880.5680
     880.5680 Pediatric position holder.
21:8.0.1.1.27.5.1.36SECTION 880.5700
     880.5700 Neonatal phototherapy unit.
21:8.0.1.1.27.5.1.37SECTION 880.5725
     880.5725 Infusion pump.
21:8.0.1.1.27.5.1.38SECTION 880.5740
     880.5740 Suction snakebite kit.
21:8.0.1.1.27.5.1.39SECTION 880.5760
     880.5760 Chemical cold pack snakebite kit.
21:8.0.1.1.27.5.1.40SECTION 880.5780
     880.5780 Medical support stocking.
21:8.0.1.1.27.5.1.41SECTION 880.5820
     880.5820 Therapeutic scrotal support.
21:8.0.1.1.27.5.1.42SECTION 880.5860
     880.5860 Piston syringe.
21:8.0.1.1.27.5.1.43SECTION 880.5950
     880.5950 Umbilical occlusion device.
21:8.0.1.1.27.5.1.44SECTION 880.5960
     880.5960 Lice removal kit.
21:8.0.1.1.27.5.1.45SECTION 880.5965
     880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
21:8.0.1.1.27.5.1.46SECTION 880.5970
     880.5970 Percutaneous, implanted, long-term intravascular catheter.
21:8.0.1.1.27.6SUBPART G
Subpart G - General Hospital and Personal Use Miscellaneous Devices
21:8.0.1.1.27.6.1.1SECTION 880.6025
     880.6025 Absorbent tipped applicator.
21:8.0.1.1.27.6.1.2SECTION 880.6050
     880.6050 Ice bag.
21:8.0.1.1.27.6.1.3SECTION 880.6060
     880.6060 Medical disposable bedding.
21:8.0.1.1.27.6.1.4SECTION 880.6070
     880.6070 Bed board.
21:8.0.1.1.27.6.1.5SECTION 880.6080
     880.6080 Cardiopulmonary resuscitation board.
21:8.0.1.1.27.6.1.6SECTION 880.6085
     880.6085 Hot/cold water bottle.
21:8.0.1.1.27.6.1.7SECTION 880.6100
     880.6100 Ethylene oxide gas aerator cabinet.
21:8.0.1.1.27.6.1.8SECTION 880.6140
     880.6140 Medical chair and table.
21:8.0.1.1.27.6.1.9SECTION 880.6150
     880.6150 Ultrasonic cleaner for medical instruments.
21:8.0.1.1.27.6.1.10SECTION 880.6175
     880.6175 [Reserved]
21:8.0.1.1.27.6.1.11SECTION 880.6185
     880.6185 Cast cover.
21:8.0.1.1.27.6.1.12SECTION 880.6190
     880.6190 Mattress cover for medical purposes.
21:8.0.1.1.27.6.1.13SECTION 880.6200
     880.6200 Ring cutter.
21:8.0.1.1.27.6.1.14SECTION 880.6210
     880.6210 Sharps needle destruction device.
21:8.0.1.1.27.6.1.15SECTION 880.6230
     880.6230 Tongue depressor.
21:8.0.1.1.27.6.1.16SECTION 880.6250
     880.6250 Non-powdered patient examination glove.
21:8.0.1.1.27.6.1.17SECTION 880.6260
     880.6260 Filtering facepiece respirator for use by the general public in public health medical emergencies.
21:8.0.1.1.27.6.1.18SECTION 880.6265
     880.6265 Examination gown.
21:8.0.1.1.27.6.1.19SECTION 880.6280
     880.6280 Medical insole.
21:8.0.1.1.27.6.1.20SECTION 880.6300
     880.6300 Implantable radiofrequency transponder system for patient identification and health information.
21:8.0.1.1.27.6.1.21SECTION 880.6305
     880.6305 Ingestible event marker.
21:8.0.1.1.27.6.1.22SECTION 880.6310
     880.6310 Medical device data system.
21:8.0.1.1.27.6.1.23SECTION 880.6315
     880.6315 Remote Medication Management System.
21:8.0.1.1.27.6.1.24SECTION 880.6320
     880.6320 AC-powered medical examination light.
21:8.0.1.1.27.6.1.25SECTION 880.6350
     880.6350 Battery-powered medical examination light.
21:8.0.1.1.27.6.1.26SECTION 880.6375
     880.6375 Patient lubricant.
21:8.0.1.1.27.6.1.27SECTION 880.6430
     880.6430 Liquid medication dispenser.
21:8.0.1.1.27.6.1.28SECTION 880.6450
     880.6450 Skin pressure protectors.
21:8.0.1.1.27.6.1.29SECTION 880.6500
     880.6500 Medical ultraviolet air purifier.
21:8.0.1.1.27.6.1.30SECTION 880.6600
     880.6600 Ultraviolet (UV) radiation chamber disinfection device.
21:8.0.1.1.27.6.1.31SECTION 880.6710
     880.6710 Medical ultraviolet water purifier.
21:8.0.1.1.27.6.1.32SECTION 880.6730
     880.6730 Body waste receptacle.
21:8.0.1.1.27.6.1.33SECTION 880.6740
     880.6740 Vacuum-powered body fluid suction apparatus.
21:8.0.1.1.27.6.1.34SECTION 880.6760
     880.6760 Protective restraint.
21:8.0.1.1.27.6.1.35SECTION 880.6775
     880.6775 Powered patient transfer device.
21:8.0.1.1.27.6.1.36SECTION 880.6785
     880.6785 Manual patient transfer device.
21:8.0.1.1.27.6.1.37SECTION 880.6800
     880.6800 Washers for body waste receptacles.
21:8.0.1.1.27.6.1.38SECTION 880.6820
     880.6820 Medical disposable scissors.
21:8.0.1.1.27.6.1.39SECTION 880.6850
     880.6850 Sterilization wrap.
21:8.0.1.1.27.6.1.40SECTION 880.6860
     880.6860 Ethylene oxide gas sterilizer.
21:8.0.1.1.27.6.1.41SECTION 880.6870
     880.6870 Dry-heat sterilizer.
21:8.0.1.1.27.6.1.42SECTION 880.6880
     880.6880 Steam sterilizer.
21:8.0.1.1.27.6.1.43SECTION 880.6885
     880.6885 Liquid chemical sterilants/high level disinfectants.
21:8.0.1.1.27.6.1.44SECTION 880.6890
     880.6890 General purpose disinfectants.
21:8.0.1.1.27.6.1.45SECTION 880.6900
     880.6900 Hand-carried stretcher.
21:8.0.1.1.27.6.1.46SECTION 880.6910
     880.6910 Wheeled stretcher.
21:8.0.1.1.27.6.1.47SECTION 880.6920
     880.6920 Syringe needle introducer.
21:8.0.1.1.27.6.1.48SECTION 880.6960
     880.6960 Irrigating syringe.
21:8.0.1.1.27.6.1.49SECTION 880.6970
     880.6970 Liquid crystal vein locator.
21:8.0.1.1.27.6.1.50SECTION 880.6980
     880.6980 Vein stabilizer.
21:8.0.1.1.27.6.1.51SECTION 880.6990
     880.6990 Infusion stand.
21:8.0.1.1.27.6.1.52SECTION 880.6991
     880.6991 Medical washer.
21:8.0.1.1.27.6.1.53SECTION 880.6992
     880.6992 Medical washer-disinfector.
21:8.0.1.1.28PART 882
PART 882 - NEUROLOGICAL DEVICES
21:8.0.1.1.28.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.28.1.1.1SECTION 882.1
     882.1 Scope.
21:8.0.1.1.28.1.1.2SECTION 882.3
     882.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.28.1.1.3SECTION 882.9
     882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.28.2SUBPART B
Subpart B - Neurological Diagnostic Devices
21:8.0.1.1.28.2.1.1SECTION 882.1020
     882.1020 Rigidity analyzer.
21:8.0.1.1.28.2.1.2SECTION 882.1030
     882.1030 Ataxiagraph.
21:8.0.1.1.28.2.1.3SECTION 882.1200
     882.1200 Two-point discriminator.
21:8.0.1.1.28.2.1.4SECTION 882.1240
     882.1240 Echoencephalograph.
21:8.0.1.1.28.2.1.5SECTION 882.1275
     882.1275 Electroconductive media.
21:8.0.1.1.28.2.1.6SECTION 882.1310
     882.1310 Cortical electrode.
21:8.0.1.1.28.2.1.7SECTION 882.1320
     882.1320 Cutaneous electrode.
21:8.0.1.1.28.2.1.8SECTION 882.1330
     882.1330 Depth electrode.
21:8.0.1.1.28.2.1.9SECTION 882.1340
     882.1340 Nasopharyngeal electrode.
21:8.0.1.1.28.2.1.10SECTION 882.1350
     882.1350 Needle electrode.
21:8.0.1.1.28.2.1.11SECTION 882.1400
     882.1400 Electroencephalograph.
21:8.0.1.1.28.2.1.12SECTION 882.1410
     882.1410 Electroencephalograph electrode/lead tester.
21:8.0.1.1.28.2.1.13SECTION 882.1420
     882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
21:8.0.1.1.28.2.1.14SECTION 882.1430
     882.1430 Electroencephalograph test signal generator.
21:8.0.1.1.28.2.1.15SECTION 882.1440
     882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid.
21:8.0.1.1.28.2.1.16SECTION 882.1450
     882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.
21:8.0.1.1.28.2.1.17SECTION 882.1460
     882.1460 Nystagmograph.
21:8.0.1.1.28.2.1.18SECTION 882.1470
     882.1470 Computerized cognitive assessment aid.
21:8.0.1.1.28.2.1.19SECTION 882.1471
     882.1471 Computerized cognitive assessment aid for concussion.
21:8.0.1.1.28.2.1.20SECTION 882.1480
     882.1480 Neurological endoscope.
21:8.0.1.1.28.2.1.21SECTION 882.1500
     882.1500 Esthesiometer.
21:8.0.1.1.28.2.1.22SECTION 882.1525
     882.1525 Tuning fork.
21:8.0.1.1.28.2.1.23SECTION 882.1540
     882.1540 Galvanic skin response measurement device.
21:8.0.1.1.28.2.1.24SECTION 882.1550
     882.1550 Nerve conduction velocity measurement device.
21:8.0.1.1.28.2.1.25SECTION 882.1560
     882.1560 Skin potential measurement device.
21:8.0.1.1.28.2.1.26SECTION 882.1561
     882.1561 Evoked photon image capture device.
21:8.0.1.1.28.2.1.27SECTION 882.1570
     882.1570 Powered direct-contact temperature measurement device.
21:8.0.1.1.28.2.1.28SECTION 882.1580
     882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
21:8.0.1.1.28.2.1.29SECTION 882.1610
     882.1610 Alpha monitor.
21:8.0.1.1.28.2.1.30SECTION 882.1620
     882.1620 Intracranial pressure monitoring device.
21:8.0.1.1.28.2.1.31SECTION 882.1630
     882.1630 Cranial motion measurement device.
21:8.0.1.1.28.2.1.32SECTION 882.1700
     882.1700 Percussor.
21:8.0.1.1.28.2.1.33SECTION 882.1750
     882.1750 Pinwheel.
21:8.0.1.1.28.2.1.34SECTION 882.1790
     882.1790 Ocular plethysmograph.
21:8.0.1.1.28.2.1.35SECTION 882.1825
     882.1825 Rheoencephalograph.
21:8.0.1.1.28.2.1.36SECTION 882.1835
     882.1835 Physiological signal amplifier.
21:8.0.1.1.28.2.1.37SECTION 882.1845
     882.1845 Physiological signal conditioner.
21:8.0.1.1.28.2.1.38SECTION 882.1855
     882.1855 Electroencephalogram (EEG) telemetry system.
21:8.0.1.1.28.2.1.39SECTION 882.1870
     882.1870 Evoked response electrical stimulator.
21:8.0.1.1.28.2.1.40SECTION 882.1880
     882.1880 Evoked response mechanical stimulator.
21:8.0.1.1.28.2.1.41SECTION 882.1890
     882.1890 Evoked response photic stimulator.
21:8.0.1.1.28.2.1.42SECTION 882.1900
     882.1900 Evoked response auditory stimulator.
21:8.0.1.1.28.2.1.43SECTION 882.1925
     882.1925 Ultrasonic scanner calibration test block.
21:8.0.1.1.28.2.1.44SECTION 882.1935
     882.1935 Near Infrared (NIR) Brain Hematoma Detector.
21:8.0.1.1.28.2.1.45SECTION 882.1950
     882.1950 Tremor transducer.
21:8.0.1.1.28.3SUBPART C
Subparts C-D [Reserved]
21:8.0.1.1.28.4SUBPART E
Subpart E - Neurological Surgical Devices
21:8.0.1.1.28.4.1.1SECTION 882.4030
     882.4030 Skull plate anvil.
21:8.0.1.1.28.4.1.2SECTION 882.4060
     882.4060 Ventricular cannula.
21:8.0.1.1.28.4.1.3SECTION 882.4100
     882.4100 Ventricular catheter.
21:8.0.1.1.28.4.1.4SECTION 882.4125
     882.4125 Neurosurgical chair.
21:8.0.1.1.28.4.1.5SECTION 882.4150
     882.4150 Scalp clip.
21:8.0.1.1.28.4.1.6SECTION 882.4175
     882.4175 Aneurysm clip applier.
21:8.0.1.1.28.4.1.7SECTION 882.4190
     882.4190 Clip forming/cutting instrument.
21:8.0.1.1.28.4.1.8SECTION 882.4200
     882.4200 Clip removal instrument.
21:8.0.1.1.28.4.1.9SECTION 882.4215
     882.4215 Clip rack.
21:8.0.1.1.28.4.1.10SECTION 882.4250
     882.4250 Cryogenic surgical device.
21:8.0.1.1.28.4.1.11SECTION 882.4275
     882.4275 Dowel cutting instrument.
21:8.0.1.1.28.4.1.12SECTION 882.4300
     882.4300 Manual cranial drills, burrs, trephines, and their accessories
21:8.0.1.1.28.4.1.13SECTION 882.4305
     882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
21:8.0.1.1.28.4.1.14SECTION 882.4310
     882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
21:8.0.1.1.28.4.1.15SECTION 882.4325
     882.4325 Cranial drill handpiece (brace).
21:8.0.1.1.28.4.1.16SECTION 882.4360
     882.4360 Electric cranial drill motor.
21:8.0.1.1.28.4.1.17SECTION 882.4370
     882.4370 Pneumatic cranial drill motor.
21:8.0.1.1.28.4.1.18SECTION 882.4400
     882.4400 Radiofrequency lesion generator.
21:8.0.1.1.28.4.1.19SECTION 882.4440
     882.4440 Neurosurgical headrests.
21:8.0.1.1.28.4.1.20SECTION 882.4460
     882.4460 Neurosurgical head holder (skull clamp).
21:8.0.1.1.28.4.1.21SECTION 882.4500
     882.4500 Cranioplasty material forming instrument.
21:8.0.1.1.28.4.1.22SECTION 882.4525
     882.4525 Microsurgical instrument.
21:8.0.1.1.28.4.1.23SECTION 882.4535
     882.4535 Nonpowered neurosurgical instrument.
21:8.0.1.1.28.4.1.24SECTION 882.4545
     882.4545 Shunt system implantation instrument.
21:8.0.1.1.28.4.1.25SECTION 882.4560
     882.4560 Stereotaxic instrument.
21:8.0.1.1.28.4.1.26SECTION 882.4600
     882.4600 Leukotome.
21:8.0.1.1.28.4.1.27SECTION 882.4650
     882.4650 Neurosurgical suture needle.
21:8.0.1.1.28.4.1.28SECTION 882.4700
     882.4700 Neurosurgical paddie.
21:8.0.1.1.28.4.1.29SECTION 882.4725
     882.4725 Radiofrequency lesion probe.
21:8.0.1.1.28.4.1.30SECTION 882.4750
     882.4750 Skull punch.
21:8.0.1.1.28.4.1.31SECTION 882.4800
     882.4800 Self-retaining retractor for neurosurgery.
21:8.0.1.1.28.4.1.32SECTION 882.4840
     882.4840 Manual rongeur.
21:8.0.1.1.28.4.1.33SECTION 882.4845
     882.4845 Powered rongeur.
21:8.0.1.1.28.4.1.34SECTION 882.4900
     882.4900 Skullplate screwdriver.
21:8.0.1.1.28.5SUBPART F
Subpart F - Neurological Therapeutic Devices
21:8.0.1.1.28.5.1.1SECTION 882.5030
     882.5030 Methyl methacrylate for aneurysmorrhaphy.
21:8.0.1.1.28.5.1.2SECTION 882.5050
     882.5050 Biofeedback device.
21:8.0.1.1.28.5.1.3SECTION 882.5070
     882.5070 Bite block.
21:8.0.1.1.28.5.1.4SECTION 882.5150
     882.5150 Intravascular occluding catheter.
21:8.0.1.1.28.5.1.5SECTION 882.5175
     882.5175 Carotid artery clamp.
21:8.0.1.1.28.5.1.6SECTION 882.5200
     882.5200 Aneurysm clip.
21:8.0.1.1.28.5.1.7SECTION 882.5225
     882.5225 Implanted malleable clip.
21:8.0.1.1.28.5.1.8SECTION 882.5235
     882.5235 Aversive conditioning device.
21:8.0.1.1.28.5.1.9SECTION 882.5250
     882.5250 Burr hole cover.
21:8.0.1.1.28.5.1.10SECTION 882.5275
     882.5275 Nerve cuff.
21:8.0.1.1.28.5.1.11SECTION 882.5300
     882.5300 Methyl methacrylate for cranioplasty.
21:8.0.1.1.28.5.1.12SECTION 882.5320
     882.5320 Preformed alterable cranioplasty plate.
21:8.0.1.1.28.5.1.13SECTION 882.5330
     882.5330 Preformed nonalterable cranioplasty plate.
21:8.0.1.1.28.5.1.14SECTION 882.5360
     882.5360 Cranioplasty plate fastener.
21:8.0.1.1.28.5.1.15SECTION 882.5500
     882.5500 Lesion temperature monitor.
21:8.0.1.1.28.5.1.16SECTION 882.5550
     882.5550 Central nervous system fluid shunt and components.
21:8.0.1.1.28.5.1.17SECTION 882.5600
     882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
21:8.0.1.1.28.5.1.18SECTION 882.5700
     882.5700 Thermal system for insomnia.
21:8.0.1.1.28.5.1.19SECTION 882.5800
     882.5800 Cranial electrotherapy stimulator.
21:8.0.1.1.28.5.1.20SECTION 882.5801
     882.5801 Computerized behavioral therapy device for psychiatric disorders.
21:8.0.1.1.28.5.1.21SECTION 882.5802
     882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
21:8.0.1.1.28.5.1.22SECTION 882.5805
     882.5805 Repetitive transcranial magnetic stimulation system.
21:8.0.1.1.28.5.1.23SECTION 882.5808
     882.5808 Transcranial magnetic stimulator for headache.
21:8.0.1.1.28.5.1.24SECTION 882.5810
     882.5810 External functional neuromuscular stimulator.
21:8.0.1.1.28.5.1.25SECTION 882.5820
     882.5820 Implanted cerebellar stimulator.
21:8.0.1.1.28.5.1.26SECTION 882.5830
     882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
21:8.0.1.1.28.5.1.27SECTION 882.5840
     882.5840 Implanted intracerebral/subcortical stimulator for pain relief.
21:8.0.1.1.28.5.1.28SECTION 882.5850
     882.5850 Implanted spinal cord stimulator for bladder evacuation.
21:8.0.1.1.28.5.1.29SECTION 882.5860
     882.5860 Implanted neuromuscular stimulator.
21:8.0.1.1.28.5.1.30SECTION 882.5870
     882.5870 Implanted peripheral nerve stimulator for pain relief.
21:8.0.1.1.28.5.1.31SECTION 882.5880
     882.5880 Implanted spinal cord stimulator for pain relief.
21:8.0.1.1.28.5.1.32SECTION 882.5890
     882.5890 Transcutaneous electrical nerve stimulator for pain relief.
21:8.0.1.1.28.5.1.33SECTION 882.5891
     882.5891 Transcutaneous electrical nerve stimulator to treat headache.
21:8.0.1.1.28.5.1.34SECTION 882.5892
     882.5892 External vagal nerve stimulator for headache.
21:8.0.1.1.28.5.1.35SECTION 882.5893
     882.5893 Thermal vestibular stimulator for headache.
21:8.0.1.1.28.5.1.36SECTION 882.5894
     882.5894 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
21:8.0.1.1.28.5.1.37SECTION 882.5895
     882.5895 Vibratory counter-stimulation device.
21:8.0.1.1.28.5.1.38SECTION 882.5896
     882.5896 Percutaneous nerve stimulator for substance use disorders.
21:8.0.1.1.28.5.1.39SECTION 882.5900
     882.5900 Preformed craniosynostosis strip.
21:8.0.1.1.28.5.1.40SECTION 882.5897
     882.5897 External upper limb tremor stimulator.
21:8.0.1.1.28.5.1.41SECTION 882.5910
     882.5910 Dura substitute.
21:8.0.1.1.28.5.1.42SECTION 882.5940
     882.5940 Electroconvulsive therapy device.
21:8.0.1.1.28.5.1.43SECTION 882.5950
     882.5950 Neurovascular embolization device.
21:8.0.1.1.28.5.1.44SECTION 882.5960
     882.5960 Skull tongs for traction.
21:8.0.1.1.28.5.1.45SECTION 882.5970
     882.5970 Cranial orthosis.
21:8.0.1.1.28.5.1.46SECTION 882.5975
     882.5975 Human dura mater.
21:8.0.1.1.29PART 884
PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES
21:8.0.1.1.29.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.29.1.1.1SECTION 884.1
     884.1 Scope.
21:8.0.1.1.29.1.1.2SECTION 884.3
     884.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.29.1.1.3SECTION 884.9
     884.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.29.2SUBPART B
Subpart B - Obstetrical and Gynecological Diagnostic Devices
21:8.0.1.1.29.2.1.1SECTION 884.1040
     884.1040 Viscometer for cervical mucus.
21:8.0.1.1.29.2.1.2SECTION 884.1050
     884.1050 Endocervical aspirator.
21:8.0.1.1.29.2.1.3SECTION 884.1060
     884.1060 Endometrial aspirator.
21:8.0.1.1.29.2.1.4SECTION 884.1100
     884.1100 Endometrial brush.
21:8.0.1.1.29.2.1.5SECTION 884.1175
     884.1175 Endometrial suction curette and accessories.
21:8.0.1.1.29.2.1.6SECTION 884.1185
     884.1185 Endometrial washer.
21:8.0.1.1.29.2.1.7SECTION 884.1300
     884.1300 Uterotubal carbon dioxide insufflator and accessories.
21:8.0.1.1.29.2.1.8SECTION 884.1425
     884.1425 Perineometer.
21:8.0.1.1.29.2.1.9SECTION 884.1550
     884.1550 Amniotic fluid sampler (amniocentesis tray).
21:8.0.1.1.29.2.1.10SECTION 884.1560
     884.1560 Fetal blood sampler.
21:8.0.1.1.29.2.1.11SECTION 884.1600
     884.1600 Transabdominal amnioscope (fetoscope) and accessories.
21:8.0.1.1.29.2.1.12SECTION 884.1630
     884.1630 Colposcope.
21:8.0.1.1.29.2.1.13SECTION 884.1640
     884.1640 Culdoscope and accessories.
21:8.0.1.1.29.2.1.14SECTION 884.1660
     884.1660 Transcervical endoscope (amnioscope) and accessories.
21:8.0.1.1.29.2.1.15SECTION 884.1690
     884.1690 Hysteroscope and accessories.
21:8.0.1.1.29.2.1.16SECTION 884.1700
     884.1700 Hysteroscopic insufflator.
21:8.0.1.1.29.2.1.17SECTION 884.1710
     884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator.
21:8.0.1.1.29.2.1.18SECTION 884.1720
     884.1720 Gynecologic laparoscope and accessories.
21:8.0.1.1.29.2.1.19SECTION 884.1730
     884.1730 Laparoscopic insufflator.
21:8.0.1.1.29.3SUBPART C
Subpart C - Obstetrical and Gynecological Monitoring Devices
21:8.0.1.1.29.3.1.1SECTION 884.2050
     884.2050 Obstetric data analyzer.
21:8.0.1.1.29.3.1.2SECTION 884.2225
     884.2225 Obstetric-gynecologic ultrasonic imager.
21:8.0.1.1.29.3.1.3SECTION 884.2600
     884.2600 Fetal cardiac monitor.
21:8.0.1.1.29.3.1.4SECTION 884.2620
     884.2620 Fetal electroencephalographic monitor.
21:8.0.1.1.29.3.1.5SECTION 884.2640
     884.2640 Fetal phonocardiographic monitor and accessories.
21:8.0.1.1.29.3.1.6SECTION 884.2660
     884.2660 Fetal ultrasonic monitor and accessories.
21:8.0.1.1.29.3.1.7SECTION 884.2675
     884.2675 Fetal scalp circular (spiral) electrode and applicator.
21:8.0.1.1.29.3.1.8SECTION 884.2685
     884.2685 Fetal scalp clip electrode and applicator.
21:8.0.1.1.29.3.1.9SECTION 884.2700
     884.2700 Intrauterine pressure monitor and accessories.
21:8.0.1.1.29.3.1.10SECTION 884.2720
     884.2720 External uterine contraction monitor and accessories.
21:8.0.1.1.29.3.1.11SECTION 884.2730
     884.2730 Home uterine activity monitor.
21:8.0.1.1.29.3.1.12SECTION 884.2740
     884.2740 Perinatal monitoring system and accessories.
21:8.0.1.1.29.3.1.13SECTION 884.2800
     884.2800 Computerized Labor Monitoring System.
21:8.0.1.1.29.3.1.14SECTION 884.2900
     884.2900 Fetal stethoscope.
21:8.0.1.1.29.3.1.15SECTION 884.2960
     884.2960 Obstetric ultrasonic transducer and accessories.
21:8.0.1.1.29.3.1.16SECTION 884.2980
     884.2980 Telethermographic system.
21:8.0.1.1.29.3.1.17SECTION 884.2982
     884.2982 Liquid crystal thermographic system.
21:8.0.1.1.29.3.1.18SECTION 884.2990
     884.2990 Breast lesion documentation system.
21:8.0.1.1.29.4SUBPART D
Subpart D - Obstetrical and Gynecological Prosthetic Devices
21:8.0.1.1.29.4.1.1SECTION 884.3200
     884.3200 Cervical drain.
21:8.0.1.1.29.4.1.2SECTION 884.3575
     884.3575 Vaginal pessary.
21:8.0.1.1.29.4.1.3SECTION 884.3650
     884.3650 Fallopian tube prosthesis.
21:8.0.1.1.29.4.1.4SECTION 884.3900
     884.3900 Vaginal stent.
21:8.0.1.1.29.5SUBPART E
Subpart E - Obstetrical and Gynecological Surgical Devices
21:8.0.1.1.29.5.1.1SECTION 884.4050
     884.4050 Gynecologic laparoscopic power morcellation containment system.
21:8.0.1.1.29.5.1.2SECTION 884.4100
     884.4100 Endoscopic electrocautery and accessories.
21:8.0.1.1.29.5.1.3SECTION 884.4120
     884.4120 Gynecologic electrocautery and accessories.
21:8.0.1.1.29.5.1.4SECTION 884.4150
     884.4150 Bipolar endoscopic coagulator-cutter and accessories.
21:8.0.1.1.29.5.1.5SECTION 884.4160
     884.4160 Unipolar endoscopic coagulator-cutter and accessories.
21:8.0.1.1.29.5.1.6SECTION 884.4250
     884.4250 Expandable cervical dilator.
21:8.0.1.1.29.5.1.7SECTION 884.4260
     884.4260 Hygroscopic Laminaria cervical dilator.
21:8.0.1.1.29.5.1.8SECTION 884.4270
     884.4270 Vibratory cervical dilators.
21:8.0.1.1.29.5.1.9SECTION 884.4340
     884.4340 Fetal vacuum extractor.
21:8.0.1.1.29.5.1.10SECTION 884.4350
     884.4350 Fetal head elevator.
21:8.0.1.1.29.5.1.11SECTION 884.4400
     884.4400 Obstetric forceps.
21:8.0.1.1.29.5.1.12SECTION 884.4500
     884.4500 Obstetric fetal destructive instrument.
21:8.0.1.1.29.5.1.13SECTION 884.4520
     884.4520 Obstetric-gynecologic general manual instrument.
21:8.0.1.1.29.5.1.14SECTION 884.4530
     884.4530 Obstetric-gynecologic specialized manual instrument.
21:8.0.1.1.29.5.1.15SECTION 884.4550
     884.4550 Gynecologic surgical laser.
21:8.0.1.1.29.5.1.16SECTION 884.4900
     884.4900 Obstetric table and accessories.
21:8.0.1.1.29.5.1.17SECTION 884.4910
     884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.
21:8.0.1.1.29.6SUBPART F
Subpart F - Obstetrical and Gynecological Therapeutic Devices
21:8.0.1.1.29.6.1.1SECTION 884.5050
     884.5050 Metreurynter-balloon abortion system.
21:8.0.1.1.29.6.1.2SECTION 884.5070
     884.5070 Vacuum abortion system.
21:8.0.1.1.29.6.1.3SECTION 884.5100
     884.5100 Obstetric anesthesia set.
21:8.0.1.1.29.6.1.4SECTION 884.5150
     884.5150 Nonpowered breast pump.
21:8.0.1.1.29.6.1.5SECTION 884.5160
     884.5160 Powered breast pump.
21:8.0.1.1.29.6.1.6SECTION 884.5200
     884.5200 Hemorrhoid prevention pressure wedge.
21:8.0.1.1.29.6.1.7SECTION 884.5210
     884.5210 Pressure wedge for the reduction of cesarean delivery.
21:8.0.1.1.29.6.1.8SECTION 884.5225
     884.5225 Abdominal decompression chamber.
21:8.0.1.1.29.6.1.9SECTION 884.5250
     884.5250 Cervical cap.
21:8.0.1.1.29.6.1.10SECTION 884.5300
     884.5300 Condom.
21:8.0.1.1.29.6.1.11SECTION 884.5310
     884.5310 Condom with spermicidal lubricant.
21:8.0.1.1.29.6.1.12SECTION 884.5320
     884.5320 Glans sheath.
21:8.0.1.1.29.6.1.13SECTION 884.5330
     884.5330 Multiple-use female condom.
21:8.0.1.1.29.6.1.14SECTION 884.5340
     884.5340 Single-use internal condom.
21:8.0.1.1.29.6.1.15SECTION 884.5350
     884.5350 Contraceptive diaphragm and accessories.
21:8.0.1.1.29.6.1.16SECTION 884.5360
     884.5360 Contraceptive intrauterine device (IUD) and introducer.
21:8.0.1.1.29.6.1.17SECTION 884.5370
     884.5370 Software application for contraception.
21:8.0.1.1.29.6.1.18SECTION 884.5380
     884.5380 Contraceptive tubal occlusion device (TOD) and introducer.
21:8.0.1.1.29.6.1.19SECTION 884.5390
     884.5390 Perineal heater.
21:8.0.1.1.29.6.1.20SECTION 884.5400
     884.5400 Menstrual cup.
21:8.0.1.1.29.6.1.21SECTION 884.5425
     884.5425 Scented or scented deodorized menstrual pad.
21:8.0.1.1.29.6.1.22SECTION 884.5435
     884.5435 Unscented menstrual pad.
21:8.0.1.1.29.6.1.23SECTION 884.5460
     884.5460 Scented or scented deodorized menstrual tampon.
21:8.0.1.1.29.6.1.24SECTION 884.5470
     884.5470 Unscented menstrual tampon.
21:8.0.1.1.29.6.1.25SECTION 884.5900
     884.5900 Therapeutic vaginal douche apparatus.
21:8.0.1.1.29.6.1.26SECTION 884.5920
     884.5920 Vaginal insufflator.
21:8.0.1.1.29.6.1.27SECTION 884.5940
     884.5940 Powered vaginal muscle stimulator for therapeutic use.
21:8.0.1.1.29.6.1.28SECTION 884.5960
     884.5960 Genital vibrator for therapeutic use.
21:8.0.1.1.29.6.1.29SECTION 884.5970
     884.5970 Clitoral engorgement device.
21:8.0.1.1.29.6.1.30SECTION 884.5980
     884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
21:8.0.1.1.29.7SUBPART G
Subpart G - Assisted Reproduction Devices
21:8.0.1.1.29.7.1.1SECTION 884.6100
     884.6100 Assisted reproduction needles.
21:8.0.1.1.29.7.1.2SECTION 884.6110
     884.6110 Assisted reproduction catheters.
21:8.0.1.1.29.7.1.3SECTION 884.6120
     884.6120 Assisted reproduction accessories.
21:8.0.1.1.29.7.1.4SECTION 884.6130
     884.6130 Assisted reproduction microtools.
21:8.0.1.1.29.7.1.5SECTION 884.6140
     884.6140 Assisted reproduction micropipette fabrication instruments.
21:8.0.1.1.29.7.1.6SECTION 884.6150
     884.6150 Assisted reproduction micromanipulators and microinjectors.
21:8.0.1.1.29.7.1.7SECTION 884.6160
     884.6160 Assisted reproduction labware.
21:8.0.1.1.29.7.1.8SECTION 884.6165
     884.6165 Intravaginal culture system.
21:8.0.1.1.29.7.1.9SECTION 884.6170
     884.6170 Assisted reproduction water and water purification systems.
21:8.0.1.1.29.7.1.10SECTION 884.6180
     884.6180 Reproductive media and supplements.
21:8.0.1.1.29.7.1.11SECTION 884.6190
     884.6190 Assisted reproductive microscopes and microscope accessories.
21:8.0.1.1.29.7.1.12SECTION 884.6195
     884.6195 Assisted Reproduction Embryo Image Assessment System.
21:8.0.1.1.29.7.1.13SECTION 884.6200
     884.6200 Assisted reproduction laser system.
21:8.0.1.1.30PART 886
PART 886 - OPHTHALMIC DEVICES
21:8.0.1.1.30.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.30.1.1.1SECTION 886.1
     886.1 Scope.
21:8.0.1.1.30.1.1.2SECTION 886.3
     886.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.30.1.1.3SECTION 886.9
     886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.30.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.30.2.1.1SECTION 886.1040
     886.1040 Ocular esthesiometer.
21:8.0.1.1.30.2.1.2SECTION 886.1050
     886.1050 Adaptometer (biophotometer).
21:8.0.1.1.30.2.1.3SECTION 886.1070
     886.1070 Anomaloscope.
21:8.0.1.1.30.2.1.4SECTION 886.1090
     886.1090 Haidinger brush.
21:8.0.1.1.30.2.1.5SECTION 886.1120
     886.1120 Ophthalmic camera.
21:8.0.1.1.30.2.1.6SECTION 886.1140
     886.1140 Ophthalmic chair.
21:8.0.1.1.30.2.1.7SECTION 886.1150
     886.1150 Visual acuity chart.
21:8.0.1.1.30.2.1.8SECTION 886.1160
     886.1160 Color vision plate illuminator.
21:8.0.1.1.30.2.1.9SECTION 886.1170
     886.1170 Color vision tester.
21:8.0.1.1.30.2.1.10SECTION 886.1190
     886.1190 Distometer.
21:8.0.1.1.30.2.1.11SECTION 886.1200
     886.1200 Optokinetic drum.
21:8.0.1.1.30.2.1.12SECTION 886.1220
     886.1220 Corneal electrode.
21:8.0.1.1.30.2.1.13SECTION 886.1250
     886.1250 Euthyscope.
21:8.0.1.1.30.2.1.14SECTION 886.1270
     886.1270 Exophthalmometer.
21:8.0.1.1.30.2.1.15SECTION 886.1290
     886.1290 Fixation device.
21:8.0.1.1.30.2.1.16SECTION 886.1300
     886.1300 Afterimage flasher.
21:8.0.1.1.30.2.1.17SECTION 886.1320
     886.1320 Fornixscope.
21:8.0.1.1.30.2.1.18SECTION 886.1330
     886.1330 Amsler grid.
21:8.0.1.1.30.2.1.19SECTION 886.1340
     886.1340 Haploscope.
21:8.0.1.1.30.2.1.20SECTION 886.1342
     886.1342 Strabismus detection device.
21:8.0.1.1.30.2.1.21SECTION 886.1350
     886.1350 Keratoscope.
21:8.0.1.1.30.2.1.22SECTION 886.1360
     886.1360 Visual field laser instrument.
21:8.0.1.1.30.2.1.23SECTION 886.1375
     886.1375 Bagolini lens.
21:8.0.1.1.30.2.1.24SECTION 886.1380
     886.1380 Diagnostic condensing lens.
21:8.0.1.1.30.2.1.25SECTION 886.1385
     886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
21:8.0.1.1.30.2.1.26SECTION 886.1390
     886.1390 Flexible diagnostic Fresnel lens.
21:8.0.1.1.30.2.1.27SECTION 886.1395
     886.1395 Diagnostic Hruby fundus lens.
21:8.0.1.1.30.2.1.28SECTION 886.1400
     886.1400 Maddox lens.
21:8.0.1.1.30.2.1.29SECTION 886.1405
     886.1405 Ophthalmic trial lens set.
21:8.0.1.1.30.2.1.30SECTION 886.1410
     886.1410 Ophthalmic trial lens clip.
21:8.0.1.1.30.2.1.31SECTION 886.1415
     886.1415 Ophthalmic trial lens frame.
21:8.0.1.1.30.2.1.32SECTION 886.1420
     886.1420 Ophthalmic lens gauge.
21:8.0.1.1.30.2.1.33SECTION 886.1425
     886.1425 Lens measuring instrument.
21:8.0.1.1.30.2.1.34SECTION 886.1430
     886.1430 Ophthalmic contact lens radius measuring device.
21:8.0.1.1.30.2.1.35SECTION 886.1435
     886.1435 Maxwell spot.
21:8.0.1.1.30.2.1.36SECTION 886.1450
     886.1450 Corneal radius measuring device.
21:8.0.1.1.30.2.1.37SECTION 886.1460
     886.1460 Stereopsis measuring instrument.
21:8.0.1.1.30.2.1.38SECTION 886.1500
     886.1500 Headband mirror.
21:8.0.1.1.30.2.1.39SECTION 886.1510
     886.1510 Eye movement monitor.
21:8.0.1.1.30.2.1.40SECTION 886.1570
     886.1570 Ophthalmoscope.
21:8.0.1.1.30.2.1.41SECTION 886.1605
     886.1605 Perimeter.
21:8.0.1.1.30.2.1.42SECTION 886.1630
     886.1630 AC-powered photostimulator.
21:8.0.1.1.30.2.1.43SECTION 886.1640
     886.1640 Ophthalmic preamplifier.
21:8.0.1.1.30.2.1.44SECTION 886.1650
     886.1650 Ophthalmic bar prism.
21:8.0.1.1.30.2.1.45SECTION 886.1655
     886.1655 Ophthalmic Fresnel prism.
21:8.0.1.1.30.2.1.46SECTION 886.1660
     886.1660 Gonioscopic prism.
21:8.0.1.1.30.2.1.47SECTION 886.1665
     886.1665 Ophthalmic rotary prism.
21:8.0.1.1.30.2.1.48SECTION 886.1670
     886.1670 Ophthalmic isotope uptake probe.
21:8.0.1.1.30.2.1.49SECTION 886.1680
     886.1680 Ophthalmic projector.
21:8.0.1.1.30.2.1.50SECTION 886.1690
     886.1690 Pupillograph.
21:8.0.1.1.30.2.1.51SECTION 886.1700
     886.1700 Pupillometer.
21:8.0.1.1.30.2.1.52SECTION 886.1750
     886.1750 Skiascopic rack.
21:8.0.1.1.30.2.1.53SECTION 886.1760
     886.1760 Ophthalmic refractometer.
21:8.0.1.1.30.2.1.54SECTION 886.1770
     886.1770 Manual refractor.
21:8.0.1.1.30.2.1.55SECTION 886.1780
     886.1780 Retinoscope.
21:8.0.1.1.30.2.1.56SECTION 886.1790
     886.1790 Nearpoint ruler.
21:8.0.1.1.30.2.1.57SECTION 886.1800
     886.1800 Schirmer strip.
21:8.0.1.1.30.2.1.58SECTION 886.1810
     886.1810 Tangent screen (campimeter).
21:8.0.1.1.30.2.1.59SECTION 886.1840
     886.1840 Simulatan (including crossed cylinder).
21:8.0.1.1.30.2.1.60SECTION 886.1850
     886.1850 AC-powered slitlamp biomicroscope.
21:8.0.1.1.30.2.1.61SECTION 886.1860
     886.1860 Ophthalmic instrument stand.
21:8.0.1.1.30.2.1.62SECTION 886.1870
     886.1870 Stereoscope.
21:8.0.1.1.30.2.1.63SECTION 886.1880
     886.1880 Fusion and stereoscopic target.
21:8.0.1.1.30.2.1.64SECTION 886.1905
     886.1905 Nystagmus tape.
21:8.0.1.1.30.2.1.65SECTION 886.1910
     886.1910 Spectacle dissociation test system.
21:8.0.1.1.30.2.1.66SECTION 886.1925
     886.1925 Diurnal pattern recorder system.
21:8.0.1.1.30.2.1.67SECTION 886.1930
     886.1930 Tonometer and accessories.
21:8.0.1.1.30.2.1.68SECTION 886.1940
     886.1940 Tonometer sterilizer.
21:8.0.1.1.30.2.1.69SECTION 886.1945
     886.1945 Transilluminator.
21:8.0.1.1.30.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.30.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.30.4.1.1SECTION 886.3100
     886.3100 Ophthalmic tantalum clip.
21:8.0.1.1.30.4.1.2SECTION 886.3130
     886.3130 Ophthalmic conformer.
21:8.0.1.1.30.4.1.3SECTION 886.3200
     886.3200 Artificial eye.
21:8.0.1.1.30.4.1.4SECTION 886.3300
     886.3300 Absorbable implant (scleral buckling method).
21:8.0.1.1.30.4.1.5SECTION 886.3320
     886.3320 Eye sphere implant.
21:8.0.1.1.30.4.1.6SECTION 886.3340
     886.3340 Extraocular orbital implant.
21:8.0.1.1.30.4.1.7SECTION 886.3400
     886.3400 Keratoprosthesis.
21:8.0.1.1.30.4.1.8SECTION 886.3600
     886.3600 Intraocular lens.
21:8.0.1.1.30.4.1.9SECTION 886.3800
     886.3800 Scleral shell.
21:8.0.1.1.30.4.1.10SECTION 886.3920
     886.3920 Aqueous shunt.
21:8.0.1.1.30.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.30.5.1.1SECTION 886.4070
     886.4070 Powered corneal burr.
21:8.0.1.1.30.5.1.2SECTION 886.4100
     886.4100 Radiofrequency electrosurgical cautery apparatus.
21:8.0.1.1.30.5.1.3SECTION 886.4115
     886.4115 Thermal cautery unit.
21:8.0.1.1.30.5.1.4SECTION 886.4150
     886.4150 Vitreous aspiration and cutting instrument.
21:8.0.1.1.30.5.1.5SECTION 886.4155
     886.4155 Scleral plug.
21:8.0.1.1.30.5.1.6SECTION 886.4170
     886.4170 Cryophthalmic unit.
21:8.0.1.1.30.5.1.7SECTION 886.4230
     886.4230 Ophthalmic knife test drum.
21:8.0.1.1.30.5.1.8SECTION 886.4250
     886.4250 Ophthalmic electrolysis unit.
21:8.0.1.1.30.5.1.9SECTION 886.4270
     886.4270 Intraocular gas.
21:8.0.1.1.30.5.1.10SECTION 886.4275
     886.4275 Intraocular fluid.
21:8.0.1.1.30.5.1.11SECTION 886.4280
     886.4280 Intraocular pressure measuring device.
21:8.0.1.1.30.5.1.12SECTION 886.4300
     886.4300 Intraocular lens guide.
21:8.0.1.1.30.5.1.13SECTION 886.4335
     886.4335 Operating headlamp.
21:8.0.1.1.30.5.1.14SECTION 886.4350
     886.4350 Manual ophthalmic surgical instrument.
21:8.0.1.1.30.5.1.15SECTION 886.4355
     886.4355 Corneal inlay inserter handle.
21:8.0.1.1.30.5.1.16SECTION 886.4360
     886.4360 Ocular surgery irrigation device.
21:8.0.1.1.30.5.1.17SECTION 886.4370
     886.4370 Keratome.
21:8.0.1.1.30.5.1.18SECTION 886.4390
     886.4390 Ophthalmic laser.
21:8.0.1.1.30.5.1.19SECTION 886.4392
     886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
21:8.0.1.1.30.5.1.20SECTION 886.4400
     886.4400 Electronic metal locator.
21:8.0.1.1.30.5.1.21SECTION 886.4440
     886.4440 AC-powered magnet.
21:8.0.1.1.30.5.1.22SECTION 886.4445
     886.4445 Permanent magnet.
21:8.0.1.1.30.5.1.23SECTION 886.4570
     886.4570 Ophthalmic surgical marker.
21:8.0.1.1.30.5.1.24SECTION 886.4610
     886.4610 Ocular pressure applicator.
21:8.0.1.1.30.5.1.25SECTION 886.4670
     886.4670 Phacofragmentation system.
21:8.0.1.1.30.5.1.26SECTION 886.4690
     886.4690 Ophthalmic photocoagulator.
21:8.0.1.1.30.5.1.27SECTION 886.4750
     886.4750 Ophthalmic eye shield.
21:8.0.1.1.30.5.1.28SECTION 886.4770
     886.4770 Ophthalmic operating spectacles (loupes).
21:8.0.1.1.30.5.1.29SECTION 886.4790
     886.4790 Ophthalmic sponge.
21:8.0.1.1.30.5.1.30SECTION 886.4855
     886.4855 Ophthalmic instrument table.
21:8.0.1.1.30.6SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.30.6.1.1SECTION 886.5100
     886.5100 Ophthalmic beta radiation source.
21:8.0.1.1.30.6.1.2SECTION 886.5120
     886.5120 Low-power binocular loupe.
21:8.0.1.1.30.6.1.3SECTION 886.5200
     886.5200 Eyelid thermal pulsation system.
21:8.0.1.1.30.6.1.4SECTION 886.5300
     886.5300 Tear electrostimulation device.
21:8.0.1.1.30.6.1.5SECTION 886.5310
     886.5310 Intranasal electrostimulation device for dry eye symptoms.
21:8.0.1.1.30.6.1.6SECTION 886.5420
     886.5420 Contact lens inserter/remover.
21:8.0.1.1.30.6.1.7SECTION 886.5540
     886.5540 Low-vision magnifier.
21:8.0.1.1.30.6.1.8SECTION 886.5600
     886.5600 Ptosis crutch.
21:8.0.1.1.30.6.1.9SECTION 886.5700
     886.5700 Eyelid weight.
21:8.0.1.1.30.6.1.10SECTION 886.5800
     886.5800 Ophthalmic bar reader.
21:8.0.1.1.30.6.1.11SECTION 886.5810
     886.5810 Ophthalmic prism reader.
21:8.0.1.1.30.6.1.12SECTION 886.5820
     886.5820 Closed-circuit television reading system.
21:8.0.1.1.30.6.1.13SECTION 886.5838
     886.5838 Nasolacrimal compression device.
21:8.0.1.1.30.6.1.14SECTION 886.5840
     886.5840 Magnifying spectacles.
21:8.0.1.1.30.6.1.15SECTION 886.5842
     886.5842 Spectacle frame.
21:8.0.1.1.30.6.1.16SECTION 886.5844
     886.5844 Prescription spectacle lens.
21:8.0.1.1.30.6.1.17SECTION 886.5850
     886.5850 Sunglasses (nonprescription).
21:8.0.1.1.30.6.1.18SECTION 886.5870
     886.5870 Low-vision telescope.
21:8.0.1.1.30.6.1.19SECTION 886.5900
     886.5900 Electronic vision aid.
21:8.0.1.1.30.6.1.20SECTION 886.5905
     886.5905 Oral electronic vision aid.
21:8.0.1.1.30.6.1.21SECTION 886.5910
     886.5910 Image intensification vision aid.
21:8.0.1.1.30.6.1.22SECTION 886.5915
     886.5915 Optical vision aid.
21:8.0.1.1.30.6.1.23SECTION 886.5916
     886.5916 Rigid gas permeable contact lens.
21:8.0.1.1.30.6.1.24SECTION 886.5918
     886.5918 Rigid gas permeable contact lens care products.
21:8.0.1.1.30.6.1.25SECTION 886.5925
     886.5925 Soft (hydrophilic) contact lens.
21:8.0.1.1.30.6.1.26SECTION 886.5928
     886.5928 Soft (hydrophilic) contact lens care products.
21:8.0.1.1.30.6.1.27SECTION 886.5933
     886.5933 [Reserved]
21:8.0.1.1.31PART 888
PART 888 - ORTHOPEDIC DEVICES
21:8.0.1.1.31.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.31.1.1.1SECTION 888.1
     888.1 Scope.
21:8.0.1.1.31.1.1.2SECTION 888.3
     888.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.31.1.1.3SECTION 888.5
     888.5 Resurfacing technique.
21:8.0.1.1.31.1.1.4SECTION 888.6
     888.6 Degree of constraint.
21:8.0.1.1.31.1.1.5SECTION 888.9
     888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.31.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.31.2.1.1SECTION 888.1100
     888.1100 Arthroscope.
21:8.0.1.1.31.2.1.2SECTION 888.1240
     888.1240 AC-powered dynamometer.
21:8.0.1.1.31.2.1.3SECTION 888.1250
     888.1250 Nonpowered dynamometer.
21:8.0.1.1.31.2.1.4SECTION 888.1500
     888.1500 Goniometer.
21:8.0.1.1.31.2.1.5SECTION 888.1520
     888.1520 Nonpowered goniometer.
21:8.0.1.1.31.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.31.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.31.4.1.1SECTION 888.3000
     888.3000 Bone cap.
21:8.0.1.1.31.4.1.2SECTION 888.3010
     888.3010 Bone fixation cerclage.
21:8.0.1.1.31.4.1.3SECTION 888.3015
     888.3015 Bone heterograft.
21:8.0.1.1.31.4.1.4SECTION 888.3020
     888.3020 Intramedullary fixation rod.
21:8.0.1.1.31.4.1.5SECTION 888.3023
     888.3023 In vivo cured intramedullary fixation rod.
21:8.0.1.1.31.4.1.6SECTION 888.3025
     888.3025 Passive tendon prosthesis.
21:8.0.1.1.31.4.1.7SECTION 888.3027
     888.3027 Polymethylmethacrylate (PMMA) bone cement.
21:8.0.1.1.31.4.1.8SECTION 888.3030
     888.3030 Single/multiple component metallic bone fixation appliances and accessories.
21:8.0.1.1.31.4.1.9SECTION 888.3040
     888.3040 Smooth or threaded metallic bone fixation fastener.
21:8.0.1.1.31.4.1.10SECTION 888.3045
     888.3045 Resorbable calcium salt bone void filler device.
21:8.0.1.1.31.4.1.11SECTION 888.3050
     888.3050 Spinal interlaminal fixation orthosis.
21:8.0.1.1.31.4.1.12SECTION 888.3060
     888.3060 Spinal intervertebral body fixation orthosis.
21:8.0.1.1.31.4.1.13SECTION 888.3070
     888.3070 Thoracolumbosacral pedicle screw system.
21:8.0.1.1.31.4.1.14SECTION 888.3075
     888.3075 Posterior cervical screw system.
21:8.0.1.1.31.4.1.15SECTION 888.3080
     888.3080 Intervertebral body fusion device.
21:8.0.1.1.31.4.1.16SECTION 888.3100
     888.3100 Ankle joint metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.17SECTION 888.3110
     888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.18SECTION 888.3120
     888.3120 Ankle joint metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.19SECTION 888.3150
     888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.20SECTION 888.3160
     888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.21SECTION 888.3170
     888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
21:8.0.1.1.31.4.1.22SECTION 888.3180
     888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.23SECTION 888.3200
     888.3200 Finger joint metal/metal constrained uncemented prosthesis.
21:8.0.1.1.31.4.1.24SECTION 888.3210
     888.3210 Finger joint metal/metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.25SECTION 888.3220
     888.3220 Finger joint metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.26SECTION 888.3230
     888.3230 Finger joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.27SECTION 888.3300
     888.3300 Hip joint metal constrained cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.28SECTION 888.3310
     888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.29SECTION 888.3320
     888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
21:8.0.1.1.31.4.1.30SECTION 888.3330
     888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
21:8.0.1.1.31.4.1.31SECTION 888.3340
     888.3340 Hip joint metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.32SECTION 888.3350
     888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.33SECTION 888.3353
     888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
21:8.0.1.1.31.4.1.34SECTION 888.3358
     888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.35SECTION 888.3360
     888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.36SECTION 888.3370
     888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis.
21:8.0.1.1.31.4.1.37SECTION 888.3380
     888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
21:8.0.1.1.31.4.1.38SECTION 888.3390
     888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.39SECTION 888.3400
     888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
21:8.0.1.1.31.4.1.40SECTION 888.3410
     888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
21:8.0.1.1.31.4.1.41SECTION 888.3480
     888.3480 Knee joint femorotibial metallic constrained cemented prosthesis.
21:8.0.1.1.31.4.1.42SECTION 888.3490
     888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.43SECTION 888.3500
     888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.44SECTION 888.3510
     888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.45SECTION 888.3520
     888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.46SECTION 888.3530
     888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.47SECTION 888.3535
     888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.48SECTION 888.3540
     888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.49SECTION 888.3550
     888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.50SECTION 888.3560
     888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.51SECTION 888.3565
     888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.52SECTION 888.3570
     888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.53SECTION 888.3580
     888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
21:8.0.1.1.31.4.1.54SECTION 888.3590
     888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
21:8.0.1.1.31.4.1.55SECTION 888.3640
     888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.56SECTION 888.3650
     888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.57SECTION 888.3660
     888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.58SECTION 888.3670
     888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.59SECTION 888.3680
     888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
21:8.0.1.1.31.4.1.60SECTION 888.3690
     888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.61SECTION 888.3720
     888.3720 Toe joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.62SECTION 888.3730
     888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
21:8.0.1.1.31.4.1.63SECTION 888.3750
     888.3750 Wrist joint carpal lunate polymer prosthesis.
21:8.0.1.1.31.4.1.64SECTION 888.3760
     888.3760 Wrist joint carpal scaphoid polymer prosthesis.
21:8.0.1.1.31.4.1.65SECTION 888.3770
     888.3770 Wrist joint carpal trapezium polymer prosthesis.
21:8.0.1.1.31.4.1.66SECTION 888.3780
     888.3780 Wrist joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.67SECTION 888.3790
     888.3790 Wrist joint metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.68SECTION 888.3800
     888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.69SECTION 888.3810
     888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
21:8.0.1.1.31.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.31.5.1.1SECTION 888.4150
     888.4150 Calipers for clinical use.
21:8.0.1.1.31.5.1.2SECTION 888.4200
     888.4200 Cement dispenser.
21:8.0.1.1.31.5.1.3SECTION 888.4210
     888.4210 Cement mixer for clinical use.
21:8.0.1.1.31.5.1.4SECTION 888.4220
     888.4220 Cement monomer vapor evacuator.
21:8.0.1.1.31.5.1.5SECTION 888.4230
     888.4230 Cement ventilation tube.
21:8.0.1.1.31.5.1.6SECTION 888.4300
     888.4300 Depth gauge for clinical use.
21:8.0.1.1.31.5.1.7SECTION 888.4505
     888.4505 Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.
21:8.0.1.1.31.5.1.8SECTION 888.4540
     888.4540 Orthopedic manual surgical instrument.
21:8.0.1.1.31.5.1.9SECTION 888.4580
     888.4580 Sonic surgical instrument and accessories/attachments.
21:8.0.1.1.31.5.1.10SECTION 888.4600
     888.4600 Protractor for clinical use.
21:8.0.1.1.31.5.1.11SECTION 888.4800
     888.4800 Template for clinical use.
21:8.0.1.1.31.5.1.12SECTION 888.5850
     888.5850 Nonpowered orthopedic traction apparatus and accessories.
21:8.0.1.1.31.5.1.13SECTION 888.5890
     888.5890 Noninvasive traction component.
21:8.0.1.1.31.5.1.14SECTION 888.5940
     888.5940 Cast component.
21:8.0.1.1.31.5.1.15SECTION 888.5960
     888.5960 Cast removal instrument.
21:8.0.1.1.31.5.1.16SECTION 888.5980
     888.5980 Manual cast application and removal instrument.
21:8.0.1.1.32PART 890
PART 890 - PHYSICAL MEDICINE DEVICES
21:8.0.1.1.32.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.32.1.1.1SECTION 890.1
     890.1 Scope.
21:8.0.1.1.32.1.1.2SECTION 890.3
     890.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.32.1.1.3SECTION 890.9
     890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.32.2SUBPART B
Subpart B - Physical Medicine Diagnostic Devices
21:8.0.1.1.32.2.1.1SECTION 890.1175
     890.1175 Electrode cable.
21:8.0.1.1.32.2.1.2SECTION 890.1225
     890.1225 Chronaximeter.
21:8.0.1.1.32.2.1.3SECTION 890.1375
     890.1375 Diagnostic electromyograph.
21:8.0.1.1.32.2.1.4SECTION 890.1385
     890.1385 Diagnostic electromyograph needle electrode.
21:8.0.1.1.32.2.1.5SECTION 890.1450
     890.1450 Powered reflex hammer.
21:8.0.1.1.32.2.1.6SECTION 890.1575
     890.1575 Force-measuring platform.
21:8.0.1.1.32.2.1.7SECTION 890.1600
     890.1600 Intermittent pressure measurement system.
21:8.0.1.1.32.2.1.8SECTION 890.1615
     890.1615 Miniature pressure transducer.
21:8.0.1.1.32.2.1.9SECTION 890.1850
     890.1850 Diagnostic muscle stimulator.
21:8.0.1.1.32.2.1.10SECTION 890.1925
     890.1925 Isokinetic testing and evaluation system.
21:8.0.1.1.32.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.32.4SUBPART D
Subpart D - Physical Medicine Prosthetic Devices
21:8.0.1.1.32.4.1.1SECTION 890.3025
     890.3025 Prosthetic and orthotic accessory.
21:8.0.1.1.32.4.1.2SECTION 890.3075
     890.3075 Cane.
21:8.0.1.1.32.4.1.3SECTION 890.3100
     890.3100 Mechanical chair.
21:8.0.1.1.32.4.1.4SECTION 890.3110
     890.3110 Electric positioning chair.
21:8.0.1.1.32.4.1.5SECTION 890.3150
     890.3150 Crutch.
21:8.0.1.1.32.4.1.6SECTION 890.3175
     890.3175 Flotation cushion.
21:8.0.1.1.32.4.1.7SECTION 890.3410
     890.3410 External limb orthotic component.
21:8.0.1.1.32.4.1.8SECTION 890.3420
     890.3420 External limb prosthetic component.
21:8.0.1.1.32.4.1.9SECTION 890.3450
     890.3450 Upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components.
21:8.0.1.1.32.4.1.10SECTION 890.3475
     890.3475 Limb orthosis.
21:8.0.1.1.32.4.1.11SECTION 890.3480
     890.3480 Powered lower extremity exoskeleton.
21:8.0.1.1.32.4.1.12SECTION 890.3490
     890.3490 Truncal orthosis.
21:8.0.1.1.32.4.1.13SECTION 890.3500
     890.3500 External assembled lower limb prosthesis.
21:8.0.1.1.32.4.1.14SECTION 890.3520
     890.3520 Plinth.
21:8.0.1.1.32.4.1.15SECTION 890.3610
     890.3610 Rigid pneumatic structure orthosis.
21:8.0.1.1.32.4.1.16SECTION 890.3640
     890.3640 Arm sling.
21:8.0.1.1.32.4.1.17SECTION 890.3665
     890.3665 Congenital hip dislocation abduction splint.
21:8.0.1.1.32.4.1.18SECTION 890.3675
     890.3675 Denis Brown splint.
21:8.0.1.1.32.4.1.19SECTION 890.3690
     890.3690 Powered wheeled stretcher.
21:8.0.1.1.32.4.1.20SECTION 890.3700
     890.3700 Nonpowered communication system.
21:8.0.1.1.32.4.1.21SECTION 890.3710
     890.3710 Powered communication system.
21:8.0.1.1.32.4.1.22SECTION 890.3725
     890.3725 Powered environmental control system.
21:8.0.1.1.32.4.1.23SECTION 890.3750
     890.3750 Mechanical table.
21:8.0.1.1.32.4.1.24SECTION 890.3760
     890.3760 Powered table.
21:8.0.1.1.32.4.1.25SECTION 890.3790
     890.3790 Cane, crutch, and walker tips and pads.
21:8.0.1.1.32.4.1.26SECTION 890.3800
     890.3800 Motorized three-wheeled vehicle.
21:8.0.1.1.32.4.1.27SECTION 890.3825
     890.3825 Mechanical walker.
21:8.0.1.1.32.4.1.28SECTION 890.3850
     890.3850 Mechanical wheelchair.
21:8.0.1.1.32.4.1.29SECTION 890.3860
     890.3860 Powered wheelchair.
21:8.0.1.1.32.4.1.30SECTION 890.3880
     890.3880 Special grade wheelchair.
21:8.0.1.1.32.4.1.31SECTION 890.3890
     890.3890 Stair-climbing wheelchair.
21:8.0.1.1.32.4.1.32SECTION 890.3900
     890.3900 Standup wheelchair.
21:8.0.1.1.32.4.1.33SECTION 890.3910
     890.3910 Wheelchair accessory.
21:8.0.1.1.32.4.1.34SECTION 890.3920
     890.3920 Wheelchair component.
21:8.0.1.1.32.4.1.35SECTION 890.3930
     890.3930 Wheelchair elevator.
21:8.0.1.1.32.4.1.36SECTION 890.3940
     890.3940 Wheelchair platform scale.
21:8.0.1.1.32.5SUBPART E
Subpart E [Reserved]
21:8.0.1.1.32.6SUBPART F
Subpart F - Physical Medicine Therapeutic Devices
21:8.0.1.1.32.6.1.1SECTION 890.5050
     890.5050 Daily activity assist device.
21:8.0.1.1.32.6.1.2SECTION 890.5100
     890.5100 Immersion hydrobath.
21:8.0.1.1.32.6.1.3SECTION 890.5110
     890.5110 Paraffin bath.
21:8.0.1.1.32.6.1.4SECTION 890.5125
     890.5125 Nonpowered sitz bath.
21:8.0.1.1.32.6.1.5SECTION 890.5150
     890.5150 Powered patient transport.
21:8.0.1.1.32.6.1.6SECTION 890.5160
     890.5160 Air-fluidized bed.
21:8.0.1.1.32.6.1.7SECTION 890.5170
     890.5170 Powered flotation therapy bed.
21:8.0.1.1.32.6.1.8SECTION 890.5180
     890.5180 Manual patient rotation bed.
21:8.0.1.1.32.6.1.9SECTION 890.5225
     890.5225 Powered patient rotation bed.
21:8.0.1.1.32.6.1.10SECTION 890.5250
     890.5250 Moist steam cabinet.
21:8.0.1.1.32.6.1.11SECTION 890.5275
     890.5275 Microwave diathermy.
21:8.0.1.1.32.6.1.12SECTION 890.5290
     890.5290 Shortwave diathermy.
21:8.0.1.1.32.6.1.13SECTION 890.5300
     890.5300 Ultrasonic diathermy.
21:8.0.1.1.32.6.1.14SECTION 890.5350
     890.5350 Exercise component.
21:8.0.1.1.32.6.1.15SECTION 890.5360
     890.5360 Measuring exercise equipment.
21:8.0.1.1.32.6.1.16SECTION 890.5370
     890.5370 Nonmeasuring exercise equipment.
21:8.0.1.1.32.6.1.17SECTION 890.5380
     890.5380 Powered exercise equipment.
21:8.0.1.1.32.6.1.18SECTION 890.5410
     890.5410 Powered finger exerciser.
21:8.0.1.1.32.6.1.19SECTION 890.5500
     890.5500 Infrared lamp.
21:8.0.1.1.32.6.1.20SECTION 890.5525
     890.5525 Iontophoresis device.
21:8.0.1.1.32.6.1.21SECTION 890.5575
     890.5575 Powered external limb overload warning device.
21:8.0.1.1.32.6.1.22SECTION 890.5650
     890.5650 Powered inflatable tube massager.
21:8.0.1.1.32.6.1.23SECTION 890.5660
     890.5660 Therapeutic massager.
21:8.0.1.1.32.6.1.24SECTION 890.5670
     890.5670 Internal therapeutic massager.
21:8.0.1.1.32.6.1.25SECTION 890.5700
     890.5700 Cold pack.
21:8.0.1.1.32.6.1.26SECTION 890.5710
     890.5710 Hot or cold disposable pack.
21:8.0.1.1.32.6.1.27SECTION 890.5720
     890.5720 Water circulating hot or cold pack.
21:8.0.1.1.32.6.1.28SECTION 890.5730
     890.5730 Moist heat pack.
21:8.0.1.1.32.6.1.29SECTION 890.5740
     890.5740 Powered heating pad.
21:8.0.1.1.32.6.1.30SECTION 890.5760
     890.5760 Nonpowered lower extremity pressure wrap.
21:8.0.1.1.32.6.1.31SECTION 890.5765
     890.5765 Pressure-applying device.
21:8.0.1.1.32.6.1.32SECTION 890.5850
     890.5850 Powered muscle stimulator.
21:8.0.1.1.32.6.1.33SECTION 890.5860
     890.5860 Ultrasound and muscle stimulator.
21:8.0.1.1.32.6.1.34SECTION 890.5880
     890.5880 Multi-function physical therapy table.
21:8.0.1.1.32.6.1.35SECTION 890.5900
     890.5900 Power traction equipment.
21:8.0.1.1.32.6.1.36SECTION 890.5925
     890.5925 Traction accessory.
21:8.0.1.1.32.6.1.37SECTION 890.5940
     890.5940 Chilling unit.
21:8.0.1.1.32.6.1.38SECTION 890.5950
     890.5950 Powered heating unit.
21:8.0.1.1.32.6.1.39SECTION 890.5975
     890.5975 Therapeutic vibrator.
21:8.0.1.1.33PART 892
PART 892 - RADIOLOGY DEVICES
21:8.0.1.1.33.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.33.1.1.1SECTION 892.1
     892.1 Scope.
21:8.0.1.1.33.1.1.2SECTION 892.3
     892.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.33.1.1.3SECTION 892.9
     892.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.33.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.33.2.1.1SECTION 892.1000
     892.1000 Magnetic resonance diagnostic device.
21:8.0.1.1.33.2.1.2SECTION 892.1100
     892.1100 Scintillation (gamma) camera.
21:8.0.1.1.33.2.1.3SECTION 892.1110
     892.1110 Positron camera.
21:8.0.1.1.33.2.1.4SECTION 892.1130
     892.1130 Nuclear whole body counter.
21:8.0.1.1.33.2.1.5SECTION 892.1170
     892.1170 Bone densitometer.
21:8.0.1.1.33.2.1.6SECTION 892.1180
     892.1180 Bone sonometer.
21:8.0.1.1.33.2.1.7SECTION 892.1200
     892.1200 Emission computed tomography system.
21:8.0.1.1.33.2.1.8SECTION 892.1220
     892.1220 Fluorescent scanner.
21:8.0.1.1.33.2.1.9SECTION 892.1300
     892.1300 Nuclear rectilinear scanner.
21:8.0.1.1.33.2.1.10SECTION 892.1310
     892.1310 Nuclear tomography system.
21:8.0.1.1.33.2.1.11SECTION 892.1320
     892.1320 Nuclear uptake probe.
21:8.0.1.1.33.2.1.12SECTION 892.1330
     892.1330 Nuclear whole body scanner.
21:8.0.1.1.33.2.1.13SECTION 892.1350
     892.1350 Nuclear scanning bed.
21:8.0.1.1.33.2.1.14SECTION 892.1360
     892.1360 Radionuclide dose calibrator.
21:8.0.1.1.33.2.1.15SECTION 892.1370
     892.1370 Nuclear anthropomorphic phantom.
21:8.0.1.1.33.2.1.16SECTION 892.1380
     892.1380 Nuclear flood source phantom.
21:8.0.1.1.33.2.1.17SECTION 892.1390
     892.1390 Radionuclide rebreathing system.
21:8.0.1.1.33.2.1.18SECTION 892.1400
     892.1400 Nuclear sealed calibration source.
21:8.0.1.1.33.2.1.19SECTION 892.1410
     892.1410 Nuclear electrocardiograph synchronizer.
21:8.0.1.1.33.2.1.20SECTION 892.1420
     892.1420 Radionuclide test pattern phantom.
21:8.0.1.1.33.2.1.21SECTION 892.1540
     892.1540 Nonfetal ultrasonic monitor.
21:8.0.1.1.33.2.1.22SECTION 892.1550
     892.1550 Ultrasonic pulsed doppler imaging system.
21:8.0.1.1.33.2.1.23SECTION 892.1560
     892.1560 Ultrasonic pulsed echo imaging system.
21:8.0.1.1.33.2.1.24SECTION 892.1570
     892.1570 Diagnostic ultrasonic transducer.
21:8.0.1.1.33.2.1.25SECTION 892.1600
     892.1600 Angiographic x-ray system.
21:8.0.1.1.33.2.1.26SECTION 892.1610
     892.1610 Diagnostic x-ray beam-limiting device.
21:8.0.1.1.33.2.1.27SECTION 892.1620
     892.1620 Cine or spot fluorographic x-ray camera.
21:8.0.1.1.33.2.1.28SECTION 892.1630
     892.1630 Electrostatic x-ray imaging system.
21:8.0.1.1.33.2.1.29SECTION 892.1640
     892.1640 Radiographic film marking system.
21:8.0.1.1.33.2.1.30SECTION 892.1650
     892.1650 Image-intensified fluoroscopic x-ray system.
21:8.0.1.1.33.2.1.31SECTION 892.1660
     892.1660 Non-image-intensified fluoroscopic x-ray system.
21:8.0.1.1.33.2.1.32SECTION 892.1670
     892.1670 Spot-film device.
21:8.0.1.1.33.2.1.33SECTION 892.1680
     892.1680 Stationary x-ray system.
21:8.0.1.1.33.2.1.34SECTION 892.1700
     892.1700 Diagnostic x-ray high voltage generator.
21:8.0.1.1.33.2.1.35SECTION 892.1710
     892.1710 Mammographic x-ray system.
21:8.0.1.1.33.2.1.36SECTION 892.1715
     892.1715 Full-field digital mammography system.
21:8.0.1.1.33.2.1.37SECTION 892.1720
     892.1720 Mobile x-ray system.
21:8.0.1.1.33.2.1.38SECTION 892.1730
     892.1730 Photofluorographic x-ray system.
21:8.0.1.1.33.2.1.39SECTION 892.1740
     892.1740 Tomographic x-ray system.
21:8.0.1.1.33.2.1.40SECTION 892.1750
     892.1750 Computed tomography x-ray system.
21:8.0.1.1.33.2.1.41SECTION 892.1760
     892.1760 Diagnostic x-ray tube housing assembly.
21:8.0.1.1.33.2.1.42SECTION 892.1770
     892.1770 Diagnostic x-ray tube mount.
21:8.0.1.1.33.2.1.43SECTION 892.1820
     892.1820 Pneumoencephalographic chair.
21:8.0.1.1.33.2.1.44SECTION 892.1830
     892.1830 Radiologic patient cradle.
21:8.0.1.1.33.2.1.45SECTION 892.1840
     892.1840 Radiographic film.
21:8.0.1.1.33.2.1.46SECTION 892.1850
     892.1850 Radiographic film cassette.
21:8.0.1.1.33.2.1.47SECTION 892.1860
     892.1860 Radiographic film/cassette changer.
21:8.0.1.1.33.2.1.48SECTION 892.1870
     892.1870 Radiographic film/cassette changer programmer.
21:8.0.1.1.33.2.1.49SECTION 892.1880
     892.1880 Wall-mounted radiographic cassette holder.
21:8.0.1.1.33.2.1.50SECTION 892.1890
     892.1890 Radiographic film illuminator.
21:8.0.1.1.33.2.1.51SECTION 892.1900
     892.1900 Automatic radiographic film processor.
21:8.0.1.1.33.2.1.52SECTION 892.1910
     892.1910 Radiographic grid.
21:8.0.1.1.33.2.1.53SECTION 892.1920
     892.1920 Radiographic head holder.
21:8.0.1.1.33.2.1.54SECTION 892.1940
     892.1940 Radiologic quality assurance instrument.
21:8.0.1.1.33.2.1.55SECTION 892.1950
     892.1950 Radiographic anthropomorphic phantom.
21:8.0.1.1.33.2.1.56SECTION 892.1960
     892.1960 Radiographic intensifying screen.
21:8.0.1.1.33.2.1.57SECTION 892.1970
     892.1970 Radiographic ECG/respirator synchronizer.
21:8.0.1.1.33.2.1.58SECTION 892.1980
     892.1980 Radiologic table.
21:8.0.1.1.33.2.1.59SECTION 892.1990
     892.1990 Transilluminator for breast evaluation.
21:8.0.1.1.33.2.1.60SECTION 892.2010
     892.2010 Medical image storage device.
21:8.0.1.1.33.2.1.61SECTION 892.2020
     892.2020 Medical image communications device.
21:8.0.1.1.33.2.1.62SECTION 892.2030
     892.2030 Medical image digitizer.
21:8.0.1.1.33.2.1.63SECTION 892.2040
     892.2040 Medical image hardcopy device.
21:8.0.1.1.33.2.1.64SECTION 892.2050
     892.2050 Picture archiving and communications system.
21:8.0.1.1.33.2.1.65SECTION 892.2060
     892.2060 Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
21:8.0.1.1.33.2.1.66SECTION 892.2070
     892.2070 Medical image analyzer.
21:8.0.1.1.33.2.1.67SECTION 892.2080
     892.2080 Radiological computer aided triage and notification software.
21:8.0.1.1.33.3SUBPART C
Subparts C-E [Reserved]
21:8.0.1.1.33.4SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.33.4.1.1SECTION 892.5050
     892.5050 Medical charged-particle radiation therapy system.
21:8.0.1.1.33.4.1.2SECTION 892.5300
     892.5300 Medical neutron radiation therapy system.
21:8.0.1.1.33.4.1.3SECTION 892.5650
     892.5650 Manual radionuclide applicator system.
21:8.0.1.1.33.4.1.4SECTION 892.5700
     892.5700 Remote controlled radionuclide applicator system.
21:8.0.1.1.33.4.1.5SECTION 892.5710
     892.5710 Radiation therapy beam-shaping block.
21:8.0.1.1.33.4.1.6SECTION 892.5720
     892.5720 Rectal balloon for prostate immobilization.
21:8.0.1.1.33.4.1.7SECTION 892.5725
     892.5725 Absorbable perirectal spacer.
21:8.0.1.1.33.4.1.8SECTION 892.5730
     892.5730 Radionuclide brachytherapy source.
21:8.0.1.1.33.4.1.9SECTION 892.5740
     892.5740 Radionuclide teletherapy source.
21:8.0.1.1.33.4.1.10SECTION 892.5750
     892.5750 Radionuclide radiation therapy system.
21:8.0.1.1.33.4.1.11SECTION 892.5770
     892.5770 Powered radiation therapy patient support assembly.
21:8.0.1.1.33.4.1.12SECTION 892.5780
     892.5780 Light beam patient position indicator.
21:8.0.1.1.33.4.1.13SECTION 892.5840
     892.5840 Radiation therapy simulation system.
21:8.0.1.1.33.4.1.14SECTION 892.5900
     892.5900 X-ray radiation therapy system.
21:8.0.1.1.33.4.1.15SECTION 892.5930
     892.5930 Therapeutic x-ray tube housing assembly.
21:8.0.1.1.33.5SUBPART G
Subpart G - Miscellaneous Devices
21:8.0.1.1.33.5.1.1SECTION 892.6500
     892.6500 Personnel protective shield.
21:8.0.1.1.34PART 895
PART 895 - BANNED DEVICES
21:8.0.1.1.34.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.34.1.1.1SECTION 895.1
     895.1 Scope.
21:8.0.1.1.34.1.1.2SECTION 895.20
     895.20 General.
21:8.0.1.1.34.1.1.3SECTION 895.21
     895.21 Procedures for banning a device.
21:8.0.1.1.34.1.1.4SECTION 895.22
     895.22 Submission of data and information by the manufacturer, distributor, or importer.
21:8.0.1.1.34.1.1.5SECTION 895.25
     895.25 Labeling.
21:8.0.1.1.34.1.1.6SECTION 895.30
     895.30 Special effective date.
21:8.0.1.1.34.2SUBPART B
Subpart B - Listing of Banned Devices
21:8.0.1.1.34.2.1.1SECTION 895.101
     895.101 Prosthetic hair fibers.
21:8.0.1.1.34.2.1.2SECTION 895.102
     895.102 Powdered surgeon's glove.
21:8.0.1.1.34.2.1.3SECTION 895.103
     895.103 Powdered patient examination glove.
21:8.0.1.1.34.2.1.4SECTION 895.104
     895.104 Absorbable powder for lubricating a surgeon's glove.
21:8.0.1.1.34.2.1.5SECTION 895.105
     895.105 Electrical stimulation devices for self-injurious or aggressive behavior.
21:8.0.1.1.35PART 898
PART 898 - PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
21:8.0.1.1.35.0.1.1SECTION 898.11
     898.11 Applicability.
21:8.0.1.1.35.0.1.2SECTION 898.12
     898.12 Performance standard.
21:8.0.1.1.35.0.1.3SECTION 898.13
     898.13 Compliance dates.
21:8.0.1.1.35.0.1.4SECTION 898.14
     898.14 Exemptions and variances.