Title 21

Volume 8 CHAPTER I SUBCHAP H

Subchapter H - Medical Devices

21:8.0.1.1.1	PART 800	PART 800 - GENERAL
21:8.0.1.1.1.1	SUBPART A	Subpart A [Reserved]
21:8.0.1.1.1.2	SUBPART B	Subpart B - Requirements for Specific Medical Devices
21:8.0.1.1.1.2.1.1	SECTION 800.10	800.10 Contact lens solutions; sterility.
21:8.0.1.1.1.2.1.2	SECTION 800.12	800.12 Contact lens solutions and tablets; tamper-resistant packaging.
21:8.0.1.1.1.2.1.3	SECTION 800.20	800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration.
21:8.0.1.1.1.3	SUBPART C	Subpart C - Administrative Practices and Procedures
21:8.0.1.1.1.3.1.1	SECTION 800.55	800.55 Administrative detention.
21:8.0.1.1.1.3.1.2	SECTION 800.75	800.75 Requests for supervisory review of certain decisions made by the Center for Devices and Radiological Health.
21:8.0.1.1.2	PART 801	PART 801 - LABELING
21:8.0.1.1.2.1	SUBPART A	Subpart A - General Labeling Provisions
21:8.0.1.1.2.1.1.1	SECTION 801.1	801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
21:8.0.1.1.2.1.1.2	SECTION 801.3	801.3 Definitions.
21:8.0.1.1.2.1.1.3	SECTION 801.4	801.4 Meaning of intended uses.
21:8.0.1.1.2.1.1.5	SECTION 801.5	801.5 Medical devices; adequate directions for use.
21:8.0.1.1.2.1.1.6	SECTION 801.6	801.6 Medical devices; misleading statements.
21:8.0.1.1.2.1.1.7	SECTION 801.15	801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
21:8.0.1.1.2.1.1.8	SECTION 801.16	801.16 Medical devices; Spanish-language version of certain required statements.
21:8.0.1.1.2.1.1.9	SECTION 801.18	801.18 Format of dates provided on a medical device label.
21:8.0.1.1.2.2	SUBPART B	Subpart B - Labeling Requirements for Unique Device Identification
21:8.0.1.1.2.2.1.1	SECTION 801.20	801.20 Label to bear a unique device identifier.
21:8.0.1.1.2.2.1.2	SECTION 801.30	801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
21:8.0.1.1.2.2.1.3	SECTION 801.35	801.35 Voluntary labeling of a device with a unique device identifier.
21:8.0.1.1.2.2.1.4	SECTION 801.40	801.40 Form of a unique device identifier.
21:8.0.1.1.2.2.1.5	SECTION 801.45	801.45 Devices that must be directly marked with a unique device identifier.
21:8.0.1.1.2.2.1.6	SECTION 801.50	801.50 Labeling requirements for stand-alone software.
21:8.0.1.1.2.2.1.7	SECTION 801.55	801.55 Request for an exception from or alternative to a unique device identifier requirement.
21:8.0.1.1.2.2.1.8	SECTION 801.57	801.57 Discontinuation of legacy FDA identification numbers assigned to devices.
21:8.0.1.1.2.3	SUBPART C	Subpart C - Labeling Requirements for Over-the-Counter Devices
21:8.0.1.1.2.3.1.1	SECTION 801.60	801.60 Principal display panel.
21:8.0.1.1.2.3.1.2	SECTION 801.61	801.61 Statement of identity.
21:8.0.1.1.2.3.1.3	SECTION 801.62	801.62 Declaration of net quantity of contents.
21:8.0.1.1.2.3.1.4	SECTION 801.63	801.63 Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.
21:8.0.1.1.2.4	SUBPART D	Subpart D - Exemptions From Adequate Directions for Use
21:8.0.1.1.2.4.1.1	SECTION 801.109	801.109 Prescription devices.
21:8.0.1.1.2.4.1.2	SECTION 801.110	801.110 Retail exemption for prescription devices.
21:8.0.1.1.2.4.1.3	SECTION 801.116	801.116 Medical devices having commonly known directions.
21:8.0.1.1.2.4.1.4	SECTION 801.119	801.119 In vitro diagnostic products.
21:8.0.1.1.2.4.1.5	SECTION 801.122	801.122 Medical devices for processing, repacking, or manufacturing.
21:8.0.1.1.2.4.1.6	SECTION 801.125	801.125 Medical devices for use in teaching, law enforcement, research, and analysis.
21:8.0.1.1.2.4.1.7	SECTION 801.127	801.127 Medical devices; expiration of exemptions.
21:8.0.1.1.2.4.1.8	SECTION 801.128	801.128 Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
21:8.0.1.1.2.5	SUBPART E	Subpart E - Other Exemptions
21:8.0.1.1.2.5.1.1	SECTION 801.150	801.150 Medical devices; processing, labeling, or repacking.
21:8.0.1.1.2.6	SUBPART F	Subparts F-G [Reserved]
21:8.0.1.1.2.7	SUBPART H	Subpart H - Special Requirements for Specific Devices
21:8.0.1.1.2.7.1.1	SECTION 801.405	801.405 Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
21:8.0.1.1.2.7.1.2	SECTION 801.410	801.410 Use of impact-resistant lenses in eyeglasses and sunglasses.
21:8.0.1.1.2.7.1.3	SECTION 801.415	801.415 Maximum acceptable level of ozone.
21:8.0.1.1.2.7.1.4	SECTION 801.417	801.417 Chlorofluorocarbon propellants.
21:8.0.1.1.2.7.1.5	SECTION 801.420	801.420 Hearing aid devices; professional and patient labeling.
21:8.0.1.1.2.7.1.6	SECTION 801.421	801.421 Hearing aid devices; conditions for sale.
21:8.0.1.1.2.7.1.7	SECTION 801.430	801.430 User labeling for menstrual tampons.
21:8.0.1.1.2.7.1.8	SECTION 801.433	801.433 Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
21:8.0.1.1.2.7.1.9	SECTION 801.435	801.435 User labeling for latex condoms.
21:8.0.1.1.2.7.1.10	SECTION 801.437	801.437 User labeling for devices that contain natural rubber.
21:8.0.1.1.3	PART 803	PART 803 - MEDICAL DEVICE REPORTING
21:8.0.1.1.3.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.3.1.1.1	SECTION 803.1	803.1 What does this part cover
21:8.0.1.1.3.1.1.2	SECTION 803.3	803.3 How does FDA define the terms used in this part
21:8.0.1.1.3.1.1.3	SECTION 803.9	803.9 What information from the reports do we disclose to the public
21:8.0.1.1.3.1.1.4	SECTION 803.10	803.10 Generally, what are the reporting requirements that apply to me
21:8.0.1.1.3.1.1.5	SECTION 803.11	803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms
21:8.0.1.1.3.1.1.6	SECTION 803.12	803.12 How do I submit initial and supplemental or followup reports
21:8.0.1.1.3.1.1.7	SECTION 803.13	803.13 Do I need to submit reports in English
21:8.0.1.1.3.1.1.8	SECTION 803.15	803.15 How will I know if you require more information about my medical device report
21:8.0.1.1.3.1.1.9	SECTION 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
21:8.0.1.1.3.1.1.10	SECTION 803.17	803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me
21:8.0.1.1.3.1.1.11	SECTION 803.18	803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me
21:8.0.1.1.3.1.1.12	SECTION 803.19	803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements
21:8.0.1.1.3.2	SUBPART B	Subpart B - Generally Applicable Requirements for Individual Adverse Event Reports
21:8.0.1.1.3.2.1.1	SECTION 803.20	803.20 How do I complete and submit an individual adverse event report
21:8.0.1.1.3.2.1.2	SECTION 803.21	803.21 Where can I find the reporting codes for adverse events that I use with medical device reports
21:8.0.1.1.3.2.1.3	SECTION 803.22	803.22 What are the circumstances in which I am not required to file a report
21:8.0.1.1.3.2.1.4	SECTION 803.23	803.23 Where can I find information on how to prepare and submit an MDR in electronic format
21:8.0.1.1.3.3	SUBPART C	Subpart C - User Facility Reporting Requirements
21:8.0.1.1.3.3.1.1	SECTION 803.30	803.30 If I am a user facility, what reporting requirements apply to me
21:8.0.1.1.3.3.1.2	SECTION 803.32	803.32 If I am a user facility, what information must I submit in my individual adverse event reports
21:8.0.1.1.3.3.1.3	SECTION 803.33	803.33 If I am a user facility, what must I include when I submit an annual report
21:8.0.1.1.3.4	SUBPART D	Subpart D - Importer Reporting Requirements
21:8.0.1.1.3.4.1.1	SECTION 803.40	803.40 If I am an importer, what reporting requirements apply to me
21:8.0.1.1.3.4.1.2	SECTION 803.42	803.42 If I am an importer, what information must I submit in my individual adverse event reports
21:8.0.1.1.3.5	SUBPART E	Subpart E - Manufacturer Reporting Requirements
21:8.0.1.1.3.5.1.1	SECTION 803.50	803.50 If I am a manufacturer, what reporting requirements apply to me
21:8.0.1.1.3.5.1.2	SECTION 803.52	803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports
21:8.0.1.1.3.5.1.3	SECTION 803.53	803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report
21:8.0.1.1.3.5.1.4	SECTION 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
21:8.0.1.1.3.5.1.5	SECTION 803.58	803.58 Foreign manufacturers.
21:8.0.1.1.4	PART 806	PART 806 - MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
21:8.0.1.1.4.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.4.1.1.1	SECTION 806.1	806.1 Scope.
21:8.0.1.1.4.1.1.2	SECTION 806.2	806.2 Definitions.
21:8.0.1.1.4.2	SUBPART B	Subpart B - Reports and Records
21:8.0.1.1.4.2.1.1	SECTION 806.10	806.10 Reports of corrections and removals.
21:8.0.1.1.4.2.1.2	SECTION 806.20	806.20 Records of corrections and removals not required to be reported.
21:8.0.1.1.4.2.1.3	SECTION 806.30	806.30 FDA access to records.
21:8.0.1.1.4.2.1.4	SECTION 806.40	806.40 Public availability of reports.
21:8.0.1.1.5	PART 807	PART 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
21:8.0.1.1.5.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.5.1.1.1	SECTION 807.3	807.3 Definitions.
21:8.0.1.1.5.2	SUBPART B	Subpart B - Procedures for Device Establishments
21:8.0.1.1.5.2.1.1	SECTION 807.20	807.20 Who must register and submit a device list
21:8.0.1.1.5.2.1.2	SECTION 807.21	807.21 How to register establishments and list devices.
21:8.0.1.1.5.2.1.3	SECTION 807.22	807.22 Times for establishment registration and device listing.
21:8.0.1.1.5.2.1.4	SECTION 807.25	807.25 Information required for device establishment registration and device listing.
21:8.0.1.1.5.2.1.5	SECTION 807.26	807.26 Additional listing information.
21:8.0.1.1.5.2.1.6	SECTION 807.28	807.28 Updating device listing information.
21:8.0.1.1.5.2.1.7	SECTION 807.34	807.34 Summary of requirements for owners or operators granted a waiver from submitting required information electronically.
21:8.0.1.1.5.2.1.8	SECTION 807.35	807.35 Notification of registrant.
21:8.0.1.1.5.2.1.9	SECTION 807.37	807.37 Public availability of establishment registration and device listing information.
21:8.0.1.1.5.2.1.10	SECTION 807.39	807.39 Misbranding by reference to establishment registration or to registration number.
21:8.0.1.1.5.3	SUBPART C	Subpart C - Procedures for Foreign Device Establishments
21:8.0.1.1.5.3.1.1	SECTION 807.40	807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.
21:8.0.1.1.5.3.1.2	SECTION 807.41	807.41 Identification of importers and persons who import or offer for import.
21:8.0.1.1.5.4	SUBPART D	Subpart D - Exemptions
21:8.0.1.1.5.4.1.1	SECTION 807.65	807.65 Exemptions for device establishments.
21:8.0.1.1.5.5	SUBPART E	Subpart E - Premarket Notification Procedures
21:8.0.1.1.5.5.1.1	SECTION 807.81	807.81 When a premarket notification submission is required.
21:8.0.1.1.5.5.1.2	SECTION 807.85	807.85 Exemption from premarket notification.
21:8.0.1.1.5.5.1.3	SECTION 807.87	807.87 Information required in a premarket notification submission.
21:8.0.1.1.5.5.1.4	SECTION 807.90	807.90 Format of a premarket notification submission.
21:8.0.1.1.5.5.1.5	SECTION 807.92	807.92 Content and format of a 510(k) summary.
21:8.0.1.1.5.5.1.6	SECTION 807.93	807.93 Content and format of a 510(k) statement.
21:8.0.1.1.5.5.1.7	SECTION 807.94	807.94 Format of a class III certification.
21:8.0.1.1.5.5.1.8	SECTION 807.95	807.95 Confidentiality of information.
21:8.0.1.1.5.5.1.9	SECTION 807.97	807.97 Misbranding by reference to premarket notification.
21:8.0.1.1.5.5.1.10	SECTION 807.100	807.100 FDA action on a premarket notification.
21:8.0.1.1.6	PART 808	PART 808 - EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
21:8.0.1.1.6.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.6.1.1.1	SECTION 808.1	808.1 Scope.
21:8.0.1.1.6.1.1.2	SECTION 808.3	808.3 Definitions.
21:8.0.1.1.6.1.1.3	SECTION 808.5	808.5 Advisory opinions.
21:8.0.1.1.6.2	SUBPART B	Subpart B - Exemption Procedures
21:8.0.1.1.6.2.1.1	SECTION 808.20	808.20 Application.
21:8.0.1.1.6.2.1.2	SECTION 808.25	808.25 Procedures for processing an application.
21:8.0.1.1.6.2.1.3	SECTION 808.35	808.35 Revocation of an exemption.
21:8.0.1.1.6.3	SUBPART C	Subpart C - Listing of Specific State and Local Exemptions
21:8.0.1.1.6.3.1.1	SECTION 808.53	808.53 Arizona.
21:8.0.1.1.6.3.1.2	SECTION 808.55	808.55 California.
21:8.0.1.1.6.3.1.3	SECTION 808.57	808.57 Connecticut.
21:8.0.1.1.6.3.1.4	SECTION 808.59	808.59 Florida.
21:8.0.1.1.6.3.1.5	SECTION 808.61	808.61 Hawaii.
21:8.0.1.1.6.3.1.6	SECTION 808.67	808.67 Kentucky.
21:8.0.1.1.6.3.1.7	SECTION 808.69	808.69 Maine.
21:8.0.1.1.6.3.1.8	SECTION 808.71	808.71 Massachusetts.
21:8.0.1.1.6.3.1.9	SECTION 808.73	808.73 Minnesota.
21:8.0.1.1.6.3.1.10	SECTION 808.74	808.74 Mississippi.
21:8.0.1.1.6.3.1.11	SECTION 808.77	808.77 Nebraska.
21:8.0.1.1.6.3.1.12	SECTION 808.80	808.80 New Jersey.
21:8.0.1.1.6.3.1.13	SECTION 808.81	808.81 New Mexico.
21:8.0.1.1.6.3.1.14	SECTION 808.82	808.82 New York.
21:8.0.1.1.6.3.1.15	SECTION 808.85	808.85 Ohio.
21:8.0.1.1.6.3.1.16	SECTION 808.87	808.87 Oregon.
21:8.0.1.1.6.3.1.17	SECTION 808.88	808.88 Pennsylvania.
21:8.0.1.1.6.3.1.18	SECTION 808.89	808.89 Rhode Island.
21:8.0.1.1.6.3.1.19	SECTION 808.93	808.93 Texas.
21:8.0.1.1.6.3.1.20	SECTION 808.97	808.97 Washington.
21:8.0.1.1.6.3.1.21	SECTION 808.98	808.98 West Virginia.
21:8.0.1.1.6.3.1.22	SECTION 808.101	808.101 District of Columbia.
21:8.0.1.1.7	PART 809	PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
21:8.0.1.1.7.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.7.1.1.1	SECTION 809.3	809.3 Definitions.
21:8.0.1.1.7.1.1.2	SECTION 809.4	809.4 Confidentiality of submitted information.
21:8.0.1.1.7.2	SUBPART B	Subpart B - Labeling
21:8.0.1.1.7.2.1.1	SECTION 809.10	809.10 Labeling for in vitro diagnostic products.
21:8.0.1.1.7.2.1.2	SECTION 809.11	809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile.
21:8.0.1.1.7.3	SUBPART C	Subpart C - Requirements for Manufacturers and Producers
21:8.0.1.1.7.3.1.1	SECTION 809.20	809.20 General requirements for manufacturers and producers of in vitro diagnostic products.
21:8.0.1.1.7.3.1.2	SECTION 809.30	809.30 Restrictions on the sale, distribution and use of analyte specific reagents.
21:8.0.1.1.7.3.1.3	SECTION 809.40	809.40 Restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.
21:8.0.1.1.8	PART 810	PART 810 - MEDICAL DEVICE RECALL AUTHORITY
21:8.0.1.1.8.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.8.1.1.1	SECTION 810.1	810.1 Scope.
21:8.0.1.1.8.1.1.2	SECTION 810.2	810.2 Definitions.
21:8.0.1.1.8.1.1.3	SECTION 810.3	810.3 Computation of time.
21:8.0.1.1.8.1.1.4	SECTION 810.4	810.4 Service of orders.
21:8.0.1.1.8.2	SUBPART B	Subpart B - Mandatory Medical Device Recall Procedures
21:8.0.1.1.8.2.1.1	SECTION 810.10	810.10 Cease distribution and notification order.
21:8.0.1.1.8.2.1.2	SECTION 810.11	810.11 Regulatory hearing.
21:8.0.1.1.8.2.1.3	SECTION 810.12	810.12 Written request for review of cease distribution and notification order.
21:8.0.1.1.8.2.1.4	SECTION 810.13	810.13 Mandatory recall order.
21:8.0.1.1.8.2.1.5	SECTION 810.14	810.14 Cease distribution and notification or mandatory recall strategy.
21:8.0.1.1.8.2.1.6	SECTION 810.15	810.15 Communications concerning a cease distribution and notification or mandatory recall order.
21:8.0.1.1.8.2.1.7	SECTION 810.16	810.16 Cease distribution and notification or mandatory recall order status reports.
21:8.0.1.1.8.2.1.8	SECTION 810.17	810.17 Termination of a cease distribution and notification or mandatory recall order.
21:8.0.1.1.8.2.1.9	SECTION 810.18	810.18 Public notice.
21:8.0.1.1.9	PART 812	PART 812 - INVESTIGATIONAL DEVICE EXEMPTIONS
21:8.0.1.1.9.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.9.1.1.1	SECTION 812.1	812.1 Scope.
21:8.0.1.1.9.1.1.2	SECTION 812.2	812.2 Applicability.
21:8.0.1.1.9.1.1.3	SECTION 812.3	812.3 Definitions.
21:8.0.1.1.9.1.1.4	SECTION 812.5	812.5 Labeling of investigational devices.
21:8.0.1.1.9.1.1.5	SECTION 812.7	812.7 Prohibition of promotion and other practices.
21:8.0.1.1.9.1.1.6	SECTION 812.10	812.10 Waivers.
21:8.0.1.1.9.1.1.7	SECTION 812.18	812.18 Import and export requirements.
21:8.0.1.1.9.1.1.8	SECTION 812.19	812.19 Address for IDE correspondence.
21:8.0.1.1.9.2	SUBPART B	Subpart B - Application and Administrative Action
21:8.0.1.1.9.2.1.1	SECTION 812.20	812.20 Application.
21:8.0.1.1.9.2.1.2	SECTION 812.25	812.25 Investigational plan.
21:8.0.1.1.9.2.1.3	SECTION 812.27	812.27 Report of prior investigations.
21:8.0.1.1.9.2.1.4	SECTION 812.28	812.28 Acceptance of data from clinical investigations conducted outside the United States.
21:8.0.1.1.9.2.1.5	SECTION 812.30	812.30 FDA action on applications.
21:8.0.1.1.9.2.1.6	SECTION 812.35	812.35 Supplemental applications.
21:8.0.1.1.9.2.1.7	SECTION 812.36	812.36 Treatment use of an investigational device.
21:8.0.1.1.9.2.1.8	SECTION 812.38	812.38 Confidentiality of data and information.
21:8.0.1.1.9.3	SUBPART C	Subpart C - Responsibilities of Sponsors
21:8.0.1.1.9.3.1.1	SECTION 812.40	812.40 General responsibilities of sponsors.
21:8.0.1.1.9.3.1.2	SECTION 812.42	812.42 FDA and IRB approval.
21:8.0.1.1.9.3.1.3	SECTION 812.43	812.43 Selecting investigators and monitors.
21:8.0.1.1.9.3.1.4	SECTION 812.45	812.45 Informing investigators.
21:8.0.1.1.9.3.1.5	SECTION 812.46	812.46 Monitoring investigations.
21:8.0.1.1.9.3.1.6	SECTION 812.47	812.47 Emergency research under § 50.24 of this chapter.
21:8.0.1.1.9.4	SUBPART D	Subpart D - IRB Review and Approval
21:8.0.1.1.9.4.1.1	SECTION 812.60	812.60 IRB composition, duties, and functions.
21:8.0.1.1.9.4.1.2	SECTION 812.62	812.62 IRB approval.
21:8.0.1.1.9.4.1.3	SECTION 812.64	812.64 IRB's continuing review.
21:8.0.1.1.9.4.1.4	SECTION 812.65	812.65 [Reserved]
21:8.0.1.1.9.4.1.5	SECTION 812.66	812.66 Significant risk device determinations.
21:8.0.1.1.9.5	SUBPART E	Subpart E - Responsibilities of Investigators
21:8.0.1.1.9.5.1.1	SECTION 812.100	812.100 General responsibilities of investigators.
21:8.0.1.1.9.5.1.2	SECTION 812.110	812.110 Specific responsibilities of investigators.
21:8.0.1.1.9.5.1.3	SECTION 812.119	812.119 Disqualification of a clinical investigator.
21:8.0.1.1.9.6	SUBPART F	Subpart F [Reserved]
21:8.0.1.1.9.7	SUBPART G	Subpart G - Records and Reports
21:8.0.1.1.9.7.1.1	SECTION 812.140	812.140 Records.
21:8.0.1.1.9.7.1.2	SECTION 812.145	812.145 Inspections.
21:8.0.1.1.9.7.1.3	SECTION 812.150	812.150 Reports.
21:8.0.1.1.10	PART 813	PART 813 [RESERVED]
21:8.0.1.1.11	PART 814	PART 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
21:8.0.1.1.11.1	SUBPART A	Subpart A - General
21:8.0.1.1.11.1.1.1	SECTION 814.1	814.1 Scope.
21:8.0.1.1.11.1.1.2	SECTION 814.2	814.2 Purpose.
21:8.0.1.1.11.1.1.3	SECTION 814.3	814.3 Definitions.
21:8.0.1.1.11.1.1.4	SECTION 814.9	814.9 Confidentiality of data and information in a premarket approval application (PMA) file.
21:8.0.1.1.11.1.1.5	SECTION 814.15	814.15 Research conducted outside the United States.
21:8.0.1.1.11.1.1.6	SECTION 814.17	814.17 Service of orders.
21:8.0.1.1.11.1.1.7	SECTION 814.19	814.19 Product development protocol (PDP).
21:8.0.1.1.11.2	SUBPART B	Subpart B - Premarket Approval Application (PMA)
21:8.0.1.1.11.2.1.1	SECTION 814.20	814.20 Application.
21:8.0.1.1.11.2.1.2	SECTION 814.37	814.37 PMA amendments and resubmitted PMAs.
21:8.0.1.1.11.2.1.3	SECTION 814.39	814.39 PMA supplements.
21:8.0.1.1.11.3	SUBPART C	Subpart C - FDA Action on a PMA
21:8.0.1.1.11.3.1.1	SECTION 814.40	814.40 Time frames for reviewing a PMA.
21:8.0.1.1.11.3.1.2	SECTION 814.42	814.42 Filing a PMA.
21:8.0.1.1.11.3.1.3	SECTION 814.44	814.44 Procedures for review of a PMA.
21:8.0.1.1.11.3.1.4	SECTION 814.45	814.45 Denial of approval of a PMA.
21:8.0.1.1.11.3.1.5	SECTION 814.46	814.46 Withdrawal of approval of a PMA.
21:8.0.1.1.11.3.1.6	SECTION 814.47	814.47 Temporary suspension of approval of a PMA.
21:8.0.1.1.11.4	SUBPART D	Subpart D - Administrative Review [Reserved]
21:8.0.1.1.11.5	SUBPART E	Subpart E - Postapproval Requirements
21:8.0.1.1.11.5.1.1	SECTION 814.80	814.80 General.
21:8.0.1.1.11.5.1.2	SECTION 814.82	814.82 Postapproval requirements.
21:8.0.1.1.11.5.1.3	SECTION 814.84	814.84 Reports.
21:8.0.1.1.11.6	SUBPART F	Subparts F-G [Reserved]
21:8.0.1.1.11.7	SUBPART H	Subpart H - Humanitarian Use Devices
21:8.0.1.1.11.7.1.1	SECTION 814.100	814.100 Purpose and scope.
21:8.0.1.1.11.7.1.2	SECTION 814.102	814.102 Designation of HUD status.
21:8.0.1.1.11.7.1.3	SECTION 814.104	814.104 Original applications.
21:8.0.1.1.11.7.1.4	SECTION 814.106	814.106 HDE amendments and resubmitted HDE's.
21:8.0.1.1.11.7.1.5	SECTION 814.108	814.108 Supplemental applications.
21:8.0.1.1.11.7.1.6	SECTION 814.110	814.110 New indications for use.
21:8.0.1.1.11.7.1.7	SECTION 814.112	814.112 Filing an HDE.
21:8.0.1.1.11.7.1.8	SECTION 814.114	814.114 Timeframes for reviewing an HDE.
21:8.0.1.1.11.7.1.9	SECTION 814.116	814.116 Procedures for review of an HDE.
21:8.0.1.1.11.7.1.10	SECTION 814.118	814.118 Denial of approval or withdrawal of approval of an HDE.
21:8.0.1.1.11.7.1.11	SECTION 814.120	814.120 Temporary suspension of approval of an HDE.
21:8.0.1.1.11.7.1.12	SECTION 814.122	814.122 Confidentiality of data and information.
21:8.0.1.1.11.7.1.13	SECTION 814.124	814.124 Institutional Review Board requirements.
21:8.0.1.1.11.7.1.14	SECTION 814.126	814.126 Postapproval requirements and reports.
21:8.0.1.1.12	PART 820	PART 820 - QUALITY SYSTEM REGULATION
21:8.0.1.1.12.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.12.1.1.1	SECTION 820.1	820.1 Scope.
21:8.0.1.1.12.1.1.2	SECTION 820.3	820.3 Definitions.
21:8.0.1.1.12.1.1.3	SECTION 820.5	820.5 Quality system.
21:8.0.1.1.12.2	SUBPART B	Subpart B - Quality System Requirements
21:8.0.1.1.12.2.1.1	SECTION 820.20	820.20 Management responsibility.
21:8.0.1.1.12.2.1.2	SECTION 820.22	820.22 Quality audit.
21:8.0.1.1.12.2.1.3	SECTION 820.25	820.25 Personnel.
21:8.0.1.1.12.3	SUBPART C	Subpart C - Design Controls
21:8.0.1.1.12.3.1.1	SECTION 820.30	820.30 Design controls.
21:8.0.1.1.12.4	SUBPART D	Subpart D - Document Controls
21:8.0.1.1.12.4.1.1	SECTION 820.40	820.40 Document controls.
21:8.0.1.1.12.5	SUBPART E	Subpart E - Purchasing Controls
21:8.0.1.1.12.5.1.1	SECTION 820.50	820.50 Purchasing controls.
21:8.0.1.1.12.6	SUBPART F	Subpart F - Identification and Traceability
21:8.0.1.1.12.6.1.1	SECTION 820.60	820.60 Identification.
21:8.0.1.1.12.6.1.2	SECTION 820.65	820.65 Traceability.
21:8.0.1.1.12.7	SUBPART G	Subpart G - Production and Process Controls
21:8.0.1.1.12.7.1.1	SECTION 820.70	820.70 Production and process controls.
21:8.0.1.1.12.7.1.2	SECTION 820.72	820.72 Inspection, measuring, and test equipment.
21:8.0.1.1.12.7.1.3	SECTION 820.75	820.75 Process validation.
21:8.0.1.1.12.8	SUBPART H	Subpart H - Acceptance Activities
21:8.0.1.1.12.8.1.1	SECTION 820.80	820.80 Receiving, in-process, and finished device acceptance.
21:8.0.1.1.12.8.1.2	SECTION 820.86	820.86 Acceptance status.
21:8.0.1.1.12.9	SUBPART I	Subpart I - Nonconforming Product
21:8.0.1.1.12.9.1.1	SECTION 820.90	820.90 Nonconforming product.
21:8.0.1.1.12.10	SUBPART J	Subpart J - Corrective and Preventive Action
21:8.0.1.1.12.10.1.1	SECTION 820.100	820.100 Corrective and preventive action.
21:8.0.1.1.12.11	SUBPART K	Subpart K - Labeling and Packaging Control
21:8.0.1.1.12.11.1.1	SECTION 820.120	820.120 Device labeling.
21:8.0.1.1.12.11.1.2	SECTION 820.130	820.130 Device packaging.
21:8.0.1.1.12.12	SUBPART L	Subpart L - Handling, Storage, Distribution, and Installation
21:8.0.1.1.12.12.1.1	SECTION 820.140	820.140 Handling.
21:8.0.1.1.12.12.1.2	SECTION 820.150	820.150 Storage.
21:8.0.1.1.12.12.1.3	SECTION 820.160	820.160 Distribution.
21:8.0.1.1.12.12.1.4	SECTION 820.170	820.170 Installation.
21:8.0.1.1.12.13	SUBPART M	Subpart M - Records
21:8.0.1.1.12.13.1.1	SECTION 820.180	820.180 General requirements.
21:8.0.1.1.12.13.1.2	SECTION 820.181	820.181 Device master record.
21:8.0.1.1.12.13.1.3	SECTION 820.184	820.184 Device history record.
21:8.0.1.1.12.13.1.4	SECTION 820.186	820.186 Quality system record.
21:8.0.1.1.12.13.1.5	SECTION 820.198	820.198 Complaint files.
21:8.0.1.1.12.14	SUBPART N	Subpart N - Servicing
21:8.0.1.1.12.14.1.1	SECTION 820.200	820.200 Servicing.
21:8.0.1.1.12.15	SUBPART O	Subpart O - Statistical Techniques
21:8.0.1.1.12.15.1.1	SECTION 820.250	820.250 Statistical techniques.
21:8.0.1.1.13	PART 821	PART 821 - MEDICAL DEVICE TRACKING REQUIREMENTS
21:8.0.1.1.13.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.13.1.1.1	SECTION 821.1	821.1 Scope.
21:8.0.1.1.13.1.1.2	SECTION 821.2	821.2 Exemptions and variances.
21:8.0.1.1.13.1.1.3	SECTION 821.3	821.3 Definitions.
21:8.0.1.1.13.1.1.4	SECTION 821.4	821.4 Imported devices.
21:8.0.1.1.13.2	SUBPART B	Subpart B - Tracking Requirements
21:8.0.1.1.13.2.1.1	SECTION 821.20	821.20 Devices subject to tracking.
21:8.0.1.1.13.2.1.2	SECTION 821.25	821.25 Device tracking system and content requirements: manufacturer requirements.
21:8.0.1.1.13.3	SUBPART C	Subpart C - Additional Requirements and Responsibilities
21:8.0.1.1.13.3.1.1	SECTION 821.30	821.30 Tracking obligations of persons other than device manufacturers: distributor requirements.
21:8.0.1.1.13.4	SUBPART D	Subpart D - Records and Inspections
21:8.0.1.1.13.4.1.1	SECTION 821.50	821.50 Availability.
21:8.0.1.1.13.4.1.2	SECTION 821.55	821.55 Confidentiality.
21:8.0.1.1.13.4.1.3	SECTION 821.60	821.60 Retention of records.
21:8.0.1.1.14	PART 822	PART 822 - POSTMARKET SURVEILLANCE
21:8.0.1.1.14.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.14.1.1.1	SECTION 822.1	822.1 What does this part cover
21:8.0.1.1.14.1.1.2	SECTION 822.2	822.2 What is the purpose of this part
21:8.0.1.1.14.1.1.3	SECTION 822.3	822.3 How do you define the terms used in this part
21:8.0.1.1.14.1.1.4	SECTION 822.4	822.4 Does this part apply to me
21:8.0.1.1.14.2	SUBPART B	Subpart B - Notification
21:8.0.1.1.14.2.1.1	SECTION 822.5	822.5 How will I know if I must conduct postmarket surveillance
21:8.0.1.1.14.2.1.2	SECTION 822.6	822.6 When will you notify me that I am required to conduct postmarket surveillance
21:8.0.1.1.14.2.1.3	SECTION 822.7	822.7 What should I do if I do not agree that postmarket surveillance is appropriate
21:8.0.1.1.14.3	SUBPART C	Subpart C - Postmarket Surveillance Plan
21:8.0.1.1.14.3.1.1	SECTION 822.8	822.8 When, where, and how must I submit my postmarket surveillance plan
21:8.0.1.1.14.3.1.2	SECTION 822.9	822.9 What must I include in my submission
21:8.0.1.1.14.3.1.3	SECTION 822.10	822.10 What must I include in my surveillance plan
21:8.0.1.1.14.3.1.4	SECTION 822.11	822.11 What should I consider when designing my plan to conduct postmarket surveillance
21:8.0.1.1.14.3.1.5	SECTION 822.12	822.12 Do you have any information that will help me prepare my submission or design my postmarket surveillance plan
21:8.0.1.1.14.3.1.6	SECTION 822.13	822.13 [Reserved]
21:8.0.1.1.14.3.1.7	SECTION 822.14	822.14 May I reference information previously submitted instead of submitting it again
21:8.0.1.1.14.3.1.8	SECTION 822.15	822.15 How long must I conduct postmarket surveillance of my device
21:8.0.1.1.14.4	SUBPART D	Subpart D - FDA Review and Action
21:8.0.1.1.14.4.1.1	SECTION 822.16	822.16 What will you consider in the review of my submission
21:8.0.1.1.14.4.1.2	SECTION 822.17	822.17 How long will your review of my submission take
21:8.0.1.1.14.4.1.3	SECTION 822.18	822.18 How will I be notified of your decision
21:8.0.1.1.14.4.1.4	SECTION 822.19	822.19 What kinds of decisions may you make
21:8.0.1.1.14.4.1.5	SECTION 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
21:8.0.1.1.14.4.1.6	SECTION 822.21	822.21 What must I do if I want to make changes to my postmarket surveillance plan after you have approved it
21:8.0.1.1.14.4.1.7	SECTION 822.22	822.22 What recourse do I have if I do not agree with your decision
21:8.0.1.1.14.4.1.8	SECTION 822.23	822.23 Is the information in my submission considered confidential
21:8.0.1.1.14.5	SUBPART E	Subpart E - Responsibilities of Manufacturers
21:8.0.1.1.14.5.1.1	SECTION 822.24	822.24 What are my responsibilities once I am notified that I am required to conduct postmarket surveillance
21:8.0.1.1.14.5.1.2	SECTION 822.25	822.25 What are my responsibilities after my postmarket surveillance plan has been approved
21:8.0.1.1.14.5.1.3	SECTION 822.26	822.26 If my company changes ownership, what must I do
21:8.0.1.1.14.5.1.4	SECTION 822.27	822.27 If I go out of business, what must I do
21:8.0.1.1.14.5.1.5	SECTION 822.28	822.28 If I stop marketing the device subject to postmarket surveillance, what must I do
21:8.0.1.1.14.6	SUBPART F	Subpart F - Waivers and Exemptions
21:8.0.1.1.14.6.1.1	SECTION 822.29	822.29 May I request a waiver of a specific requirement of this part
21:8.0.1.1.14.6.1.2	SECTION 822.30	822.30 May I request exemption from the requirement to conduct postmarket surveillance
21:8.0.1.1.14.7	SUBPART G	Subpart G - Records and Reports
21:8.0.1.1.14.7.1.1	SECTION 822.31	822.31 What records am I required to keep
21:8.0.1.1.14.7.1.2	SECTION 822.32	822.32 What records are the investigators in my surveillance plan required to keep
21:8.0.1.1.14.7.1.3	SECTION 822.33	822.33 How long must we keep the records
21:8.0.1.1.14.7.1.4	SECTION 822.34	822.34 What must I do with the records if the sponsor of the plan or an investigator in the plan changes
21:8.0.1.1.14.7.1.5	SECTION 822.35	822.35 Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan
21:8.0.1.1.14.7.1.6	SECTION 822.36	822.36 Can you inspect and copy the records related to my postmarket surveillance plan
21:8.0.1.1.14.7.1.7	SECTION 822.37	822.37 Under what circumstances would you inspect records identifying subjects
21:8.0.1.1.14.7.1.8	SECTION 822.38	822.38 What reports must I submit to you
21:8.0.1.1.15	PART 830	PART 830 - UNIQUE DEVICE IDENTIFICATION
21:8.0.1.1.15.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.15.1.1.1	SECTION 830.3	830.3 Definitions.
21:8.0.1.1.15.2	SUBPART B	Subpart B - Requirements for a Unique Device Identifier
21:8.0.1.1.15.2.1.1	SECTION 830.10	830.10 Incorporation by reference.
21:8.0.1.1.15.2.1.2	SECTION 830.20	830.20 Requirements for a unique device identifier.
21:8.0.1.1.15.2.1.3	SECTION 830.40	830.40 Use and discontinuation of a device identifier.
21:8.0.1.1.15.2.1.4	SECTION 830.50	830.50 Changes that require use of a new device identifier.
21:8.0.1.1.15.2.1.5	SECTION 830.60	830.60 Relabeling of a device that is required to bear a unique device identifier.
21:8.0.1.1.15.3	SUBPART C	Subpart C - FDA Accreditation of an Issuing Agency
21:8.0.1.1.15.3.1.1	SECTION 830.100	830.100 FDA accreditation of an issuing agency.
21:8.0.1.1.15.3.1.2	SECTION 830.110	830.110 Application for accreditation as an issuing agency.
21:8.0.1.1.15.3.1.3	SECTION 830.120	830.120 Responsibilities of an FDA-accredited issuing agency.
21:8.0.1.1.15.3.1.4	SECTION 830.130	830.130 Suspension or revocation of the accreditation of an issuing agency.
21:8.0.1.1.15.4	SUBPART D	Subpart D - FDA as an Issuing Agency
21:8.0.1.1.15.4.1.1	SECTION 830.200	830.200 When FDA will act as an issuing agency.
21:8.0.1.1.15.4.1.2	SECTION 830.210	830.210 Eligibility for use of FDA as an issuing agency.
21:8.0.1.1.15.4.1.3	SECTION 830.220	830.220 Termination of FDA service as an issuing agency.
21:8.0.1.1.15.5	SUBPART E	Subpart E - Global Unique Device Identification Database
21:8.0.1.1.15.5.1.1	SECTION 830.300	830.300 Devices subject to device identification data submission requirements.
21:8.0.1.1.15.5.1.2	SECTION 830.310	830.310 Information required for unique device identification.
21:8.0.1.1.15.5.1.3	SECTION 830.320	830.320 Submission of unique device identification information.
21:8.0.1.1.15.5.1.4	SECTION 830.330	830.330 Times for submission of unique device identification information.
21:8.0.1.1.15.5.1.5	SECTION 830.340	830.340 Voluntary submission of ancillary device identification information.
21:8.0.1.1.15.5.1.6	SECTION 830.350	830.350 Correction of information submitted to the Global Unique Device Identification Database.
21:8.0.1.1.15.5.1.7	SECTION 830.360	830.360 Records to be maintained by the labeler.
21:8.0.1.1.16	PART 860	PART 860 - MEDICAL DEVICE CLASSIFICATION PROCEDURES
21:8.0.1.1.16.1	SUBPART A	Subpart A - General
21:8.0.1.1.16.1.1.1	SECTION 860.1	860.1 Scope.
21:8.0.1.1.16.1.1.2	SECTION 860.3	860.3 Definitions.
21:8.0.1.1.16.1.1.3	SECTION 860.5	860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification.
21:8.0.1.1.16.1.1.4	SECTION 860.7	860.7 Determination of safety and effectiveness.
21:8.0.1.1.16.1.1.5	SECTION 860.10	860.10 Implants and life-supporting or life-sustaining devices.
21:8.0.1.1.16.1.1.6	SECTION 860.15	860.15 Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.2	SUBPART B	Subpart B - Classification
21:8.0.1.1.16.2.1.1	SECTION 860.84	860.84 Classification procedures for “preamendments devices.”
21:8.0.1.1.16.2.1.2	SECTION 860.90	860.90 Consultation with panels.
21:8.0.1.1.16.3	SUBPART C	Subpart C - Reclassification
21:8.0.1.1.16.3.1.1	SECTION 860.120	860.120 General.
21:8.0.1.1.16.3.1.2	SECTION 860.123	860.123 Reclassification petition: Content and form.
21:8.0.1.1.16.3.1.3	SECTION 860.125	860.125 Consultation with panels.
21:8.0.1.1.16.3.1.4	SECTION 860.130	860.130 General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.3.1.5	SECTION 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.
21:8.0.1.1.16.3.1.6	SECTION 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.
21:8.0.1.1.16.3.1.7	SECTION 860.134	860.134 Procedures for reclassification of “postamendments devices” under section 513(f)(3) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.16.3.1.8	SECTION 860.136	860.136 Procedures for transitional products under section 520(l) of the Federal Food, Drug, and Cosmetic Act.
21:8.0.1.1.17	PART 861	PART 861 - PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
21:8.0.1.1.17.1	SUBPART A	Subpart A - General
21:8.0.1.1.17.1.1.1	SECTION 861.1	861.1 Purpose and scope.
21:8.0.1.1.17.1.1.2	SECTION 861.5	861.5 Statement of policy.
21:8.0.1.1.17.1.1.3	SECTION 861.7	861.7 Contents of standards.
21:8.0.1.1.17.2	SUBPART B	Subpart B - Procedures for Performance Standards Development and Publication
21:8.0.1.1.17.2.1.1	SECTION 861.20	861.20 Summary of standards development process.
21:8.0.1.1.17.2.1.2	SECTION 861.24	861.24 Existing standard as a proposed standard.
21:8.0.1.1.17.2.1.3	SECTION 861.30	861.30 Development of standards.
21:8.0.1.1.17.2.1.4	SECTION 861.34	861.34 Amendment or revocation of a standard.
21:8.0.1.1.17.2.1.5	SECTION 861.36	861.36 Effective dates.
21:8.0.1.1.17.2.1.6	SECTION 861.38	861.38 Standards advisory committees.
21:8.0.1.1.18	PART 862	PART 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
21:8.0.1.1.18.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.18.1.1.1	SECTION 862.1	862.1 Scope.
21:8.0.1.1.18.1.1.2	SECTION 862.2	862.2 Regulation of calibrators.
21:8.0.1.1.18.1.1.3	SECTION 862.3	862.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.18.1.1.4	SECTION 862.9	862.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.18.2	SUBPART B	Subpart B - Clinical Chemistry Test Systems
21:8.0.1.1.18.2.1.1	SECTION 862.1020	862.1020 Acid phosphatase (total or prostatic) test system.
21:8.0.1.1.18.2.1.2	SECTION 862.1025	862.1025 Adrenocorticotropic hormone (ACTH) test system.
21:8.0.1.1.18.2.1.3	SECTION 862.1030	862.1030 Alanine amino transferase (ALT/SGPT) test system.
21:8.0.1.1.18.2.1.4	SECTION 862.1035	862.1035 Albumin test system.
21:8.0.1.1.18.2.1.5	SECTION 862.1040	862.1040 Aldolase test system.
21:8.0.1.1.18.2.1.6	SECTION 862.1045	862.1045 Aldosterone test system.
21:8.0.1.1.18.2.1.7	SECTION 862.1050	862.1050 Alkaline phosphatase or isoenzymes test system.
21:8.0.1.1.18.2.1.8	SECTION 862.1055	862.1055 Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
21:8.0.1.1.18.2.1.9	SECTION 862.1060	862.1060 Delta-aminolevulinic acid test system.
21:8.0.1.1.18.2.1.10	SECTION 862.1065	862.1065 Ammonia test system.
21:8.0.1.1.18.2.1.11	SECTION 862.1070	862.1070 Amylase test system.
21:8.0.1.1.18.2.1.12	SECTION 862.1075	862.1075 Androstenedione test system.
21:8.0.1.1.18.2.1.13	SECTION 862.1080	862.1080 Androsterone test system.
21:8.0.1.1.18.2.1.14	SECTION 862.1085	862.1085 Angiotensin I and renin test system.
21:8.0.1.1.18.2.1.15	SECTION 862.1090	862.1090 Angiotensin converting enzyme (A.C.E.) test system.
21:8.0.1.1.18.2.1.16	SECTION 862.1095	862.1095 Ascorbic acid test system.
21:8.0.1.1.18.2.1.17	SECTION 862.1100	862.1100 Aspartate amino transferase (AST/SGOT) test system.
21:8.0.1.1.18.2.1.18	SECTION 862.1110	862.1110 Bilirubin (total or direct) test system.
21:8.0.1.1.18.2.1.19	SECTION 862.1113	862.1113 Bilirubin (total and unbound) in the neonate test system.
21:8.0.1.1.18.2.1.20	SECTION 862.1115	862.1115 Urinary bilirubin and its conjugates (nonquantitative) test system.
21:8.0.1.1.18.2.1.21	SECTION 862.1117	862.1117 B-type natriuretic peptide test system.
21:8.0.1.1.18.2.1.22	SECTION 862.1118	862.1118 Biotinidase test system.
21:8.0.1.1.18.2.1.23	SECTION 862.1120	862.1120 Blood gases (PCO2, PO2) and blood pH test system.
21:8.0.1.1.18.2.1.24	SECTION 862.1130	862.1130 Blood volume test system.
21:8.0.1.1.18.2.1.25	SECTION 862.1135	862.1135 C-peptides of proinsulin test system.
21:8.0.1.1.18.2.1.26	SECTION 862.1140	862.1140 Calcitonin test system.
21:8.0.1.1.18.2.1.27	SECTION 862.1145	862.1145 Calcium test system.
21:8.0.1.1.18.2.1.28	SECTION 862.1150	862.1150 Calibrator.
21:8.0.1.1.18.2.1.29	SECTION 862.1155	862.1155 Human chorionic gonadotropin (HCG) test system.
21:8.0.1.1.18.2.1.30	SECTION 862.1160	862.1160 Bicarbonate/carbon dioxide test system.
21:8.0.1.1.18.2.1.31	SECTION 862.1163	862.1163 Cardiac allograft gene expression profiling test system.
21:8.0.1.1.18.2.1.32	SECTION 862.1165	862.1165 Catecholamines (total) test system.
21:8.0.1.1.18.2.1.33	SECTION 862.1170	862.1170 Chloride test system.
21:8.0.1.1.18.2.1.34	SECTION 862.1175	862.1175 Cholesterol (total) test system.
21:8.0.1.1.18.2.1.35	SECTION 862.1177	862.1177 Cholylglycine test system.
21:8.0.1.1.18.2.1.36	SECTION 862.1180	862.1180 Chymotrypsin test system.
21:8.0.1.1.18.2.1.37	SECTION 862.1185	862.1185 Compound S (11-deoxycortisol) test system.
21:8.0.1.1.18.2.1.38	SECTION 862.1187	862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
21:8.0.1.1.18.2.1.39	SECTION 862.1190	862.1190 Copper test system.
21:8.0.1.1.18.2.1.40	SECTION 862.1195	862.1195 Corticoids test system.
21:8.0.1.1.18.2.1.41	SECTION 862.1200	862.1200 Corticosterone test system.
21:8.0.1.1.18.2.1.42	SECTION 862.1205	862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
21:8.0.1.1.18.2.1.43	SECTION 862.1210	862.1210 Creatine test system.
21:8.0.1.1.18.2.1.44	SECTION 862.1215	862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
21:8.0.1.1.18.2.1.45	SECTION 862.1220	862.1220 Acute kidney injury test system.
21:8.0.1.1.18.2.1.46	SECTION 862.1225	862.1225 Creatinine test system.
21:8.0.1.1.18.2.1.47	SECTION 862.1230	862.1230 Cyclic AMP test system.
21:8.0.1.1.18.2.1.48	SECTION 862.1235	862.1235 Cyclosporine test system.
21:8.0.1.1.18.2.1.49	SECTION 862.1240	862.1240 Cystine test system.
21:8.0.1.1.18.2.1.50	SECTION 862.1245	862.1245 Dehydroepiandrosterone (free and sulfate) test system.
21:8.0.1.1.18.2.1.51	SECTION 862.1250	862.1250 Desoxycorticosterone test system.
21:8.0.1.1.18.2.1.52	SECTION 862.1255	862.1255 2,3-Diphosphoglyceric acid test system.
21:8.0.1.1.18.2.1.53	SECTION 862.1260	862.1260 Estradiol test system.
21:8.0.1.1.18.2.1.54	SECTION 862.1265	862.1265 Estriol test system.
21:8.0.1.1.18.2.1.55	SECTION 862.1270	862.1270 Estrogens (total, in pregnancy) test system.
21:8.0.1.1.18.2.1.56	SECTION 862.1275	862.1275 Estrogens (total, nonpregnancy) test system.
21:8.0.1.1.18.2.1.57	SECTION 862.1280	862.1280 Estrone test system.
21:8.0.1.1.18.2.1.58	SECTION 862.1285	862.1285 Etiocholanolone test system.
21:8.0.1.1.18.2.1.59	SECTION 862.1290	862.1290 Fatty acids test system.
21:8.0.1.1.18.2.1.60	SECTION 862.1295	862.1295 Folic acid test system.
21:8.0.1.1.18.2.1.61	SECTION 862.1300	862.1300 Follicle-stimulating hormone test system.
21:8.0.1.1.18.2.1.62	SECTION 862.1305	862.1305 Formiminoglutamic acid (FIGLU) test system.
21:8.0.1.1.18.2.1.63	SECTION 862.1310	862.1310 Galactose test system.
21:8.0.1.1.18.2.1.64	SECTION 862.1315	862.1315 Galactose-1-phosphate uridyl transferase test system.
21:8.0.1.1.18.2.1.65	SECTION 862.1320	862.1320 Gastric acidity test system.
21:8.0.1.1.18.2.1.66	SECTION 862.1325	862.1325 Gastrin test system.
21:8.0.1.1.18.2.1.67	SECTION 862.1330	862.1330 Globulin test system.
21:8.0.1.1.18.2.1.68	SECTION 862.1335	862.1335 Glucagon test system.
21:8.0.1.1.18.2.1.69	SECTION 862.1340	862.1340 Urinary glucose (nonquantitative) test system.
21:8.0.1.1.18.2.1.70	SECTION 862.1345	862.1345 Glucose test system.
21:8.0.1.1.18.2.1.71	SECTION 862.1350	862.1350 Continuous glucose monitor secondary display.
21:8.0.1.1.18.2.1.72	SECTION 862.1358	862.1358 Insulin therapy adjustment device.
21:8.0.1.1.18.2.1.73	SECTION 862.1360	862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
21:8.0.1.1.18.2.1.74	SECTION 862.1365	862.1365 Glutathione test system.
21:8.0.1.1.18.2.1.75	SECTION 862.1370	862.1370 Human growth hormone test system.
21:8.0.1.1.18.2.1.76	SECTION 862.1373	862.1373 Hemoglobin A1c test system.
21:8.0.1.1.18.2.1.77	SECTION 862.1375	862.1375 Histidine test system.
21:8.0.1.1.18.2.1.78	SECTION 862.1377	862.1377 Urinary homocystine (nonquantitative) test system.
21:8.0.1.1.18.2.1.79	SECTION 862.1380	862.1380 Hydroxybutyric dehydrogenase test system.
21:8.0.1.1.18.2.1.80	SECTION 862.1385	862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.
21:8.0.1.1.18.2.1.81	SECTION 862.1390	862.1390 5-Hydroxyindole acetic acid/serotonin test system.
21:8.0.1.1.18.2.1.82	SECTION 862.1395	862.1395 17-Hydroxyprogesterone test system.
21:8.0.1.1.18.2.1.83	SECTION 862.1400	862.1400 Hydroxyproline test system.
21:8.0.1.1.18.2.1.84	SECTION 862.1405	862.1405 Immunoreactive insulin test system.
21:8.0.1.1.18.2.1.85	SECTION 862.1410	862.1410 Iron (non-heme) test system.
21:8.0.1.1.18.2.1.86	SECTION 862.1415	862.1415 Iron-binding capacity test system.
21:8.0.1.1.18.2.1.87	SECTION 862.1420	862.1420 Isocitric dehydrogenase test system.
21:8.0.1.1.18.2.1.88	SECTION 862.1430	862.1430 17-Ketosteroids test system.
21:8.0.1.1.18.2.1.89	SECTION 862.1435	862.1435 Ketones (nonquantitative) test system.
21:8.0.1.1.18.2.1.90	SECTION 862.1440	862.1440 Lactate dehydrogenase test system.
21:8.0.1.1.18.2.1.91	SECTION 862.1445	862.1445 Lactate dehydrogenase isoenzymes test system.
21:8.0.1.1.18.2.1.92	SECTION 862.1450	862.1450 Lactic acid test system.
21:8.0.1.1.18.2.1.93	SECTION 862.1455	862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.
21:8.0.1.1.18.2.1.94	SECTION 862.1460	862.1460 Leucine aminopeptidase test system.
21:8.0.1.1.18.2.1.95	SECTION 862.1465	862.1465 Lipase test system.
21:8.0.1.1.18.2.1.96	SECTION 862.1470	862.1470 Lipid (total) test system.
21:8.0.1.1.18.2.1.97	SECTION 862.1475	862.1475 Lipoprotein test system.
21:8.0.1.1.18.2.1.98	SECTION 862.1485	862.1485 Luteinizing hormone test system.
21:8.0.1.1.18.2.1.99	SECTION 862.1490	862.1490 Lysozyme (muramidase) test system.
21:8.0.1.1.18.2.1.100	SECTION 862.1495	862.1495 Magnesium test system.
21:8.0.1.1.18.2.1.101	SECTION 862.1500	862.1500 Malic dehydrogenase test system.
21:8.0.1.1.18.2.1.102	SECTION 862.1505	862.1505 Mucopolysaccharides (nonquantitative) test system.
21:8.0.1.1.18.2.1.103	SECTION 862.1509	862.1509 Methylmalonic acid (nonquantitative) test system.
21:8.0.1.1.18.2.1.104	SECTION 862.1510	862.1510 Nitrite (nonquantitative) test system.
21:8.0.1.1.18.2.1.105	SECTION 862.1515	862.1515 Nitrogen (amino-nitrogen) test system.
21:8.0.1.1.18.2.1.106	SECTION 862.1520	862.1520 5′-Nucleotidase test system.
21:8.0.1.1.18.2.1.107	SECTION 862.1530	862.1530 Plasma oncometry test system.
21:8.0.1.1.18.2.1.108	SECTION 862.1535	862.1535 Ornithine carbamyl transferase test system.
21:8.0.1.1.18.2.1.109	SECTION 862.1540	862.1540 Osmolality test system.
21:8.0.1.1.18.2.1.110	SECTION 862.1542	862.1542 Oxalate test system.
21:8.0.1.1.18.2.1.111	SECTION 862.1545	862.1545 Parathyroid hormone test system.
21:8.0.1.1.18.2.1.112	SECTION 862.1550	862.1550 Urinary pH (nonquantitative) test system.
21:8.0.1.1.18.2.1.113	SECTION 862.1555	862.1555 Phenylalanine test system.
21:8.0.1.1.18.2.1.114	SECTION 862.1560	862.1560 Urinary phenylketones (nonquantitative) test system.
21:8.0.1.1.18.2.1.115	SECTION 862.1565	862.1565 6-Phosphogluconate dehydrogenase test system.
21:8.0.1.1.18.2.1.116	SECTION 862.1570	862.1570 Phosphohexose isomerase test system.
21:8.0.1.1.18.2.1.117	SECTION 862.1575	862.1575 Phospholipid test system.
21:8.0.1.1.18.2.1.118	SECTION 862.1580	862.1580 Phosphorus (inorganic) test system.
21:8.0.1.1.18.2.1.119	SECTION 862.1585	862.1585 Human placental lactogen test system.
21:8.0.1.1.18.2.1.120	SECTION 862.1590	862.1590 Porphobilinogen test system.
21:8.0.1.1.18.2.1.121	SECTION 862.1595	862.1595 Porphyrins test system.
21:8.0.1.1.18.2.1.122	SECTION 862.1600	862.1600 Potassium test system.
21:8.0.1.1.18.2.1.123	SECTION 862.1605	862.1605 Pregnanediol test system.
21:8.0.1.1.18.2.1.124	SECTION 862.1610	862.1610 Pregnanetriol test system.
21:8.0.1.1.18.2.1.125	SECTION 862.1615	862.1615 Pregnenolone test system.
21:8.0.1.1.18.2.1.126	SECTION 862.1620	862.1620 Progesterone test system.
21:8.0.1.1.18.2.1.127	SECTION 862.1625	862.1625 Prolactin (lactogen) test system.
21:8.0.1.1.18.2.1.128	SECTION 862.1630	862.1630 Protein (fractionation) test system.
21:8.0.1.1.18.2.1.129	SECTION 862.1635	862.1635 Total protein test system.
21:8.0.1.1.18.2.1.130	SECTION 862.1640	862.1640 Protein-bound iodine test system.
21:8.0.1.1.18.2.1.131	SECTION 862.1645	862.1645 Urinary protein or albumin (nonquantitative) test system.
21:8.0.1.1.18.2.1.132	SECTION 862.1650	862.1650 Pyruvate kinase test system.
21:8.0.1.1.18.2.1.133	SECTION 862.1655	862.1655 Pyruvic acid test system.
21:8.0.1.1.18.2.1.134	SECTION 862.1660	862.1660 Quality control material (assayed and unassayed).
21:8.0.1.1.18.2.1.135	SECTION 862.1665	862.1665 Sodium test system.
21:8.0.1.1.18.2.1.136	SECTION 862.1670	862.1670 Sorbitol dehydrogenase test system.
21:8.0.1.1.18.2.1.137	SECTION 862.1675	862.1675 Blood specimen collection device.
21:8.0.1.1.18.2.1.138	SECTION 862.1678	862.1678 Tacrolimus test system.
21:8.0.1.1.18.2.1.139	SECTION 862.1680	862.1680 Testosterone test system.
21:8.0.1.1.18.2.1.140	SECTION 862.1685	862.1685 Thyroxine-binding globulin test system.
21:8.0.1.1.18.2.1.141	SECTION 862.1690	862.1690 Thyroid stimulating hormone test system.
21:8.0.1.1.18.2.1.142	SECTION 862.1695	862.1695 Free thyroxine test system.
21:8.0.1.1.18.2.1.143	SECTION 862.1700	862.1700 Total thyroxine test system.
21:8.0.1.1.18.2.1.144	SECTION 862.1705	862.1705 Triglyceride test system.
21:8.0.1.1.18.2.1.145	SECTION 862.1710	862.1710 Total triiodothyronine test system.
21:8.0.1.1.18.2.1.146	SECTION 862.1715	862.1715 Triiodothyronine uptake test system.
21:8.0.1.1.18.2.1.147	SECTION 862.1720	862.1720 Triose phosphate isomerase test system.
21:8.0.1.1.18.2.1.148	SECTION 862.1725	862.1725 Trypsin test system.
21:8.0.1.1.18.2.1.149	SECTION 862.1730	862.1730 Free tyrosine test system.
21:8.0.1.1.18.2.1.150	SECTION 862.1770	862.1770 Urea nitrogen test system.
21:8.0.1.1.18.2.1.151	SECTION 862.1775	862.1775 Uric acid test system.
21:8.0.1.1.18.2.1.152	SECTION 862.1780	862.1780 Urinary calculi (stones) test system.
21:8.0.1.1.18.2.1.153	SECTION 862.1785	862.1785 Urinary urobilinogen (nonquantitative) test system.
21:8.0.1.1.18.2.1.154	SECTION 862.1790	862.1790 Uroporphyrin test system.
21:8.0.1.1.18.2.1.155	SECTION 862.1795	862.1795 Vanilmandelic acid test system.
21:8.0.1.1.18.2.1.156	SECTION 862.1805	862.1805 Vitamin A test system.
21:8.0.1.1.18.2.1.157	SECTION 862.1810	862.1810 Vitamin B12 test system.
21:8.0.1.1.18.2.1.158	SECTION 862.1815	862.1815 Vitamin E test system.
21:8.0.1.1.18.2.1.159	SECTION 862.1820	862.1820 Xylose test system.
21:8.0.1.1.18.2.1.160	SECTION 862.1825	862.1825 Vitamin D test system.
21:8.0.1.1.18.2.1.161	SECTION 862.1840	862.1840 Total 25-hydroxyvitamin D mass spectrometry test system.
21:8.0.1.1.18.3	SUBPART C	Subpart C - Clinical Laboratory Instruments
21:8.0.1.1.18.3.1.1	SECTION 862.2050	862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
21:8.0.1.1.18.3.1.2	SECTION 862.2100	862.2100 Calculator/data processing module for clinical use.
21:8.0.1.1.18.3.1.3	SECTION 862.2120	862.2120 Continuous glucose monitor data management system.
21:8.0.1.1.18.3.1.4	SECTION 862.2140	862.2140 Centrifugal chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.5	SECTION 862.2150	862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.6	SECTION 862.2160	862.2160 Discrete photometric chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.7	SECTION 862.2170	862.2170 Micro chemistry analyzer for clinical use.
21:8.0.1.1.18.3.1.8	SECTION 862.2230	862.2230 Chromatographic separation material for clinical use.
21:8.0.1.1.18.3.1.9	SECTION 862.2250	862.2250 Gas liquid chromatography system for clinical use.
21:8.0.1.1.18.3.1.10	SECTION 862.2260	862.2260 High pressure liquid chromatography system for clinical use.
21:8.0.1.1.18.3.1.11	SECTION 862.2265	862.2265 High throughput genomic sequence analyzer for clinical use.
21:8.0.1.1.18.3.1.12	SECTION 862.2270	862.2270 Thin-layer chromatography system for clinical use.
21:8.0.1.1.18.3.1.13	SECTION 862.2300	862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
21:8.0.1.1.18.3.1.14	SECTION 862.2310	862.2310 Clinical sample concentrator.
21:8.0.1.1.18.3.1.15	SECTION 862.2320	862.2320 Beta or gamma counter for clinical use.
21:8.0.1.1.18.3.1.16	SECTION 862.2400	862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
21:8.0.1.1.18.3.1.17	SECTION 862.2485	862.2485 Electrophoresis apparatus for clinical use.
21:8.0.1.1.18.3.1.18	SECTION 862.2500	862.2500 Enzyme analyzer for clinical use.
21:8.0.1.1.18.3.1.19	SECTION 862.2540	862.2540 Flame emission photometer for clinical use.
21:8.0.1.1.18.3.1.20	SECTION 862.2560	862.2560 Fluorometer for clinical use.
21:8.0.1.1.18.3.1.21	SECTION 862.2570	862.2570 Instrumentation for clinical multiplex test systems.
21:8.0.1.1.18.3.1.22	SECTION 862.2680	862.2680 Microtitrator for clinical use.
21:8.0.1.1.18.3.1.23	SECTION 862.2700	862.2700 Nephelometer for clinical use.
21:8.0.1.1.18.3.1.24	SECTION 862.2720	862.2720 Plasma oncometer for clinical use.
21:8.0.1.1.18.3.1.25	SECTION 862.2730	862.2730 Osmometer for clinical use.
21:8.0.1.1.18.3.1.26	SECTION 862.2750	862.2750 Pipetting and diluting system for clinical use.
21:8.0.1.1.18.3.1.27	SECTION 862.2800	862.2800 Refractometer for clinical use.
21:8.0.1.1.18.3.1.28	SECTION 862.2850	862.2850 Atomic absorption spectrophotometer for clinical use.
21:8.0.1.1.18.3.1.29	SECTION 862.2860	862.2860 Mass spectrometer for clinical use.
21:8.0.1.1.18.3.1.30	SECTION 862.2900	862.2900 Automated urinalysis system.
21:8.0.1.1.18.3.1.31	SECTION 862.2920	862.2920 Plasma viscometer for clinical use.
21:8.0.1.1.18.4	SUBPART D	Subpart D - Clinical Toxicology Test Systems
21:8.0.1.1.18.4.1.1	SECTION 862.3030	862.3030 Acetaminophen test system.
21:8.0.1.1.18.4.1.2	SECTION 862.3035	862.3035 Amikacin test system.
21:8.0.1.1.18.4.1.3	SECTION 862.3040	862.3040 Alcohol test system.
21:8.0.1.1.18.4.1.4	SECTION 862.3050	862.3050 Breath-alcohol test system.
21:8.0.1.1.18.4.1.5	SECTION 862.3080	862.3080 Breath nitric oxide test system.
21:8.0.1.1.18.4.1.6	SECTION 862.3100	862.3100 Amphetamine test system.
21:8.0.1.1.18.4.1.7	SECTION 862.3110	862.3110 Antimony test system.
21:8.0.1.1.18.4.1.8	SECTION 862.3120	862.3120 Arsenic test system.
21:8.0.1.1.18.4.1.9	SECTION 862.3150	862.3150 Barbiturate test system.
21:8.0.1.1.18.4.1.10	SECTION 862.3170	862.3170 Benzodiazepine test system.
21:8.0.1.1.18.4.1.11	SECTION 862.3200	862.3200 Clinical toxicology calibrator.
21:8.0.1.1.18.4.1.12	SECTION 862.3220	862.3220 Carbon monoxide test system.
21:8.0.1.1.18.4.1.13	SECTION 862.3240	862.3240 Cholinesterase test system.
21:8.0.1.1.18.4.1.14	SECTION 862.3250	862.3250 Cocaine and cocaine metabolite test system.
21:8.0.1.1.18.4.1.15	SECTION 862.3270	862.3270 Codeine test system.
21:8.0.1.1.18.4.1.16	SECTION 862.3280	862.3280 Clinical toxicology control material.
21:8.0.1.1.18.4.1.17	SECTION 862.3300	862.3300 Digitoxin test system.
21:8.0.1.1.18.4.1.18	SECTION 862.3320	862.3320 Digoxin test system.
21:8.0.1.1.18.4.1.19	SECTION 862.3350	862.3350 Diphenylhydantoin test system.
21:8.0.1.1.18.4.1.20	SECTION 862.3360	862.3360 Drug metabolizing enzyme genotyping system.
21:8.0.1.1.18.4.1.21	SECTION 862.3380	862.3380 Ethosuximide test system.
21:8.0.1.1.18.4.1.22	SECTION 862.3450	862.3450 Gentamicin test system.
21:8.0.1.1.18.4.1.23	SECTION 862.3520	862.3520 Kanamycin test system.
21:8.0.1.1.18.4.1.24	SECTION 862.3550	862.3550 Lead test system.
21:8.0.1.1.18.4.1.25	SECTION 862.3555	862.3555 Lidocaine test system.
21:8.0.1.1.18.4.1.26	SECTION 862.3560	862.3560 Lithium test system.
21:8.0.1.1.18.4.1.27	SECTION 862.3580	862.3580 Lysergic acid diethylamide (LSD) test system.
21:8.0.1.1.18.4.1.28	SECTION 862.3590	862.3590 Meprobamate test system.
21:8.0.1.1.18.4.1.29	SECTION 862.3600	862.3600 Mercury test system.
21:8.0.1.1.18.4.1.30	SECTION 862.3610	862.3610 Methamphetamine test system.
21:8.0.1.1.18.4.1.31	SECTION 862.3620	862.3620 Methadone test system.
21:8.0.1.1.18.4.1.32	SECTION 862.3630	862.3630 Methaqualone test system.
21:8.0.1.1.18.4.1.33	SECTION 862.3640	862.3640 Morphine test system.
21:8.0.1.1.18.4.1.34	SECTION 862.3645	862.3645 Neuroleptic drugs radioreceptor assay test system.
21:8.0.1.1.18.4.1.35	SECTION 862.3650	862.3650 Opiate test system.
21:8.0.1.1.18.4.1.36	SECTION 862.3652	862.3652 Organophosphate test system.
21:8.0.1.1.18.4.1.37	SECTION 862.3660	862.3660 Phenobarbital test system.
21:8.0.1.1.18.4.1.38	SECTION 862.3670	862.3670 Phenothiazine test system.
21:8.0.1.1.18.4.1.39	SECTION 862.3680	862.3680 Primidone test system.
21:8.0.1.1.18.4.1.40	SECTION 862.3700	862.3700 Propoxyphene test system.
21:8.0.1.1.18.4.1.41	SECTION 862.3750	862.3750 Quinine test system.
21:8.0.1.1.18.4.1.42	SECTION 862.3800	862.3800 Reagents for molecular diagnostic instrument test systems.
21:8.0.1.1.18.4.1.43	SECTION 862.3830	862.3830 Salicylate test system.
21:8.0.1.1.18.4.1.44	SECTION 862.3840	862.3840 Sirolimus test system.
21:8.0.1.1.18.4.1.45	SECTION 862.3850	862.3850 Sulfonamide test system.
21:8.0.1.1.18.4.1.46	SECTION 862.3870	862.3870 Cannabinoid test system.
21:8.0.1.1.18.4.1.47	SECTION 862.3880	862.3880 Theophylline test system.
21:8.0.1.1.18.4.1.48	SECTION 862.3900	862.3900 Tobramycin test system.
21:8.0.1.1.18.4.1.49	SECTION 862.3910	862.3910 Tricyclic antidepressant drugs test system.
21:8.0.1.1.18.4.1.50	SECTION 862.3950	862.3950 Vancomycin test system.
21:8.0.1.1.19	PART 864	PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
21:8.0.1.1.19.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.19.1.1.1	SECTION 864.1	864.1 Scope.
21:8.0.1.1.19.1.1.2	SECTION 864.3	864.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.19.1.1.3	SECTION 864.9	864.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.19.2	SUBPART B	Subpart B - Biological Stains
21:8.0.1.1.19.2.1.1	SECTION 864.1850	864.1850 Dye and chemical solution stains.
21:8.0.1.1.19.2.1.2	SECTION 864.1860	864.1860 Immunohistochemistry reagents and kits.
21:8.0.1.1.19.2.1.3	SECTION 864.1865	864.1865 Cervical intraepithelial neoplasia (CIN) test system.
21:8.0.1.1.19.2.1.4	SECTION 864.1866	864.1866 Lynch syndrome test systems.
21:8.0.1.1.19.2.1.5	SECTION 864.1870	864.1870 Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
21:8.0.1.1.19.3	SUBPART C	Subpart C - Cell And Tissue Culture Products
21:8.0.1.1.19.3.1.1	SECTION 864.2220	864.2220 Synthetic cell and tissue culture media and components.
21:8.0.1.1.19.3.1.2	SECTION 864.2240	864.2240 Cell and tissue culture supplies and equipment.
21:8.0.1.1.19.3.1.3	SECTION 864.2260	864.2260 Chromosome culture kit.
21:8.0.1.1.19.3.1.4	SECTION 864.2280	864.2280 Cultured animal and human cells.
21:8.0.1.1.19.3.1.5	SECTION 864.2360	864.2360 Mycoplasma detection media and components.
21:8.0.1.1.19.3.1.6	SECTION 864.2800	864.2800 Animal and human sera.
21:8.0.1.1.19.3.1.7	SECTION 864.2875	864.2875 Balanced salt solutions or formulations.
21:8.0.1.1.19.4	SUBPART D	Subpart D - Pathology Instrumentation and Accessories
21:8.0.1.1.19.4.1.1	SECTION 864.3010	864.3010 Tissue processing equipment.
21:8.0.1.1.19.4.1.2	SECTION 864.3250	864.3250 Specimen transport and storage container.
21:8.0.1.1.19.4.1.3	SECTION 864.3260	864.3260 OTC test sample collection systems for drugs of abuse testing.
21:8.0.1.1.19.4.1.4	SECTION 864.3300	864.3300 Cytocentrifuge.
21:8.0.1.1.19.4.1.5	SECTION 864.3400	864.3400 Device for sealing microsections.
21:8.0.1.1.19.4.1.6	SECTION 864.3600	864.3600 Microscopes and accessories.
21:8.0.1.1.19.4.1.7	SECTION 864.3700	864.3700 Whole slide imaging system.
21:8.0.1.1.19.4.1.8	SECTION 864.3800	864.3800 Automated slide stainer.
21:8.0.1.1.19.4.1.9	SECTION 864.3875	864.3875 Automated tissue processor.
21:8.0.1.1.19.5	SUBPART E	Subpart E - Specimen Preparation Reagents
21:8.0.1.1.19.5.1.1	SECTION 864.4010	864.4010 General purpose reagent.
21:8.0.1.1.19.5.1.2	SECTION 864.4020	864.4020 Analyte specific reagents.
21:8.0.1.1.19.5.1.3	SECTION 864.4400	864.4400 Enzyme preparations.
21:8.0.1.1.19.6	SUBPART F	Subpart F - Automated and Semi-Automated Hematology Devices
21:8.0.1.1.19.6.1.1	SECTION 864.5200	864.5200 Automated cell counter.
21:8.0.1.1.19.6.1.2	SECTION 864.5220	864.5220 Automated differential cell counter.
21:8.0.1.1.19.6.1.3	SECTION 864.5240	864.5240 Automated blood cell diluting apparatus.
21:8.0.1.1.19.6.1.4	SECTION 864.5260	864.5260 Automated cell-locating device.
21:8.0.1.1.19.6.1.5	SECTION 864.5300	864.5300 Red cell indices device.
21:8.0.1.1.19.6.1.6	SECTION 864.5350	864.5350 Microsedimentation centrifuge.
21:8.0.1.1.19.6.1.7	SECTION 864.5400	864.5400 Coagulation instrument.
21:8.0.1.1.19.6.1.8	SECTION 864.5425	864.5425 Multipurpose system for in vitro coagulation studies.
21:8.0.1.1.19.6.1.9	SECTION 864.5600	864.5600 Automated hematocrit instrument.
21:8.0.1.1.19.6.1.10	SECTION 864.5620	864.5620 Automated hemoglobin system.
21:8.0.1.1.19.6.1.11	SECTION 864.5680	864.5680 Automated heparin analyzer.
21:8.0.1.1.19.6.1.12	SECTION 864.5700	864.5700 Automated platelet aggregation system.
21:8.0.1.1.19.6.1.13	SECTION 864.5800	864.5800 Automated sedimentation rate device.
21:8.0.1.1.19.6.1.14	SECTION 864.5850	864.5850 Automated slide spinner.
21:8.0.1.1.19.6.1.15	SECTION 864.5950	864.5950 Blood volume measuring device.
21:8.0.1.1.19.7	SUBPART G	Subpart G - Manual Hematology Devices
21:8.0.1.1.19.7.1.1	SECTION 864.6100	864.6100 Bleeding time device.
21:8.0.1.1.19.7.1.2	SECTION 864.6150	864.6150 Capillary blood collection tube.
21:8.0.1.1.19.7.1.3	SECTION 864.6160	864.6160 Manual blood cell counting device.
21:8.0.1.1.19.7.1.4	SECTION 864.6400	864.6400 Hematocrit measuring device.
21:8.0.1.1.19.7.1.5	SECTION 864.6550	864.6550 Occult blood test.
21:8.0.1.1.19.7.1.6	SECTION 864.6600	864.6600 Osmotic fragility test.
21:8.0.1.1.19.7.1.7	SECTION 864.6650	864.6650 Platelet adhesion test.
21:8.0.1.1.19.7.1.8	SECTION 864.6675	864.6675 Platelet aggregometer.
21:8.0.1.1.19.7.1.9	SECTION 864.6700	864.6700 Erythrocyte sedimentation rate test.
21:8.0.1.1.19.8	SUBPART H	Subpart H - Hematology Kits and Packages
21:8.0.1.1.19.8.1.1	SECTION 864.7010	864.7010 Flow cytometric test system for hematopoietic neoplasms.
21:8.0.1.1.19.8.1.2	SECTION 864.7040	864.7040 Adenosine triphosphate release assay.
21:8.0.1.1.19.8.1.3	SECTION 864.7060	864.7060 Antithrombin III assay.
21:8.0.1.1.19.8.1.4	SECTION 864.7100	864.7100 Red blood cell enzyme assay.
21:8.0.1.1.19.8.1.5	SECTION 864.7140	864.7140 Activated whole blood clotting time tests.
21:8.0.1.1.19.8.1.6	SECTION 864.7250	864.7250 Erythropoietin assay.
21:8.0.1.1.19.8.1.7	SECTION 864.7275	864.7275 Euglobulin lysis time tests.
21:8.0.1.1.19.8.1.8	SECTION 864.7280	864.7280 Factor V Leiden DNA mutation detection systems.
21:8.0.1.1.19.8.1.9	SECTION 864.7290	864.7290 Factor deficiency test.
21:8.0.1.1.19.8.1.10	SECTION 864.7300	864.7300 Fibrin monomer paracoagulation test.
21:8.0.1.1.19.8.1.11	SECTION 864.7320	864.7320 Fibrinogen/fibrin degradation products assay.
21:8.0.1.1.19.8.1.12	SECTION 864.7340	864.7340 Fibrinogen determination system.
21:8.0.1.1.19.8.1.13	SECTION 864.7360	864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay.
21:8.0.1.1.19.8.1.14	SECTION 864.7375	864.7375 Glutathione reductase assay.
21:8.0.1.1.19.8.1.15	SECTION 864.7400	864.7400 Hemoglobin A2 assay.
21:8.0.1.1.19.8.1.16	SECTION 864.7415	864.7415 Abnormal hemoglobin assay.
21:8.0.1.1.19.8.1.17	SECTION 864.7425	864.7425 Carboxyhemoglobin assay.
21:8.0.1.1.19.8.1.18	SECTION 864.7440	864.7440 Electrophoretic hemoglobin analysis system.
21:8.0.1.1.19.8.1.19	SECTION 864.7455	864.7455 Fetal hemoglobin assay.
21:8.0.1.1.19.8.1.20	SECTION 864.7470	864.7470 Glycosylated hemoglobin assay.
21:8.0.1.1.19.8.1.21	SECTION 864.7490	864.7490 Sulfhemoglobin assay.
21:8.0.1.1.19.8.1.22	SECTION 864.7500	864.7500 Whole blood hemoglobin assays.
21:8.0.1.1.19.8.1.23	SECTION 864.7525	864.7525 Heparin assay.
21:8.0.1.1.19.8.1.24	SECTION 864.7660	864.7660 Leukocyte alkaline phosphatase test.
21:8.0.1.1.19.8.1.25	SECTION 864.7675	864.7675 Leukocyte peroxidase test.
21:8.0.1.1.19.8.1.26	SECTION 864.7695	864.7695 Platelet factor 4 radioimmunoassay.
21:8.0.1.1.19.8.1.27	SECTION 864.7720	864.7720 Prothrombin consumption test.
21:8.0.1.1.19.8.1.28	SECTION 864.7735	864.7735 Prothrombin-proconvertin test and thrombotest.
21:8.0.1.1.19.8.1.29	SECTION 864.7750	864.7750 Prothrombin time test.
21:8.0.1.1.19.8.1.30	SECTION 864.7825	864.7825 Sickle cell test.
21:8.0.1.1.19.8.1.31	SECTION 864.7875	864.7875 Thrombin time test.
21:8.0.1.1.19.8.1.32	SECTION 864.7900	864.7900 Thromboplastin generation test.
21:8.0.1.1.19.8.1.33	SECTION 864.7925	864.7925 Partial thromboplastin time tests.
21:8.0.1.1.19.9	SUBPART I	Subpart I - Hematology Reagents
21:8.0.1.1.19.9.1.1	SECTION 864.8100	864.8100 Bothrops atrox reagent.
21:8.0.1.1.19.9.1.2	SECTION 864.8150	864.8150 Calibrator for cell indices.
21:8.0.1.1.19.9.1.3	SECTION 864.8165	864.8165 Calibrator for hemoglobin or hematocrit measurement.
21:8.0.1.1.19.9.1.4	SECTION 864.8175	864.8175 Calibrator for platelet counting.
21:8.0.1.1.19.9.1.5	SECTION 864.8185	864.8185 Calibrator for red cell and white cell counting.
21:8.0.1.1.19.9.1.6	SECTION 864.8200	864.8200 Blood cell diluent.
21:8.0.1.1.19.9.1.7	SECTION 864.8500	864.8500 Lymphocyte separation medium.
21:8.0.1.1.19.9.1.8	SECTION 864.8540	864.8540 Red cell lysing reagent.
21:8.0.1.1.19.9.1.9	SECTION 864.8625	864.8625 Hematology quality control mixture.
21:8.0.1.1.19.9.1.10	SECTION 864.8950	864.8950 Russell viper venom reagent.
21:8.0.1.1.19.10	SUBPART J	Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products
21:8.0.1.1.19.10.1.1	SECTION 864.9050	864.9050 Blood bank supplies.
21:8.0.1.1.19.10.1.2	SECTION 864.9100	864.9100 Empty container for the collection and processing of blood and blood components.
21:8.0.1.1.19.10.1.3	SECTION 864.9125	864.9125 Vacuum-assisted blood collection system.
21:8.0.1.1.19.10.1.4	SECTION 864.9145	864.9145 Processing system for frozen blood.
21:8.0.1.1.19.10.1.5	SECTION 864.9160	864.9160 Blood group substances of nonhuman origin for in vitro diagnostic use.
21:8.0.1.1.19.10.1.6	SECTION 864.9165	864.9165 Blood establishment computer software and accessories.
21:8.0.1.1.19.10.1.7	SECTION 864.9175	864.9175 Automated blood grouping and antibody test system.
21:8.0.1.1.19.10.1.8	SECTION 864.9185	864.9185 Blood grouping view box.
21:8.0.1.1.19.10.1.9	SECTION 864.9195	864.9195 Blood mixing devices and blood weighing devices.
21:8.0.1.1.19.10.1.10	SECTION 864.9205	864.9205 Blood and plasma warming device.
21:8.0.1.1.19.10.1.11	SECTION 864.9225	864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use.
21:8.0.1.1.19.10.1.12	SECTION 864.9245	864.9245 Automated blood cell separator.
21:8.0.1.1.19.10.1.13	SECTION 864.9275	864.9275 Blood bank centrifuge for in vitro diagnostic use.
21:8.0.1.1.19.10.1.14	SECTION 864.9285	864.9285 Automated cell-washing centrifuge for immuno-hematology.
21:8.0.1.1.19.10.1.15	SECTION 864.9300	864.9300 Automated Coombs test systems.
21:8.0.1.1.19.10.1.16	SECTION 864.9320	864.9320 Copper sulfate solution for specific gravity determinations.
21:8.0.1.1.19.10.1.17	SECTION 864.9400	864.9400 Stabilized enzyme solution.
21:8.0.1.1.19.10.1.18	SECTION 864.9550	864.9550 Lectins and protectins.
21:8.0.1.1.19.10.1.19	SECTION 864.9575	864.9575 Environmental chamber for storage of platelet concentrate.
21:8.0.1.1.19.10.1.20	SECTION 864.9600	864.9600 Potentiating media for in vitro diagnostic use.
21:8.0.1.1.19.10.1.21	SECTION 864.9650	864.9650 Quality control kit for blood banking reagents.
21:8.0.1.1.19.10.1.22	SECTION 864.9700	864.9700 Blood storage refrigerator and blood storage freezer.
21:8.0.1.1.19.10.1.23	SECTION 864.9750	864.9750 Heat-sealing device.
21:8.0.1.1.19.10.1.24	SECTION 864.9875	864.9875 Transfer set.
21:8.0.1.1.19.11	SUBPART K	Subpart K - Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
21:8.0.1.1.19.11.1.1	SECTION 864.9900	864.9900 Cord blood processing system and storage container.
21:8.0.1.1.20	PART 866	PART 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES
21:8.0.1.1.20.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.20.1.1.1	SECTION 866.1	866.1 Scope.
21:8.0.1.1.20.1.1.2	SECTION 866.3	866.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.20.1.1.3	SECTION 866.9	866.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.20.2	SUBPART B	Subpart B - Diagnostic Devices
21:8.0.1.1.20.2.1.1	SECTION 866.1620	866.1620 Antimicrobial susceptibility test disc.
21:8.0.1.1.20.2.1.2	SECTION 866.1640	866.1640 Antimicrobial susceptibility test powder.
21:8.0.1.1.20.2.1.3	SECTION 866.1645	866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
21:8.0.1.1.20.2.1.4	SECTION 866.1700	866.1700 Culture medium for antimicrobial susceptibility tests.
21:8.0.1.1.20.3	SUBPART C	Subpart C - Microbiology Devices
21:8.0.1.1.20.3.1.1	SECTION 866.2050	866.2050 Staphylococcal typing bacteriophage.
21:8.0.1.1.20.3.1.2	SECTION 866.2120	866.2120 Anaerobic chamber.
21:8.0.1.1.20.3.1.3	SECTION 866.2160	866.2160 Coagulase plasma.
21:8.0.1.1.20.3.1.4	SECTION 866.2170	866.2170 Automated colony counter.
21:8.0.1.1.20.3.1.5	SECTION 866.2180	866.2180 Manual colony counter.
21:8.0.1.1.20.3.1.6	SECTION 866.2190	866.2190 Automated image assessment system for microbial colonies on solid culture media.
21:8.0.1.1.20.3.1.7	SECTION 866.2300	866.2300 Multipurpose culture medium.
21:8.0.1.1.20.3.1.8	SECTION 866.2320	866.2320 Differential culture medium.
21:8.0.1.1.20.3.1.9	SECTION 866.2330	866.2330 Enriched culture medium.
21:8.0.1.1.20.3.1.10	SECTION 866.2350	866.2350 Microbiological assay culture medium.
21:8.0.1.1.20.3.1.11	SECTION 866.2360	866.2360 Selective culture medium.
21:8.0.1.1.20.3.1.12	SECTION 866.2390	866.2390 Transport culture medium.
21:8.0.1.1.20.3.1.13	SECTION 866.2410	866.2410 Culture medium for pathogenic Neisseria spp.
21:8.0.1.1.20.3.1.14	SECTION 866.2420	866.2420 Oxidase screening test for gonorrhea.
21:8.0.1.1.20.3.1.15	SECTION 866.2440	866.2440 Automated medium dispensing and stacking device.
21:8.0.1.1.20.3.1.16	SECTION 866.2450	866.2450 Supplement for culture media.
21:8.0.1.1.20.3.1.17	SECTION 866.2480	866.2480 Quality control kit for culture media.
21:8.0.1.1.20.3.1.18	SECTION 866.2500	866.2500 Microtiter diluting and dispensing device.
21:8.0.1.1.20.3.1.19	SECTION 866.2540	866.2540 Microbiological incubator.
21:8.0.1.1.20.3.1.20	SECTION 866.2560	866.2560 Microbial growth monitor.
21:8.0.1.1.20.3.1.21	SECTION 866.2580	866.2580 Gas-generating device.
21:8.0.1.1.20.3.1.22	SECTION 866.2600	866.2600 Wood's fluorescent lamp.
21:8.0.1.1.20.3.1.23	SECTION 866.2660	866.2660 Microorganism differentiation and identification device.
21:8.0.1.1.20.3.1.24	SECTION 866.2680	866.2680 Streptococcus spp. nucleic acid-based assay.
21:8.0.1.1.20.3.1.25	SECTION 866.2850	866.2850 Automated zone reader.
21:8.0.1.1.20.3.1.26	SECTION 866.2900	866.2900 Microbiological specimen collection and transport device.
21:8.0.1.1.20.4	SUBPART D	Subpart D - Serological Reagents
21:8.0.1.1.20.4.1.1	SECTION 866.3010	866.3010 Acinetobacter calcoaceticus serological reagents.
21:8.0.1.1.20.4.1.2	SECTION 866.3020	866.3020 Adenovirus serological reagents.
21:8.0.1.1.20.4.1.3	SECTION 866.3035	866.3035 Arizona spp. serological reagents.
21:8.0.1.1.20.4.1.4	SECTION 866.3040	866.3040 Aspergillus spp. serological reagents.
21:8.0.1.1.20.4.1.5	SECTION 866.3045	866.3045 In vitro diagnostic device for Bacillus spp. detection.
21:8.0.1.1.20.4.1.6	SECTION 866.3050	866.3050 Beta-glucan serological assays.
21:8.0.1.1.20.4.1.7	SECTION 866.3060	866.3060 Blastomyces dermatitidis serological reagents.
21:8.0.1.1.20.4.1.8	SECTION 866.3065	866.3065 Bordetella spp. serological reagents.
21:8.0.1.1.20.4.1.9	SECTION 866.3085	866.3085 Brucella spp. serological reagents.
21:8.0.1.1.20.4.1.10	SECTION 866.3110	866.3110 Campylobacter fetus serological reagents.
21:8.0.1.1.20.4.1.11	SECTION 866.3120	866.3120 Chlamydia serological reagents.
21:8.0.1.1.20.4.1.12	SECTION 866.3125	866.3125 Citrobacter spp. serological reagents.
21:8.0.1.1.20.4.1.13	SECTION 866.3130	866.3130 Clostridium difficile toxin gene amplification assay.
21:8.0.1.1.20.4.1.14	SECTION 866.3135	866.3135 Coccidioides immitis serological reagents.
21:8.0.1.1.20.4.1.15	SECTION 866.3140	866.3140 Corynebacterium spp. serological reagents.
21:8.0.1.1.20.4.1.16	SECTION 866.3145	866.3145 Coxsackievirus serological reagents.
21:8.0.1.1.20.4.1.17	SECTION 866.3165	866.3165 Cryptococcus neoformans serological reagents.
21:8.0.1.1.20.4.1.18	SECTION 866.3175	866.3175 Cytomegalovirus serological reagents.
21:8.0.1.1.20.4.1.19	SECTION 866.3200	866.3200 Echinococcus spp. serological reagents.
21:8.0.1.1.20.4.1.20	SECTION 866.3205	866.3205 Echovirus serological reagents.
21:8.0.1.1.20.4.1.21	SECTION 866.3210	866.3210 Endotoxin assay.
21:8.0.1.1.20.4.1.22	SECTION 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.
21:8.0.1.1.20.4.1.23	SECTION 866.3220	866.3220 Entamoeba histolytica serological reagents.
21:8.0.1.1.20.4.1.24	SECTION 866.3225	866.3225 Enterovirus nucleic acid assay.
21:8.0.1.1.20.4.1.25	SECTION 866.3235	866.3235 Epstein-Barr virus serological reagents.
21:8.0.1.1.20.4.1.26	SECTION 866.3240	866.3240 Equine encephalomyelitis virus serological reagents.
21:8.0.1.1.20.4.1.27	SECTION 866.3250	866.3250 Erysipelothrix rhusiopathiae serological reagents.
21:8.0.1.1.20.4.1.28	SECTION 866.3255	866.3255 Escherichia coli serological reagents.
21:8.0.1.1.20.4.1.29	SECTION 866.3270	866.3270 Flavobacterium spp. serological reagents.
21:8.0.1.1.20.4.1.30	SECTION 866.3280	866.3280 Francisella tularensis serological reagents.
21:8.0.1.1.20.4.1.31	SECTION 866.3290	866.3290 Gonococcal antibody test (GAT).
21:8.0.1.1.20.4.1.32	SECTION 866.3300	866.3300 Haemophilus spp. serological reagents.
21:8.0.1.1.20.4.1.33	SECTION 866.3305	866.3305 Herpes simplex virus serological assays.
21:8.0.1.1.20.4.1.34	SECTION 866.3309	866.3309 Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
21:8.0.1.1.20.4.1.35	SECTION 866.3310	866.3310 Hepatitis A virus (HAV) serological assays.
21:8.0.1.1.20.4.1.36	SECTION 866.3320	866.3320 Histoplasma capsulatum serological reagents.
21:8.0.1.1.20.4.1.37	SECTION 866.3328	866.3328 Influenza virus antigen detection test system.
21:8.0.1.1.20.4.1.38	SECTION 866.3330	866.3330 Influenza virus serological reagents.
21:8.0.1.1.20.4.1.39	SECTION 866.3332	866.3332 Reagents for detection of specific novel influenza A viruses.
21:8.0.1.1.20.4.1.40	SECTION 866.3336	866.3336 John Cunningham Virus serological reagents.
21:8.0.1.1.20.4.1.41	SECTION 866.3340	866.3340 Klebsiella spp. serological reagents.
21:8.0.1.1.20.4.1.42	SECTION 866.3350	866.3350 Leptospira spp. serological reagents.
21:8.0.1.1.20.4.1.43	SECTION 866.3355	866.3355 Listeria spp. serological reagents.
21:8.0.1.1.20.4.1.44	SECTION 866.3360	866.3360 Lymphocytic choriomeningitis virus serological reagents.
21:8.0.1.1.20.4.1.45	SECTION 866.3361	866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.
21:8.0.1.1.20.4.1.46	SECTION 866.3365	866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
21:8.0.1.1.20.4.1.47	SECTION 866.3370	866.3370 Mycobacterium tuberculosis immunofluorescent reagents.
21:8.0.1.1.20.4.1.48	SECTION 866.3372	866.3372 Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens.
21:8.0.1.1.20.4.1.49	SECTION 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.
21:8.0.1.1.20.4.1.50	SECTION 866.3375	866.3375 Mycoplasma spp. serological reagents.
21:8.0.1.1.20.4.1.51	SECTION 866.3380	866.3380 Mumps virus serological reagents.
21:8.0.1.1.20.4.1.52	SECTION 866.3390	866.3390 Neisseria spp. direct serological test reagents.
21:8.0.1.1.20.4.1.53	SECTION 866.3395	866.3395 Norovirus serological reagents.
21:8.0.1.1.20.4.1.54	SECTION 866.3400	866.3400 Parainfluenza virus serological reagents.
21:8.0.1.1.20.4.1.55	SECTION 866.3402	866.3402 Plasmodium species antigen detection assays.
21:8.0.1.1.20.4.1.56	SECTION 866.3405	866.3405 Poliovirus serological reagents.
21:8.0.1.1.20.4.1.57	SECTION 866.3410	866.3410 Proteus spp. (Weil-Felix) serological reagents.
21:8.0.1.1.20.4.1.58	SECTION 866.3415	866.3415 Pseudomonas spp. serological reagents.
21:8.0.1.1.20.4.1.59	SECTION 866.3460	866.3460 Rabiesvirus immunofluorescent reagents.
21:8.0.1.1.20.4.1.60	SECTION 866.3470	866.3470 Reovirus serological reagents.
21:8.0.1.1.20.4.1.61	SECTION 866.3480	866.3480 Respiratory syncytial virus serological reagents.
21:8.0.1.1.20.4.1.62	SECTION 866.3490	866.3490 Rhinovirus serological reagents.
21:8.0.1.1.20.4.1.63	SECTION 866.3500	866.3500 Rickettsia serological reagents.
21:8.0.1.1.20.4.1.64	SECTION 866.3510	866.3510 Rubella virus serological reagents.
21:8.0.1.1.20.4.1.65	SECTION 866.3520	866.3520 Rubeola (measles) virus serological reagents.
21:8.0.1.1.20.4.1.66	SECTION 866.3550	866.3550 Salmonella spp. serological reagents.
21:8.0.1.1.20.4.1.67	SECTION 866.3600	866.3600 Schistosoma spp. serological reagents.
21:8.0.1.1.20.4.1.68	SECTION 866.3630	866.3630 Serratia spp. serological reagents.
21:8.0.1.1.20.4.1.69	SECTION 866.3660	866.3660 Shigella spp. serological reagents.
21:8.0.1.1.20.4.1.70	SECTION 866.3680	866.3680 Sporothrix schenckii serological reagents.
21:8.0.1.1.20.4.1.71	SECTION 866.3700	866.3700 Staphylococcus aureus serological reagents.
21:8.0.1.1.20.4.1.72	SECTION 866.3720	866.3720 Streptococcus spp. exoenzyme reagents.
21:8.0.1.1.20.4.1.73	SECTION 866.3740	866.3740 Streptococcus spp. serological reagents.
21:8.0.1.1.20.4.1.74	SECTION 866.3780	866.3780 Toxoplasma gondii serological reagents.
21:8.0.1.1.20.4.1.75	SECTION 866.3820	866.3820 Treponema pallidum nontreponemal test reagents.
21:8.0.1.1.20.4.1.76	SECTION 866.3830	866.3830 Treponema pallidum treponemal test reagents.
21:8.0.1.1.20.4.1.77	SECTION 866.3850	866.3850 Trichinella spiralis serological reagents.
21:8.0.1.1.20.4.1.78	SECTION 866.3860	866.3860 Trichomonas vaginalis nucleic acid assay.
21:8.0.1.1.20.4.1.79	SECTION 866.3870	866.3870 Trypanosoma spp. serological reagents.
21:8.0.1.1.20.4.1.80	SECTION 866.3900	866.3900 Varicella-zoster virus serological reagents.
21:8.0.1.1.20.4.1.81	SECTION 866.3920	866.3920 Assayed quality control material for clinical microbiology assays.
21:8.0.1.1.20.4.1.82	SECTION 866.3930	866.3930 Vibrio cholerae serological reagents.
21:8.0.1.1.20.4.1.83	SECTION 866.3940	866.3940 West Nile virus serological reagents.
21:8.0.1.1.20.4.1.84	SECTION 866.3945	866.3945 Dengue virus serological reagents.
21:8.0.1.1.20.4.1.85	SECTION 866.3946	866.3946 Dengue virus nucleic acid amplification test reagents.
21:8.0.1.1.20.4.1.86	SECTION 866.3950	866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
21:8.0.1.1.20.4.1.87	SECTION 866.3955	866.3955 Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology.
21:8.0.1.1.20.4.1.88	SECTION 866.3960	866.3960 Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
21:8.0.1.1.20.4.1.89	SECTION 866.3970	866.3970 Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid.
21:8.0.1.1.20.4.1.90	SECTION 866.3980	866.3980 Respiratory viral panel multiplex nucleic acid assay.
21:8.0.1.1.20.4.1.91	SECTION 866.3985	866.3985 Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
21:8.0.1.1.20.4.1.92	SECTION 866.3990	866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
21:8.0.1.1.20.5	SUBPART E	Subpart E - Immunology Laboratory Equipment and Reagents
21:8.0.1.1.20.5.1.1	SECTION 866.4070	866.4070 RNA Preanalytical Systems.
21:8.0.1.1.20.5.1.2	SECTION 866.4100	866.4100 Complement reagent.
21:8.0.1.1.20.5.1.3	SECTION 866.4500	866.4500 Immunoelectrophoresis equipment.
21:8.0.1.1.20.5.1.4	SECTION 866.4520	866.4520 Immunofluorometer equipment.
21:8.0.1.1.20.5.1.5	SECTION 866.4540	866.4540 Immunonephelometer equipment.
21:8.0.1.1.20.5.1.6	SECTION 866.4600	866.4600 Ouchterlony agar plate.
21:8.0.1.1.20.5.1.7	SECTION 866.4700	866.4700 Automated fluorescence in situ hybridization (FISH) enumeration systems.
21:8.0.1.1.20.5.1.8	SECTION 866.4750	866.4750 Automated indirect immunofluorescence microscope and software-assisted system.
21:8.0.1.1.20.5.1.9	SECTION 866.4800	866.4800 Radial immunodiffusion plate.
21:8.0.1.1.20.5.1.10	SECTION 866.4830	866.4830 Rocket immunoelectrophoresis equipment.
21:8.0.1.1.20.5.1.11	SECTION 866.4900	866.4900 Support gel.
21:8.0.1.1.20.6	SUBPART F	Subpart F - Immunological Test Systems
21:8.0.1.1.20.6.1.1	SECTION 866.5040	866.5040 Albumin immunological test system.
21:8.0.1.1.20.6.1.2	SECTION 866.5060	866.5060 Prealbumin immunological test system.
21:8.0.1.1.20.6.1.3	SECTION 866.5065	866.5065 Human allotypic marker immunological test system.
21:8.0.1.1.20.6.1.4	SECTION 866.5080	866.5080 Alpha-1-antichymotrypsin immunological test system.
21:8.0.1.1.20.6.1.5	SECTION 866.5090	866.5090 Antimitochondrial antibody immunological test system.
21:8.0.1.1.20.6.1.6	SECTION 866.5100	866.5100 Antinuclear antibody immunological test system.
21:8.0.1.1.20.6.1.7	SECTION 866.5110	866.5110 Antiparietal antibody immunological test system.
21:8.0.1.1.20.6.1.8	SECTION 866.5120	866.5120 Antismooth muscle antibody immunological test system.
21:8.0.1.1.20.6.1.9	SECTION 866.5130	866.5130 Alpha-1-antitrypsin immunological test system.
21:8.0.1.1.20.6.1.10	SECTION 866.5150	866.5150 Bence-Jones proteins immunological test system.
21:8.0.1.1.20.6.1.11	SECTION 866.5160	866.5160 Beta-globulin immunological test system.
21:8.0.1.1.20.6.1.12	SECTION 866.5170	866.5170 Breast milk immunological test system.
21:8.0.1.1.20.6.1.13	SECTION 866.5180	866.5180 Fecal calprotectin immunological test system.
21:8.0.1.1.20.6.1.14	SECTION 866.5200	866.5200 Carbonic anhydrase B and C immunological test system.
21:8.0.1.1.20.6.1.15	SECTION 866.5210	866.5210 Ceruloplasmin immunological test system.
21:8.0.1.1.20.6.1.16	SECTION 866.5220	866.5220 Cohn fraction II immunological test system.
21:8.0.1.1.20.6.1.17	SECTION 866.5230	866.5230 Colostrum immunological test system.
21:8.0.1.1.20.6.1.18	SECTION 866.5240	866.5240 Complement components immunological test system.
21:8.0.1.1.20.6.1.19	SECTION 866.5250	866.5250 Complement C1 inhibitor (inactivator) immunological test system.
21:8.0.1.1.20.6.1.20	SECTION 866.5260	866.5260 Complement C3b inactivator immunological test system.
21:8.0.1.1.20.6.1.21	SECTION 866.5270	866.5270 C-reactive protein immunological test system.
21:8.0.1.1.20.6.1.22	SECTION 866.5320	866.5320 Properdin factor B immunological test system.
21:8.0.1.1.20.6.1.23	SECTION 866.5330	866.5330 Factor XIII, A, S, immunological test system.
21:8.0.1.1.20.6.1.24	SECTION 866.5340	866.5340 Ferritin immunological test system.
21:8.0.1.1.20.6.1.25	SECTION 866.5350	866.5350 Fibrinopeptide A immunological test system.
21:8.0.1.1.20.6.1.26	SECTION 866.5360	866.5360 Cohn fraction IV immunological test system.
21:8.0.1.1.20.6.1.27	SECTION 866.5370	866.5370 Cohn fraction V immunological test system.
21:8.0.1.1.20.6.1.28	SECTION 866.5380	866.5380 Free secretory component immunological test system.
21:8.0.1.1.20.6.1.29	SECTION 866.5400	866.5400 Alpha-globulin immunological test system.
21:8.0.1.1.20.6.1.30	SECTION 866.5420	866.5420 Alpha-1-glycoproteins immunological test system.
21:8.0.1.1.20.6.1.31	SECTION 866.5425	866.5425 Alpha-2-glycoproteins immunological test system.
21:8.0.1.1.20.6.1.32	SECTION 866.5430	866.5430 Beta-2-glycoprotein I immunological test system.
21:8.0.1.1.20.6.1.33	SECTION 866.5440	866.5440 Beta-2-glycoprotein III immunological test system.
21:8.0.1.1.20.6.1.34	SECTION 866.5460	866.5460 Haptoglobin immunological test system.
21:8.0.1.1.20.6.1.35	SECTION 866.5470	866.5470 Hemoglobin immunological test system.
21:8.0.1.1.20.6.1.36	SECTION 866.5490	866.5490 Hemopexin immunological test system.
21:8.0.1.1.20.6.1.37	SECTION 866.5500	866.5500 Hypersensitivity pneumonitis immunological test system.
21:8.0.1.1.20.6.1.38	SECTION 866.5510	866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
21:8.0.1.1.20.6.1.39	SECTION 866.5520	866.5520 Immunoglobulin G (Fab fragment specific) immunological test system.
21:8.0.1.1.20.6.1.40	SECTION 866.5530	866.5530 Immunoglobulin G (Fc fragment specific) immunological test system.
21:8.0.1.1.20.6.1.41	SECTION 866.5540	866.5540 Immunoglobulin G (Fd fragment specific) immunological test system.
21:8.0.1.1.20.6.1.42	SECTION 866.5550	866.5550 Immunoglobulin (light chain specific) immunological test system.
21:8.0.1.1.20.6.1.43	SECTION 866.5560	866.5560 Lactic dehydrogenase immunological test system.
21:8.0.1.1.20.6.1.44	SECTION 866.5570	866.5570 Lactoferrin immunological test system.
21:8.0.1.1.20.6.1.45	SECTION 866.5580	866.5580 Alpha-1-lipoprotein immunological test system.
21:8.0.1.1.20.6.1.46	SECTION 866.5590	866.5590 Lipoprotein X immunological test system.
21:8.0.1.1.20.6.1.47	SECTION 866.5600	866.5600 Low-density lipoprotein immunological test system.
21:8.0.1.1.20.6.1.48	SECTION 866.5620	866.5620 Alpha-2-macroglobulin immunological test system.
21:8.0.1.1.20.6.1.49	SECTION 866.5630	866.5630 Beta-2-microglobulin immunological test system.
21:8.0.1.1.20.6.1.50	SECTION 866.5640	866.5640 Infectious mononucleosis immunological test system.
21:8.0.1.1.20.6.1.51	SECTION 866.5660	866.5660 Multiple autoantibodies immunological test system.
21:8.0.1.1.20.6.1.52	SECTION 866.5665	866.5665 Aquaporin-4 autoantibody immunological test system.
21:8.0.1.1.20.6.1.53	SECTION 866.5670	866.5670 Zinc transporter 8 autoantibody immunological test system.
21:8.0.1.1.20.6.1.54	SECTION 866.5680	866.5680 Myoglobin immunological test system.
21:8.0.1.1.20.6.1.55	SECTION 866.5700	866.5700 Whole human plasma or serum immunological test system.
21:8.0.1.1.20.6.1.56	SECTION 866.5715	866.5715 Plasminogen immunological test system.
21:8.0.1.1.20.6.1.57	SECTION 866.5735	866.5735 Prothrombin immunological test system.
21:8.0.1.1.20.6.1.58	SECTION 866.5750	866.5750 Radioallergosorbent (RAST) immunological test system.
21:8.0.1.1.20.6.1.59	SECTION 866.5760	866.5760 Tryptase test system.
21:8.0.1.1.20.6.1.60	SECTION 866.5765	866.5765 Retinol-binding protein immunological test system.
21:8.0.1.1.20.6.1.61	SECTION 866.5775	866.5775 Rheumatoid factor immunological test system.
21:8.0.1.1.20.6.1.62	SECTION 866.5785	866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
21:8.0.1.1.20.6.1.63	SECTION 866.5800	866.5800 Seminal fluid (sperm) immunological test system.
21:8.0.1.1.20.6.1.64	SECTION 866.5820	866.5820 Systemic lupus erythematosus immunological test system.
21:8.0.1.1.20.6.1.65	SECTION 866.5830	866.5830 Brain trauma assessment test.
21:8.0.1.1.20.6.1.66	SECTION 866.5860	866.5860 Total spinal fluid immunological test system.
21:8.0.1.1.20.6.1.67	SECTION 866.5870	866.5870 Thyroid autoantibody immunological test system.
21:8.0.1.1.20.6.1.68	SECTION 866.5880	866.5880 Transferrin immunological test system.
21:8.0.1.1.20.6.1.69	SECTION 866.5890	866.5890 Inter-alpha trypsin inhibitor immunological test system.
21:8.0.1.1.20.6.1.70	SECTION 866.5900	866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
21:8.0.1.1.20.6.1.71	SECTION 866.5910	866.5910 Quality control material for cystic fibrosis nucleic acid assays.
21:8.0.1.1.20.6.1.72	SECTION 866.5930	866.5930 Newborn screening test for severe combined immunodeficiency disorder (SCID).
21:8.0.1.1.20.6.1.73	SECTION 866.5940	866.5940 Autosomal recessive carrier screening gene mutation detection system.
21:8.0.1.1.20.6.1.74	SECTION 866.5950	866.5950 Genetic health risk assessment system.
21:8.0.1.1.20.7	SUBPART G	Subpart G - Tumor Associated Antigen immunological Test Systems
21:8.0.1.1.20.7.1.1	SECTION 866.6010	866.6010 Tumor-associated antigen immunological test system.
21:8.0.1.1.20.7.1.2	SECTION 866.6020	866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
21:8.0.1.1.20.7.1.3	SECTION 866.6030	866.6030 AFP-L3% immunological test system.
21:8.0.1.1.20.7.1.4	SECTION 866.6040	866.6040 Gene expression profiling test system for breast cancer prognosis.
21:8.0.1.1.20.7.1.5	SECTION 866.6050	866.6050 Ovarian adnexal mass assessment score test system.
21:8.0.1.1.20.7.1.6	SECTION 866.6060	866.6060 BCR-ABL quantitation test.
21:8.0.1.1.20.7.1.7	SECTION 866.6080	866.6080 Next generation sequencing based tumor profiling test.
21:8.0.1.1.21	PART 868	PART 868 - ANESTHESIOLOGY DEVICES
21:8.0.1.1.21.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.21.1.1.1	SECTION 868.1	868.1 Scope.
21:8.0.1.1.21.1.1.2	SECTION 868.3	868.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.21.1.1.3	SECTION 868.9	868.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.21.2	SUBPART B	Subpart B - Diagnostic Devices
21:8.0.1.1.21.2.1.1	SECTION 868.1030	868.1030 Manual algesimeter.
21:8.0.1.1.21.2.1.2	SECTION 868.1040	868.1040 Powered algesimeter.
21:8.0.1.1.21.2.1.3	SECTION 868.1075	868.1075 Argon gas analyzer.
21:8.0.1.1.21.2.1.4	SECTION 868.1100	868.1100 Arterial blood sampling kit.
21:8.0.1.1.21.2.1.5	SECTION 868.1120	868.1120 Indwelling blood oxyhemoglobin concentration analyzer.
21:8.0.1.1.21.2.1.6	SECTION 868.1150	868.1150 Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
21:8.0.1.1.21.2.1.7	SECTION 868.1170	868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.
21:8.0.1.1.21.2.1.8	SECTION 868.1200	868.1200 Indwelling blood oxygen partial pressure (PO2) analyzer.
21:8.0.1.1.21.2.1.9	SECTION 868.1400	868.1400 Carbon dioxide gas analyzer.
21:8.0.1.1.21.2.1.10	SECTION 868.1430	868.1430 Carbon monoxide gas analyzer.
21:8.0.1.1.21.2.1.11	SECTION 868.1500	868.1500 Enflurane gas analyzer.
21:8.0.1.1.21.2.1.12	SECTION 868.1505	868.1505 Ventilatory electrical impedance tomograph.
21:8.0.1.1.21.2.1.13	SECTION 868.1575	868.1575 Gas collection vessel.
21:8.0.1.1.21.2.1.14	SECTION 868.1620	868.1620 Halothane gas analyzer.
21:8.0.1.1.21.2.1.15	SECTION 868.1640	868.1640 Helium gas analyzer.
21:8.0.1.1.21.2.1.16	SECTION 868.1670	868.1670 Neon gas analyzer.
21:8.0.1.1.21.2.1.17	SECTION 868.1690	868.1690 Nitrogen gas analyzer.
21:8.0.1.1.21.2.1.18	SECTION 868.1700	868.1700 Nitrous oxide gas analyzer.
21:8.0.1.1.21.2.1.19	SECTION 868.1720	868.1720 Oxygen gas analyzer.
21:8.0.1.1.21.2.1.20	SECTION 868.1730	868.1730 Oxygen uptake computer.
21:8.0.1.1.21.2.1.21	SECTION 868.1750	868.1750 Pressure plethysmograph.
21:8.0.1.1.21.2.1.22	SECTION 868.1760	868.1760 Volume plethysmograph.
21:8.0.1.1.21.2.1.23	SECTION 868.1780	868.1780 Inspiratory airway pressure meter.
21:8.0.1.1.21.2.1.24	SECTION 868.1800	868.1800 Rhinoanemometer.
21:8.0.1.1.21.2.1.25	SECTION 868.1840	868.1840 Diagnostic spirometer.
21:8.0.1.1.21.2.1.26	SECTION 868.1850	868.1850 Monitoring spirometer.
21:8.0.1.1.21.2.1.27	SECTION 868.1860	868.1860 Peak-flow meter for spirometry.
21:8.0.1.1.21.2.1.28	SECTION 868.1870	868.1870 Gas volume calibrator.
21:8.0.1.1.21.2.1.29	SECTION 868.1880	868.1880 Pulmonary-function data calculator.
21:8.0.1.1.21.2.1.30	SECTION 868.1890	868.1890 Predictive pulmonary-function value calculator.
21:8.0.1.1.21.2.1.31	SECTION 868.1900	868.1900 Diagnostic pulmonary-function interpretation calculator.
21:8.0.1.1.21.2.1.32	SECTION 868.1910	868.1910 Esophageal stethoscope.
21:8.0.1.1.21.2.1.33	SECTION 868.1920	868.1920 Esophageal stethoscope with electrical conductors.
21:8.0.1.1.21.2.1.34	SECTION 868.1930	868.1930 Stethoscope head.
21:8.0.1.1.21.2.1.35	SECTION 868.1965	868.1965 Switching valve (ploss).
21:8.0.1.1.21.2.1.36	SECTION 868.1975	868.1975 Water vapor analyzer.
21:8.0.1.1.21.3	SUBPART C	Subpart C - Monitoring Devices
21:8.0.1.1.21.3.1.1	SECTION 868.2025	868.2025 Ultrasonic air embolism monitor.
21:8.0.1.1.21.3.1.2	SECTION 868.2300	868.2300 Bourdon gauge flowmeter.
21:8.0.1.1.21.3.1.3	SECTION 868.2320	868.2320 Uncompensated thorpe tube flowmeter.
21:8.0.1.1.21.3.1.4	SECTION 868.2340	868.2340 Compensated thorpe tube flowmeter.
21:8.0.1.1.21.3.1.5	SECTION 868.2350	868.2350 Gas calibration flowmeter.
21:8.0.1.1.21.3.1.6	SECTION 868.2375	868.2375 Breathing frequency monitor.
21:8.0.1.1.21.3.1.7	SECTION 868.2377	868.2377 Apnea monitor.
21:8.0.1.1.21.3.1.8	SECTION 868.2380	868.2380 Nitric oxide analyzer.
21:8.0.1.1.21.3.1.9	SECTION 868.2385	868.2385 Nitrogen dioxide analyzer.
21:8.0.1.1.21.3.1.10	SECTION 868.2450	868.2450 Lung water monitor.
21:8.0.1.1.21.3.1.11	SECTION 868.2480	868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
21:8.0.1.1.21.3.1.12	SECTION 868.2500	868.2500 Cutaneous oxygen (PcO2) monitor.
21:8.0.1.1.21.3.1.13	SECTION 868.2550	868.2550 Pneumotachometer.
21:8.0.1.1.21.3.1.14	SECTION 868.2600	868.2600 Airway pressure monitor.
21:8.0.1.1.21.3.1.15	SECTION 868.2610	868.2610 Gas pressure gauge.
21:8.0.1.1.21.3.1.16	SECTION 868.2620	868.2620 Gas pressure calibrator.
21:8.0.1.1.21.3.1.17	SECTION 868.2700	868.2700 Pressure regulator.
21:8.0.1.1.21.3.1.18	SECTION 868.2775	868.2775 Electrical peripheral nerve stimulator.
21:8.0.1.1.21.3.1.19	SECTION 868.2875	868.2875 Differential pressure transducer.
21:8.0.1.1.21.3.1.20	SECTION 868.2885	868.2885 Gas flow transducer.
21:8.0.1.1.21.3.1.21	SECTION 868.2900	868.2900 Gas pressure transducer.
21:8.0.1.1.21.4	SUBPART D	Subparts D-E [Reserved]
21:8.0.1.1.21.5	SUBPART F	Subpart F - Therapeutic Devices
21:8.0.1.1.21.5.1.1	SECTION 868.5090	868.5090 Emergency airway needle.
21:8.0.1.1.21.5.1.2	SECTION 868.5100	868.5100 Nasopharyngeal airway.
21:8.0.1.1.21.5.1.3	SECTION 868.5105	868.5105 External negative pressure airway aid.
21:8.0.1.1.21.5.1.4	SECTION 868.5110	868.5110 Oropharyngeal airway.
21:8.0.1.1.21.5.1.5	SECTION 868.5115	868.5115 Device to relieve acute upper airway obstruction.
21:8.0.1.1.21.5.1.6	SECTION 868.5120	868.5120 Anesthesia conduction catheter.
21:8.0.1.1.21.5.1.7	SECTION 868.5130	868.5130 Anesthesia conduction filter.
21:8.0.1.1.21.5.1.8	SECTION 868.5140	868.5140 Anesthesia conduction kit.
21:8.0.1.1.21.5.1.9	SECTION 868.5150	868.5150 Anesthesia conduction needle.
21:8.0.1.1.21.5.1.10	SECTION 868.5160	868.5160 Gas machine for anesthesia or analgesia.
21:8.0.1.1.21.5.1.11	SECTION 868.5165	868.5165 Nitric oxide administration apparatus.
21:8.0.1.1.21.5.1.12	SECTION 868.5170	868.5170 Laryngotracheal topical anesthesia applicator.
21:8.0.1.1.21.5.1.13	SECTION 868.5180	868.5180 Rocking bed.
21:8.0.1.1.21.5.1.14	SECTION 868.5220	868.5220 Blow bottle.
21:8.0.1.1.21.5.1.15	SECTION 868.5240	868.5240 Anesthesia breathing circuit.
21:8.0.1.1.21.5.1.16	SECTION 868.5250	868.5250 Breathing circuit circulator.
21:8.0.1.1.21.5.1.17	SECTION 868.5260	868.5260 Breathing circuit bacterial filter.
21:8.0.1.1.21.5.1.18	SECTION 868.5270	868.5270 Breathing system heater.
21:8.0.1.1.21.5.1.19	SECTION 868.5273	868.5273 Positive airway pressure delivery system.
21:8.0.1.1.21.5.1.20	SECTION 868.5280	868.5280 Breathing tube support.
21:8.0.1.1.21.5.1.21	SECTION 868.5300	868.5300 Carbon dioxide absorbent.
21:8.0.1.1.21.5.1.22	SECTION 868.5310	868.5310 Carbon dioxide absorber.
21:8.0.1.1.21.5.1.23	SECTION 868.5320	868.5320 Reservoir bag.
21:8.0.1.1.21.5.1.24	SECTION 868.5330	868.5330 Breathing gas mixer.
21:8.0.1.1.21.5.1.25	SECTION 868.5340	868.5340 Nasal oxygen cannula.
21:8.0.1.1.21.5.1.26	SECTION 868.5350	868.5350 Nasal oxygen catheter.
21:8.0.1.1.21.5.1.27	SECTION 868.5365	868.5365 Posture chair for cardiac or pulmonary treatment.
21:8.0.1.1.21.5.1.28	SECTION 868.5375	868.5375 Heat and moisture condenser (artificial nose).
21:8.0.1.1.21.5.1.29	SECTION 868.5400	868.5400 Electroanesthesia apparatus.
21:8.0.1.1.21.5.1.30	SECTION 868.5420	868.5420 Ether hook.
21:8.0.1.1.21.5.1.31	SECTION 868.5430	868.5430 Gas-scavenging apparatus.
21:8.0.1.1.21.5.1.32	SECTION 868.5440	868.5440 Portable oxygen generator.
21:8.0.1.1.21.5.1.33	SECTION 868.5450	868.5450 Respiratory gas humidifier.
21:8.0.1.1.21.5.1.34	SECTION 868.5454	868.5454 High flow humidified oxygen delivery device.
21:8.0.1.1.21.5.1.35	SECTION 868.5460	868.5460 Therapeutic humidifier for home use.
21:8.0.1.1.21.5.1.36	SECTION 868.5470	868.5470 Hyperbaric chamber.
21:8.0.1.1.21.5.1.37	SECTION 868.5530	868.5530 Flexible laryngoscope.
21:8.0.1.1.21.5.1.38	SECTION 868.5540	868.5540 Rigid laryngoscope.
21:8.0.1.1.21.5.1.39	SECTION 868.5550	868.5550 Anesthetic gas mask.
21:8.0.1.1.21.5.1.40	SECTION 868.5560	868.5560 Gas mask head strap.
21:8.0.1.1.21.5.1.41	SECTION 868.5570	868.5570 Nonrebreathing mask.
21:8.0.1.1.21.5.1.42	SECTION 868.5580	868.5580 Oxygen mask.
21:8.0.1.1.21.5.1.43	SECTION 868.5590	868.5590 Scavenging mask.
21:8.0.1.1.21.5.1.44	SECTION 868.5600	868.5600 Venturi mask.
21:8.0.1.1.21.5.1.45	SECTION 868.5620	868.5620 Breathing mouthpiece.
21:8.0.1.1.21.5.1.46	SECTION 868.5630	868.5630 Nebulizer.
21:8.0.1.1.21.5.1.47	SECTION 868.5640	868.5640 Medicinal nonventilatory nebulizer (atomizer).
21:8.0.1.1.21.5.1.48	SECTION 868.5650	868.5650 Esophageal obturator.
21:8.0.1.1.21.5.1.49	SECTION 868.5655	868.5655 Portable liquid oxygen unit.
21:8.0.1.1.21.5.1.50	SECTION 868.5665	868.5665 Powered percussor.
21:8.0.1.1.21.5.1.51	SECTION 868.5675	868.5675 Rebreathing device.
21:8.0.1.1.21.5.1.52	SECTION 868.5690	868.5690 Incentive spirometer.
21:8.0.1.1.21.5.1.53	SECTION 868.5700	868.5700 Nonpowered oxygen tent.
21:8.0.1.1.21.5.1.54	SECTION 868.5710	868.5710 Electrically powered oxygen tent.
21:8.0.1.1.21.5.1.55	SECTION 868.5720	868.5720 Bronchial tube.
21:8.0.1.1.21.5.1.56	SECTION 868.5730	868.5730 Tracheal tube.
21:8.0.1.1.21.5.1.57	SECTION 868.5740	868.5740 Tracheal/bronchial differential ventilation tube.
21:8.0.1.1.21.5.1.58	SECTION 868.5750	868.5750 Inflatable tracheal tube cuff.
21:8.0.1.1.21.5.1.59	SECTION 868.5760	868.5760 Cuff spreader.
21:8.0.1.1.21.5.1.60	SECTION 868.5770	868.5770 Tracheal tube fixation device.
21:8.0.1.1.21.5.1.61	SECTION 868.5780	868.5780 Tube introduction forceps.
21:8.0.1.1.21.5.1.62	SECTION 868.5790	868.5790 Tracheal tube stylet.
21:8.0.1.1.21.5.1.63	SECTION 868.5795	868.5795 Tracheal tube cleaning brush.
21:8.0.1.1.21.5.1.64	SECTION 868.5800	868.5800 Tracheostomy tube and tube cuff.
21:8.0.1.1.21.5.1.65	SECTION 868.5810	868.5810 Airway connector.
21:8.0.1.1.21.5.1.66	SECTION 868.5820	868.5820 Dental protector.
21:8.0.1.1.21.5.1.67	SECTION 868.5830	868.5830 Autotransfusion apparatus.
21:8.0.1.1.21.5.1.68	SECTION 868.5860	868.5860 Pressure tubing and accessories.
21:8.0.1.1.21.5.1.69	SECTION 868.5870	868.5870 Nonrebreathing valve.
21:8.0.1.1.21.5.1.70	SECTION 868.5880	868.5880 Anesthetic vaporizer.
21:8.0.1.1.21.5.1.71	SECTION 868.5895	868.5895 Continuous ventilator.
21:8.0.1.1.21.5.1.72	SECTION 868.5905	868.5905 Noncontinuous ventilator (IPPB).
21:8.0.1.1.21.5.1.73	SECTION 868.5915	868.5915 Manual emergency ventilator.
21:8.0.1.1.21.5.1.74	SECTION 868.5925	868.5925 Powered emergency ventilator.
21:8.0.1.1.21.5.1.75	SECTION 868.5935	868.5935 External negative pressure ventilator.
21:8.0.1.1.21.5.1.76	SECTION 868.5955	868.5955 Intermittent mandatory ventilation attachment.
21:8.0.1.1.21.5.1.77	SECTION 868.5965	868.5965 Positive end expiratory pressure breathing attachment.
21:8.0.1.1.21.5.1.78	SECTION 868.5975	868.5975 Ventilator tubing.
21:8.0.1.1.21.5.1.79	SECTION 868.5995	868.5995 Tee drain (water trap).
21:8.0.1.1.21.6	SUBPART G	Subpart G - Miscellaneous
21:8.0.1.1.21.6.1.1	SECTION 868.6100	868.6100 Anesthetic cabinet, table, or tray.
21:8.0.1.1.21.6.1.2	SECTION 868.6175	868.6175 Cardiopulmonary emergency cart.
21:8.0.1.1.21.6.1.3	SECTION 868.6225	868.6225 Nose clip.
21:8.0.1.1.21.6.1.4	SECTION 868.6250	868.6250 Portable air compressor.
21:8.0.1.1.21.6.1.5	SECTION 868.6400	868.6400 Calibration gas.
21:8.0.1.1.21.6.1.6	SECTION 868.6700	868.6700 Anesthesia stool.
21:8.0.1.1.21.6.1.7	SECTION 868.6810	868.6810 Tracheobronchial suction catheter.
21:8.0.1.1.21.6.1.8	SECTION 868.6820	868.6820 Patient position support.
21:8.0.1.1.21.6.1.9	SECTION 868.6885	868.6885 Medical gas yoke assembly.
21:8.0.1.1.22	PART 870	PART 870 - CARDIOVASCULAR DEVICES
21:8.0.1.1.22.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.22.1.1.1	SECTION 870.1	870.1 Scope.
21:8.0.1.1.22.1.1.2	SECTION 870.3	870.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.22.1.1.3	SECTION 870.9	870.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.22.2	SUBPART B	Subpart B - Cardiovascular Diagnostic Devices
21:8.0.1.1.22.2.1.1	SECTION 870.1025	870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
21:8.0.1.1.22.2.1.2	SECTION 870.1100	870.1100 Blood pressure alarm.
21:8.0.1.1.22.2.1.3	SECTION 870.1110	870.1110 Blood pressure computer.
21:8.0.1.1.22.2.1.4	SECTION 870.1120	870.1120 Blood pressure cuff.
21:8.0.1.1.22.2.1.5	SECTION 870.1130	870.1130 Noninvasive blood pressure measurement system.
21:8.0.1.1.22.2.1.6	SECTION 870.1140	870.1140 Venous blood pressure manometer.
21:8.0.1.1.22.2.1.7	SECTION 870.1200	870.1200 Diagnostic intravascular catheter.
21:8.0.1.1.22.2.1.8	SECTION 870.1210	870.1210 Continuous flush catheter.
21:8.0.1.1.22.2.1.9	SECTION 870.1220	870.1220 Electrode recording catheter or electrode recording probe.
21:8.0.1.1.22.2.1.10	SECTION 870.1230	870.1230 Fiberoptic oximeter catheter.
21:8.0.1.1.22.2.1.11	SECTION 870.1240	870.1240 Flow-directed catheter.
21:8.0.1.1.22.2.1.12	SECTION 870.1250	870.1250 Percutaneous catheter.
21:8.0.1.1.22.2.1.13	SECTION 870.1251	870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.
21:8.0.1.1.22.2.1.14	SECTION 870.1255	870.1255 Balloon aortic valvuloplasty catheter.
21:8.0.1.1.22.2.1.15	SECTION 870.1270	870.1270 Intracavitary phonocatheter system.
21:8.0.1.1.22.2.1.16	SECTION 870.1280	870.1280 Steerable catheter.
21:8.0.1.1.22.2.1.17	SECTION 870.1290	870.1290 Steerable catheter control system.
21:8.0.1.1.22.2.1.18	SECTION 870.1300	870.1300 Catheter cannula.
21:8.0.1.1.22.2.1.19	SECTION 870.1310	870.1310 Vessel dilator for percutaneous catheterization.
21:8.0.1.1.22.2.1.20	SECTION 870.1330	870.1330 Catheter guide wire.
21:8.0.1.1.22.2.1.21	SECTION 870.1340	870.1340 Catheter introducer.
21:8.0.1.1.22.2.1.22	SECTION 870.1350	870.1350 Catheter balloon repair kit.
21:8.0.1.1.22.2.1.23	SECTION 870.1360	870.1360 Trace microsphere.
21:8.0.1.1.22.2.1.24	SECTION 870.1370	870.1370 Catheter tip occluder.
21:8.0.1.1.22.2.1.25	SECTION 870.1380	870.1380 Catheter stylet.
21:8.0.1.1.22.2.1.26	SECTION 870.1390	870.1390 Trocar.
21:8.0.1.1.22.2.1.27	SECTION 870.1415	870.1415 Coronary vascular physiologic simulation software device.
21:8.0.1.1.22.2.1.28	SECTION 870.1425	870.1425 Programmable diagnostic computer.
21:8.0.1.1.22.2.1.29	SECTION 870.1435	870.1435 Single-function, preprogrammed diagnostic computer.
21:8.0.1.1.22.2.1.30	SECTION 870.1450	870.1450 Densitometer.
21:8.0.1.1.22.2.1.31	SECTION 870.1650	870.1650 Angiographic injector and syringe.
21:8.0.1.1.22.2.1.32	SECTION 870.1660	870.1660 Indicator injector.
21:8.0.1.1.22.2.1.33	SECTION 870.1670	870.1670 Syringe actuator for an injector.
21:8.0.1.1.22.2.1.34	SECTION 870.1750	870.1750 External programmable pacemaker pulse generator.
21:8.0.1.1.22.2.1.35	SECTION 870.1800	870.1800 Withdrawal-infusion pump.
21:8.0.1.1.22.2.1.36	SECTION 870.1875	870.1875 Stethoscope.
21:8.0.1.1.22.2.1.37	SECTION 870.1915	870.1915 Thermodilution probe.
21:8.0.1.1.22.3	SUBPART C	Subpart C - Cardiovascular Monitoring Devices
21:8.0.1.1.22.3.1.1	SECTION 870.2050	870.2050 Biopotential amplifier and signal conditioner.
21:8.0.1.1.22.3.1.2	SECTION 870.2060	870.2060 Transducer signal amplifier and conditioner.
21:8.0.1.1.22.3.1.3	SECTION 870.2100	870.2100 Cardiovascular blood flowmeter.
21:8.0.1.1.22.3.1.4	SECTION 870.2120	870.2120 Extravascular blood flow probe.
21:8.0.1.1.22.3.1.5	SECTION 870.2200	870.2200 Adjunctive cardiovascular status indicator.
21:8.0.1.1.22.3.1.6	SECTION 870.2300	870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
21:8.0.1.1.22.3.1.7	SECTION 870.2310	870.2310 Apex cardiograph (vibrocardiograph).
21:8.0.1.1.22.3.1.8	SECTION 870.2320	870.2320 Ballistocardiograph.
21:8.0.1.1.22.3.1.9	SECTION 870.2330	870.2330 Echocardiograph.
21:8.0.1.1.22.3.1.10	SECTION 870.2340	870.2340 Electrocardiograph.
21:8.0.1.1.22.3.1.11	SECTION 870.2350	870.2350 Electrocardiograph lead switching adaptor.
21:8.0.1.1.22.3.1.12	SECTION 870.2360	870.2360 Electrocardiograph electrode.
21:8.0.1.1.22.3.1.13	SECTION 870.2370	870.2370 Electrocardiograph surface electrode tester.
21:8.0.1.1.22.3.1.14	SECTION 870.2390	870.2390 Phonocardiograph.
21:8.0.1.1.22.3.1.15	SECTION 870.2400	870.2400 Vectorcardiograph.
21:8.0.1.1.22.3.1.16	SECTION 870.2450	870.2450 Medical cathode-ray tube display.
21:8.0.1.1.22.3.1.17	SECTION 870.2600	870.2600 Signal isolation system.
21:8.0.1.1.22.3.1.18	SECTION 870.2620	870.2620 Line isolation monitor.
21:8.0.1.1.22.3.1.19	SECTION 870.2640	870.2640 Portable leakage current alarm.
21:8.0.1.1.22.3.1.20	SECTION 870.2675	870.2675 Oscillometer.
21:8.0.1.1.22.3.1.21	SECTION 870.2700	870.2700 Oximeter.
21:8.0.1.1.22.3.1.22	SECTION 870.2710	870.2710 Ear oximeter.
21:8.0.1.1.22.3.1.23	SECTION 870.2750	870.2750 Impedance phlebograph.
21:8.0.1.1.22.3.1.24	SECTION 870.2770	870.2770 Impedance plethysmograph.
21:8.0.1.1.22.3.1.25	SECTION 870.2780	870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
21:8.0.1.1.22.3.1.26	SECTION 870.2800	870.2800 Medical magnetic tape recorder.
21:8.0.1.1.22.3.1.27	SECTION 870.2810	870.2810 Paper chart recorder.
21:8.0.1.1.22.3.1.28	SECTION 870.2840	870.2840 Apex cardiographic transducer.
21:8.0.1.1.22.3.1.29	SECTION 870.2850	870.2850 Extravascular blood pressure transducer.
21:8.0.1.1.22.3.1.30	SECTION 870.2855	870.2855 Implantable Intra-aneurysm Pressure Measurement System.
21:8.0.1.1.22.3.1.31	SECTION 870.2860	870.2860 Heart sound transducer.
21:8.0.1.1.22.3.1.32	SECTION 870.2870	870.2870 Catheter tip pressure transducer.
21:8.0.1.1.22.3.1.33	SECTION 870.2880	870.2880 Ultrasonic transducer.
21:8.0.1.1.22.3.1.34	SECTION 870.2890	870.2890 Vessel occlusion transducer.
21:8.0.1.1.22.3.1.35	SECTION 870.2900	870.2900 Patient transducer and electrode cable (including connector).
21:8.0.1.1.22.3.1.36	SECTION 870.2910	870.2910 Radiofrequency physiological signal transmitter and receiver.
21:8.0.1.1.22.3.1.37	SECTION 870.2920	870.2920 Telephone electrocardiograph transmitter and receiver.
21:8.0.1.1.22.4	SUBPART D	Subpart D - Cardiovascular Prosthetic Devices
21:8.0.1.1.22.4.1.1	SECTION 870.3250	870.3250 Vascular clip.
21:8.0.1.1.22.4.1.2	SECTION 870.3260	870.3260 Vena cava clip.
21:8.0.1.1.22.4.1.3	SECTION 870.3300	870.3300 Vascular embolization device.
21:8.0.1.1.22.4.1.4	SECTION 870.3375	870.3375 Cardiovascular intravascular filter.
21:8.0.1.1.22.4.1.5	SECTION 870.3450	870.3450 Vascular graft prosthesis.
21:8.0.1.1.22.4.1.6	SECTION 870.3460	870.3460 Endovascular Suturing System.
21:8.0.1.1.22.4.1.7	SECTION 870.3470	870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
21:8.0.1.1.22.4.1.8	SECTION 870.3535	870.3535 Intra-aortic balloon and control system.
21:8.0.1.1.22.4.1.9	SECTION 870.3545	870.3545 Ventricular bypass (assist) device.
21:8.0.1.1.22.4.1.10	SECTION 870.3600	870.3600 External pacemaker pulse generator.
21:8.0.1.1.22.4.1.11	SECTION 870.3605	870.3605 Pacing system analyzer.
21:8.0.1.1.22.4.1.12	SECTION 870.3610	870.3610 Implantable pacemaker pulse generator.
21:8.0.1.1.22.4.1.13	SECTION 870.3620	870.3620 Pacemaker lead adaptor.
21:8.0.1.1.22.4.1.14	SECTION 870.3630	870.3630 Pacemaker generator function analyzer.
21:8.0.1.1.22.4.1.15	SECTION 870.3640	870.3640 Indirect pacemaker generator function analyzer.
21:8.0.1.1.22.4.1.16	SECTION 870.3650	870.3650 Pacemaker polymeric mesh bag.
21:8.0.1.1.22.4.1.17	SECTION 870.3670	870.3670 Pacemaker charger.
21:8.0.1.1.22.4.1.18	SECTION 870.3680	870.3680 Cardiovascular permanent or temporary pacemaker electrode.
21:8.0.1.1.22.4.1.19	SECTION 870.3690	870.3690 Pacemaker test magnet.
21:8.0.1.1.22.4.1.20	SECTION 870.3700	870.3700 Pacemaker programmers.
21:8.0.1.1.22.4.1.21	SECTION 870.3710	870.3710 Pacemaker repair or replacement material.
21:8.0.1.1.22.4.1.22	SECTION 870.3720	870.3720 Pacemaker electrode function tester.
21:8.0.1.1.22.4.1.23	SECTION 870.3730	870.3730 Pacemaker service tools.
21:8.0.1.1.22.4.1.24	SECTION 870.3800	870.3800 Annuloplasty ring.
21:8.0.1.1.22.4.1.25	SECTION 870.3850	870.3850 Carotid sinus nerve stimulator.
21:8.0.1.1.22.4.1.26	SECTION 870.3925	870.3925 Replacement heart valve.
21:8.0.1.1.22.4.1.27	SECTION 870.3935	870.3935 Prosthetic heart valve holder.
21:8.0.1.1.22.4.1.28	SECTION 870.3945	870.3945 Prosthetic heart valve sizer.
21:8.0.1.1.22.5	SUBPART E	Subpart E - Cardiovascular Surgical Devices
21:8.0.1.1.22.5.1.1	SECTION 870.4075	870.4075 Endomyocardial biopsy device.
21:8.0.1.1.22.5.1.2	SECTION 870.4100	870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
21:8.0.1.1.22.5.1.3	SECTION 870.4200	870.4200 Cardiopulmonary bypass accessory equipment.
21:8.0.1.1.22.5.1.4	SECTION 870.4205	870.4205 Cardiopulmonary bypass bubble detector.
21:8.0.1.1.22.5.1.5	SECTION 870.4210	870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
21:8.0.1.1.22.5.1.6	SECTION 870.4220	870.4220 Cardiopulmonary bypass heart-lung machine console.
21:8.0.1.1.22.5.1.7	SECTION 870.4230	870.4230 Cardiopulmonary bypass defoamer.
21:8.0.1.1.22.5.1.8	SECTION 870.4240	870.4240 Cardiopulmonary bypass heat exchanger.
21:8.0.1.1.22.5.1.9	SECTION 870.4250	870.4250 Cardiopulmonary bypass temperature controller.
21:8.0.1.1.22.5.1.10	SECTION 870.4260	870.4260 Cardiopulmonary bypass arterial line blood filter.
21:8.0.1.1.22.5.1.11	SECTION 870.4270	870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
21:8.0.1.1.22.5.1.12	SECTION 870.4280	870.4280 Cardiopulmonary prebypass filter.
21:8.0.1.1.22.5.1.13	SECTION 870.4290	870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
21:8.0.1.1.22.5.1.14	SECTION 870.4300	870.4300 Cardiopulmonary bypass gas control unit.
21:8.0.1.1.22.5.1.15	SECTION 870.4310	870.4310 Cardiopulmonary bypass coronary pressure gauge.
21:8.0.1.1.22.5.1.16	SECTION 870.4320	870.4320 Cardiopulmonary bypass pulsatile flow generator.
21:8.0.1.1.22.5.1.17	SECTION 870.4330	870.4330 Cardiopulmonary bypass on-line blood gas monitor.
21:8.0.1.1.22.5.1.18	SECTION 870.4340	870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
21:8.0.1.1.22.5.1.19	SECTION 870.4350	870.4350 Cardiopulmonary bypass oxygenator.
21:8.0.1.1.22.5.1.20	SECTION 870.4360	870.4360 Nonroller-type blood pump.
21:8.0.1.1.22.5.1.21	SECTION 870.4370	870.4370 Roller-type cardiopulmonary bypass blood pump.
21:8.0.1.1.22.5.1.22	SECTION 870.4380	870.4380 Cardiopulmonary bypass pump speed control.
21:8.0.1.1.22.5.1.23	SECTION 870.4390	870.4390 Cardiopulmonary bypass pump tubing.
21:8.0.1.1.22.5.1.24	SECTION 870.4400	870.4400 Cardiopulmonary bypass blood reservoir.
21:8.0.1.1.22.5.1.25	SECTION 870.4410	870.4410 Cardiopulmonary bypass in-line blood gas sensor.
21:8.0.1.1.22.5.1.26	SECTION 870.4420	870.4420 Cardiopulmonary bypass cardiotomy return sucker.
21:8.0.1.1.22.5.1.27	SECTION 870.4430	870.4430 Cardiopulmonary bypass intracardiac suction control.
21:8.0.1.1.22.5.1.28	SECTION 870.4450	870.4450 Vascular clamp.
21:8.0.1.1.22.5.1.29	SECTION 870.4475	870.4475 Surgical vessel dilator.
21:8.0.1.1.22.5.1.30	SECTION 870.4500	870.4500 Cardiovascular surgical instruments.
21:8.0.1.1.22.5.1.31	SECTION 870.4510	870.4510 Apical closure device.
21:8.0.1.1.22.5.1.32	SECTION 870.4875	870.4875 Intraluminal artery stripper.
21:8.0.1.1.22.5.1.33	SECTION 870.4885	870.4885 External vein stripper.
21:8.0.1.1.22.6	SUBPART F	Subpart F - Cardiovascular Therapeutic Devices
21:8.0.1.1.22.6.1.1	SECTION 870.5050	870.5050 Patient care suction apparatus.
21:8.0.1.1.22.6.1.2	SECTION 870.5100	870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
21:8.0.1.1.22.6.1.3	SECTION 870.5150	870.5150 Embolectomy catheter.
21:8.0.1.1.22.6.1.4	SECTION 870.5175	870.5175 Septostomy catheter.
21:8.0.1.1.22.6.1.5	SECTION 870.5200	870.5200 External cardiac compressor.
21:8.0.1.1.22.6.1.6	SECTION 870.5210	870.5210 Cardiopulmonary resuscitation (CPR) aid.
21:8.0.1.1.22.6.1.7	SECTION 870.5225	870.5225 External counter-pulsating device.
21:8.0.1.1.22.6.1.8	SECTION 870.5300	870.5300 DC-defibrillator (including paddles).
21:8.0.1.1.22.6.1.9	SECTION 870.5310	870.5310 Automated external defibrillator system.
21:8.0.1.1.22.6.1.10	SECTION 870.5325	870.5325 Defibrillator tester.
21:8.0.1.1.22.6.1.11	SECTION 870.5550	870.5550 External transcutaneous cardiac pacemaker (noninvasive).
21:8.0.1.1.22.6.1.12	SECTION 870.5700	870.5700 Steerable cardiac ablation catheter remote control system.
21:8.0.1.1.22.6.1.13	SECTION 870.5800	870.5800 Compressible limb sleeve.
21:8.0.1.1.22.6.1.14	SECTION 870.5900	870.5900 Thermal regulating system.
21:8.0.1.1.22.6.1.15	SECTION 870.5910	870.5910 Esophageal thermal regulation device.
21:8.0.1.1.22.6.1.16	SECTION 870.5925	870.5925 Automatic rotating tourniquet.
21:8.0.1.1.23	PART 872	PART 872 - DENTAL DEVICES
21:8.0.1.1.23.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.23.1.1.1	SECTION 872.1	872.1 Scope.
21:8.0.1.1.23.1.1.2	SECTION 872.3	872.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.23.1.1.3	SECTION 872.9	872.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.23.2	SUBPART B	Subpart B - Diagnostic Devices
21:8.0.1.1.23.2.1.1	SECTION 872.1500	872.1500 Gingival fluid measurer.
21:8.0.1.1.23.2.1.2	SECTION 872.1720	872.1720 Pulp tester.
21:8.0.1.1.23.2.1.3	SECTION 872.1730	872.1730 Electrode gel for pulp testers.
21:8.0.1.1.23.2.1.4	SECTION 872.1740	872.1740 Caries detection device.
21:8.0.1.1.23.2.1.5	SECTION 872.1745	872.1745 Laser fluorescence caries detection device.
21:8.0.1.1.23.2.1.6	SECTION 872.1800	872.1800 Extraoral source x-ray system.
21:8.0.1.1.23.2.1.7	SECTION 872.1810	872.1810 Intraoral source x-ray system.
21:8.0.1.1.23.2.1.8	SECTION 872.1820	872.1820 Dental x-ray exposure alignment device.
21:8.0.1.1.23.2.1.9	SECTION 872.1830	872.1830 Cephalometer.
21:8.0.1.1.23.2.1.10	SECTION 872.1840	872.1840 Dental x-ray position indicating device.
21:8.0.1.1.23.2.1.11	SECTION 872.1850	872.1850 Lead-lined position indicator.
21:8.0.1.1.23.2.1.12	SECTION 872.1870	872.1870 Sulfide detection device.
21:8.0.1.1.23.2.1.13	SECTION 872.1905	872.1905 Dental x-ray film holder.
21:8.0.1.1.23.2.1.14	SECTION 872.2050	872.2050 Dental sonography device.
21:8.0.1.1.23.2.1.15	SECTION 872.2060	872.2060 Jaw tracking device.
21:8.0.1.1.23.3	SUBPART C	Subpart C [Reserved]
21:8.0.1.1.23.4	SUBPART D	Subpart D - Prosthetic Devices
21:8.0.1.1.23.4.1.1	SECTION 872.3060	872.3060 Noble metal alloy.
21:8.0.1.1.23.4.1.2	SECTION 872.3070	872.3070 Dental amalgam, mercury, and amalgam alloy.
21:8.0.1.1.23.4.1.3	SECTION 872.3080	872.3080 Mercury and alloy dispenser.
21:8.0.1.1.23.4.1.4	SECTION 872.3100	872.3100 Dental amalgamator.
21:8.0.1.1.23.4.1.5	SECTION 872.3110	872.3110 Dental amalgam capsule.
21:8.0.1.1.23.4.1.6	SECTION 872.3130	872.3130 Preformed anchor.
21:8.0.1.1.23.4.1.7	SECTION 872.3140	872.3140 Resin applicator.
21:8.0.1.1.23.4.1.8	SECTION 872.3150	872.3150 Articulator.
21:8.0.1.1.23.4.1.9	SECTION 872.3165	872.3165 Precision attachment.
21:8.0.1.1.23.4.1.10	SECTION 872.3200	872.3200 Resin tooth bonding agent.
21:8.0.1.1.23.4.1.11	SECTION 872.3220	872.3220 Facebow.
21:8.0.1.1.23.4.1.12	SECTION 872.3240	872.3240 Dental bur.
21:8.0.1.1.23.4.1.13	SECTION 872.3250	872.3250 Calcium hydroxide cavity liner.
21:8.0.1.1.23.4.1.14	SECTION 872.3260	872.3260 Cavity varnish.
21:8.0.1.1.23.4.1.15	SECTION 872.3275	872.3275 Dental cement.
21:8.0.1.1.23.4.1.16	SECTION 872.3285	872.3285 Preformed clasp.
21:8.0.1.1.23.4.1.17	SECTION 872.3300	872.3300 Hydrophilic resin coating for dentures.
21:8.0.1.1.23.4.1.18	SECTION 872.3310	872.3310 Coating material for resin fillings.
21:8.0.1.1.23.4.1.19	SECTION 872.3330	872.3330 Preformed crown.
21:8.0.1.1.23.4.1.20	SECTION 872.3350	872.3350 Gold or stainless steel cusp.
21:8.0.1.1.23.4.1.21	SECTION 872.3360	872.3360 Preformed cusp.
21:8.0.1.1.23.4.1.22	SECTION 872.3400	872.3400 Karaya and sodium borate with or without acacia denture adhesive.
21:8.0.1.1.23.4.1.23	SECTION 872.3410	872.3410 Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.
21:8.0.1.1.23.4.1.24	SECTION 872.3420	872.3420 Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive.
21:8.0.1.1.23.4.1.25	SECTION 872.3450	872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive.
21:8.0.1.1.23.4.1.26	SECTION 872.3480	872.3480 Polyacrylamide polymer (modified cationic) denture adhesive.
21:8.0.1.1.23.4.1.27	SECTION 872.3490	872.3490 Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
21:8.0.1.1.23.4.1.28	SECTION 872.3500	872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.
21:8.0.1.1.23.4.1.29	SECTION 872.3520	872.3520 OTC denture cleanser.
21:8.0.1.1.23.4.1.30	SECTION 872.3530	872.3530 Mechanical denture cleaner.
21:8.0.1.1.23.4.1.31	SECTION 872.3540	872.3540 OTC denture cushion or pad.
21:8.0.1.1.23.4.1.32	SECTION 872.3560	872.3560 OTC denture reliner.
21:8.0.1.1.23.4.1.33	SECTION 872.3570	872.3570 OTC denture repair kit.
21:8.0.1.1.23.4.1.34	SECTION 872.3580	872.3580 Preformed gold denture tooth.
21:8.0.1.1.23.4.1.35	SECTION 872.3590	872.3590 Preformed plastic denture tooth.
21:8.0.1.1.23.4.1.36	SECTION 872.3600	872.3600 Partially fabricated denture kit.
21:8.0.1.1.23.4.1.37	SECTION 872.3630	872.3630 Endosseous dental implant abutment.
21:8.0.1.1.23.4.1.38	SECTION 872.3640	872.3640 Endosseous dental implant.
21:8.0.1.1.23.4.1.39	SECTION 872.3645	872.3645 Subperiosteal implant material.
21:8.0.1.1.23.4.1.40	SECTION 872.3660	872.3660 Impression material.
21:8.0.1.1.23.4.1.41	SECTION 872.3661	872.3661 Optical Impression Systems for CAD/CAM.
21:8.0.1.1.23.4.1.42	SECTION 872.3670	872.3670 Resin impression tray material.
21:8.0.1.1.23.4.1.43	SECTION 872.3680	872.3680 Polytetrafluoroethylene (PTFE) vitreous carbon materials.
21:8.0.1.1.23.4.1.44	SECTION 872.3690	872.3690 Tooth shade resin material.
21:8.0.1.1.23.4.1.45	SECTION 872.3710	872.3710 Base metal alloy.
21:8.0.1.1.23.4.1.46	SECTION 872.3730	872.3730 Pantograph.
21:8.0.1.1.23.4.1.47	SECTION 872.3740	872.3740 Retentive and splinting pin.
21:8.0.1.1.23.4.1.48	SECTION 872.3750	872.3750 Bracket adhesive resin and tooth conditioner.
21:8.0.1.1.23.4.1.49	SECTION 872.3760	872.3760 Denture relining, repairing, or rebasing resin.
21:8.0.1.1.23.4.1.50	SECTION 872.3765	872.3765 Pit and fissure sealant and conditioner.
21:8.0.1.1.23.4.1.51	SECTION 872.3770	872.3770 Temporary crown and bridge resin.
21:8.0.1.1.23.4.1.52	SECTION 872.3810	872.3810 Root canal post.
21:8.0.1.1.23.4.1.53	SECTION 872.3820	872.3820 Root canal filling resin.
21:8.0.1.1.23.4.1.54	SECTION 872.3830	872.3830 Endodontic paper point.
21:8.0.1.1.23.4.1.55	SECTION 872.3840	872.3840 Endodontic silver point.
21:8.0.1.1.23.4.1.56	SECTION 872.3850	872.3850 Gutta percha.
21:8.0.1.1.23.4.1.57	SECTION 872.3890	872.3890 Endodontic stabilizing splint.
21:8.0.1.1.23.4.1.58	SECTION 872.3900	872.3900 Posterior artificial tooth with a metal insert.
21:8.0.1.1.23.4.1.59	SECTION 872.3910	872.3910 Backing and facing for an artificial tooth.
21:8.0.1.1.23.4.1.60	SECTION 872.3920	872.3920 Porcelain tooth.
21:8.0.1.1.23.4.1.61	SECTION 872.3930	872.3930 Bone grafting material.
21:8.0.1.1.23.4.1.62	SECTION 872.3940	872.3940 Total temporomandibular joint prosthesis.
21:8.0.1.1.23.4.1.63	SECTION 872.3950	872.3950 Glenoid fossa prosthesis.
21:8.0.1.1.23.4.1.64	SECTION 872.3960	872.3960 Mandibular condyle prosthesis.
21:8.0.1.1.23.4.1.65	SECTION 872.3970	872.3970 Interarticular disc prosthesis (interpositional implant).
21:8.0.1.1.23.4.1.66	SECTION 872.3980	872.3980 Endosseous dental implant accessories.
21:8.0.1.1.23.5	SUBPART E	Subpart E - Surgical Devices
21:8.0.1.1.23.5.1.1	SECTION 872.4120	872.4120 Bone cutting instrument and accessories.
21:8.0.1.1.23.5.1.2	SECTION 872.4130	872.4130 Intraoral dental drill.
21:8.0.1.1.23.5.1.3	SECTION 872.4200	872.4200 Dental handpiece and accessories.
21:8.0.1.1.23.5.1.4	SECTION 872.4465	872.4465 Gas-powered jet injector.
21:8.0.1.1.23.5.1.5	SECTION 872.4475	872.4475 Spring-powered jet injector.
21:8.0.1.1.23.5.1.6	SECTION 872.4535	872.4535 Dental diamond instrument.
21:8.0.1.1.23.5.1.7	SECTION 872.4565	872.4565 Dental hand instrument.
21:8.0.1.1.23.5.1.8	SECTION 872.4600	872.4600 Intraoral ligature and wire lock.
21:8.0.1.1.23.5.1.9	SECTION 872.4620	872.4620 Fiber optic dental light.
21:8.0.1.1.23.5.1.10	SECTION 872.4630	872.4630 Dental operating light.
21:8.0.1.1.23.5.1.11	SECTION 872.4730	872.4730 Dental injecting needle.
21:8.0.1.1.23.5.1.12	SECTION 872.4760	872.4760 Bone plate.
21:8.0.1.1.23.5.1.13	SECTION 872.4770	872.4770 Temporary mandibular condyle reconstruction plate.
21:8.0.1.1.23.5.1.14	SECTION 872.4840	872.4840 Rotary scaler.
21:8.0.1.1.23.5.1.15	SECTION 872.4850	872.4850 Ultrasonic scaler.
21:8.0.1.1.23.5.1.16	SECTION 872.4880	872.4880 Intraosseous fixation screw or wire.
21:8.0.1.1.23.5.1.17	SECTION 872.4920	872.4920 Dental electrosurgical unit and accessories.
21:8.0.1.1.23.6	SUBPART F	Subpart F - Therapeutic Devices
21:8.0.1.1.23.6.1.1	SECTION 872.5410	872.5410 Orthodontic appliance and accessories.
21:8.0.1.1.23.6.1.2	SECTION 872.5470	872.5470 Orthodontic plastic bracket.
21:8.0.1.1.23.6.1.3	SECTION 872.5500	872.5500 Extraoral orthodontic headgear.
21:8.0.1.1.23.6.1.4	SECTION 872.5525	872.5525 Preformed tooth positioner.
21:8.0.1.1.23.6.1.5	SECTION 872.5550	872.5550 Teething ring.
21:8.0.1.1.23.6.1.6	SECTION 872.5560	872.5560 Electrical salivary stimulatory system.
21:8.0.1.1.23.6.1.7	SECTION 872.5570	872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
21:8.0.1.1.23.6.1.8	SECTION 872.5571	872.5571 Auto titration device for oral appliances.
21:8.0.1.1.23.6.1.9	SECTION 872.5580	872.5580 Oral rinse to reduce the adhesion of dental plaque.
21:8.0.1.1.23.7	SUBPART G	Subpart G - Miscellaneous Devices
21:8.0.1.1.23.7.1.1	SECTION 872.6010	872.6010 Abrasive device and accessories.
21:8.0.1.1.23.7.1.2	SECTION 872.6030	872.6030 Oral cavity abrasive polishing agent.
21:8.0.1.1.23.7.1.3	SECTION 872.6050	872.6050 Saliva absorber.
21:8.0.1.1.23.7.1.4	SECTION 872.6070	872.6070 Ultraviolet activator for polymerization.
21:8.0.1.1.23.7.1.5	SECTION 872.6080	872.6080 Airbrush.
21:8.0.1.1.23.7.1.6	SECTION 872.6100	872.6100 Anesthetic warmer.
21:8.0.1.1.23.7.1.7	SECTION 872.6140	872.6140 Articulation paper.
21:8.0.1.1.23.7.1.8	SECTION 872.6200	872.6200 Base plate shellac.
21:8.0.1.1.23.7.1.9	SECTION 872.6250	872.6250 Dental chair and accessories.
21:8.0.1.1.23.7.1.10	SECTION 872.6290	872.6290 Prophylaxis cup.
21:8.0.1.1.23.7.1.11	SECTION 872.6300	872.6300 Rubber dam and accessories.
21:8.0.1.1.23.7.1.12	SECTION 872.6350	872.6350 Ultraviolet detector.
21:8.0.1.1.23.7.1.13	SECTION 872.6390	872.6390 Dental floss.
21:8.0.1.1.23.7.1.14	SECTION 872.6475	872.6475 Heat source for bleaching teeth.
21:8.0.1.1.23.7.1.15	SECTION 872.6510	872.6510 Oral irrigation unit.
21:8.0.1.1.23.7.1.16	SECTION 872.6570	872.6570 Impression tube.
21:8.0.1.1.23.7.1.17	SECTION 872.6640	872.6640 Dental operative unit and accessories.
21:8.0.1.1.23.7.1.18	SECTION 872.6650	872.6650 Massaging pick or tip for oral hygiene.
21:8.0.1.1.23.7.1.19	SECTION 872.6660	872.6660 Porcelain powder for clinical use.
21:8.0.1.1.23.7.1.20	SECTION 872.6670	872.6670 Silicate protector.
21:8.0.1.1.23.7.1.21	SECTION 872.6710	872.6710 Boiling water sterilizer.
21:8.0.1.1.23.7.1.22	SECTION 872.6730	872.6730 Endodontic dry heat sterilizer.
21:8.0.1.1.23.7.1.23	SECTION 872.6770	872.6770 Cartridge syringe.
21:8.0.1.1.23.7.1.24	SECTION 872.6855	872.6855 Manual toothbrush.
21:8.0.1.1.23.7.1.25	SECTION 872.6865	872.6865 Powered toothbrush.
21:8.0.1.1.23.7.1.26	SECTION 872.6870	872.6870 Disposable fluoride tray.
21:8.0.1.1.23.7.1.27	SECTION 872.6880	872.6880 Preformed impression tray.
21:8.0.1.1.23.7.1.28	SECTION 872.6890	872.6890 Intraoral dental wax.
21:8.0.1.1.24	PART 874	PART 874 - EAR, NOSE, AND THROAT DEVICES
21:8.0.1.1.24.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.24.1.1.1	SECTION 874.1	874.1 Scope.
21:8.0.1.1.24.1.1.2	SECTION 874.3	874.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.24.1.1.3	SECTION 874.9	874.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.24.2	SUBPART B	Subpart B - Diagnostic Devices
21:8.0.1.1.24.2.1.1	SECTION 874.1050	874.1050 Audiometer.
21:8.0.1.1.24.2.1.2	SECTION 874.1060	874.1060 Acoustic chamber for audiometric testing.
21:8.0.1.1.24.2.1.3	SECTION 874.1070	874.1070 Short increment sensitivity index (SISI) adapter.
21:8.0.1.1.24.2.1.4	SECTION 874.1080	874.1080 Audiometer calibration set.
21:8.0.1.1.24.2.1.5	SECTION 874.1090	874.1090 Auditory impedance tester.
21:8.0.1.1.24.2.1.6	SECTION 874.1100	874.1100 Earphone cushion for audiometric testing.
21:8.0.1.1.24.2.1.7	SECTION 874.1120	874.1120 Electronic noise generator for audiometric testing.
21:8.0.1.1.24.2.1.8	SECTION 874.1325	874.1325 Electroglottograph.
21:8.0.1.1.24.2.1.9	SECTION 874.1500	874.1500 Gustometer.
21:8.0.1.1.24.2.1.10	SECTION 874.1600	874.1600 Olfactory test device.
21:8.0.1.1.24.2.1.11	SECTION 874.1800	874.1800 Air or water caloric stimulator.
21:8.0.1.1.24.2.1.12	SECTION 874.1820	874.1820 Surgical nerve stimulator/locator.
21:8.0.1.1.24.2.1.13	SECTION 874.1925	874.1925 Toynbee diagnostic tube.
21:8.0.1.1.24.3	SUBPART C	Subpart C [Reserved]
21:8.0.1.1.24.4	SUBPART D	Subpart D - Prosthetic Devices
21:8.0.1.1.24.4.1.1	SECTION 874.3300	874.3300 Hearing Aid.
21:8.0.1.1.24.4.1.2	SECTION 874.3305	874.3305 Wireless air-conduction hearing aid.
21:8.0.1.1.24.4.1.3	SECTION 874.3310	874.3310 Hearing aid calibrator and analysis system.
21:8.0.1.1.24.4.1.4	SECTION 874.3315	874.3315 Tympanic membrane contact hearing aid.
21:8.0.1.1.24.4.1.5	SECTION 874.3320	874.3320 Group hearing aid or group auditory trainer.
21:8.0.1.1.24.4.1.6	SECTION 874.3325	874.3325 Self-fitting air-conduction hearing aid.
21:8.0.1.1.24.4.1.7	SECTION 874.3330	874.3330 Master hearing aid.
21:8.0.1.1.24.4.1.8	SECTION 874.3340	874.3340 Active implantable bone conduction hearing system.
21:8.0.1.1.24.4.1.9	SECTION 874.3375	874.3375 Battery-powered artificial larynx.
21:8.0.1.1.24.4.1.10	SECTION 874.3400	874.3400 Tinnitus masker.
21:8.0.1.1.24.4.1.11	SECTION 874.3430	874.3430 Middle ear mold.
21:8.0.1.1.24.4.1.12	SECTION 874.3450	874.3450 Partial ossicular replacement prosthesis.
21:8.0.1.1.24.4.1.13	SECTION 874.3495	874.3495 Total ossicular replacement prosthesis.
21:8.0.1.1.24.4.1.14	SECTION 874.3540	874.3540 Prosthesis modification instrument for ossicular replacement surgery.
21:8.0.1.1.24.4.1.15	SECTION 874.3620	874.3620 Ear, nose, and throat synthetic polymer material.
21:8.0.1.1.24.4.1.16	SECTION 874.3695	874.3695 Mandibular implant facial prosthesis.
21:8.0.1.1.24.4.1.17	SECTION 874.3730	874.3730 Laryngeal prosthesis (Taub design).
21:8.0.1.1.24.4.1.18	SECTION 874.3760	874.3760 Sacculotomy tack (Cody tack)
21:8.0.1.1.24.4.1.19	SECTION 874.3820	874.3820 Endolymphatic shunt.
21:8.0.1.1.24.4.1.20	SECTION 874.3850	874.3850 Endolymphatic shunt tube with valve.
21:8.0.1.1.24.4.1.21	SECTION 874.3880	874.3880 Tympanostomy tube.
21:8.0.1.1.24.4.1.22	SECTION 874.3900	874.3900 Nasal dilator.
21:8.0.1.1.24.4.1.23	SECTION 874.3930	874.3930 Tympanostomy tube with semipermeable membrane.
21:8.0.1.1.24.4.1.24	SECTION 874.3950	874.3950 Transcutaneous air conduction hearing aid system.
21:8.0.1.1.24.5	SUBPART E	Subpart E - Surgical Devices
21:8.0.1.1.24.5.1.1	SECTION 874.4100	874.4100 Epistaxis balloon.
21:8.0.1.1.24.5.1.2	SECTION 874.4140	874.4140 Ear, nose, and throat bur.
21:8.0.1.1.24.5.1.3	SECTION 874.4175	874.4175 Nasopharyngeal catheter.
21:8.0.1.1.24.5.1.4	SECTION 874.4180	874.4180 Eustachian tube balloon dilation system.
21:8.0.1.1.24.5.1.5	SECTION 874.4250	874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
21:8.0.1.1.24.5.1.6	SECTION 874.4350	874.4350 Ear, nose, and throat fiberoptic light source and carrier.
21:8.0.1.1.24.5.1.7	SECTION 874.4420	874.4420 Ear, nose, and throat manual surgical instrument.
21:8.0.1.1.24.5.1.8	SECTION 874.4490	874.4490 Argon laser for otology, rhinology, and laryngology.
21:8.0.1.1.24.5.1.9	SECTION 874.4500	874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.
21:8.0.1.1.24.5.1.10	SECTION 874.4680	874.4680 Bronchoscope (flexible or rigid) and accessories.
21:8.0.1.1.24.5.1.11	SECTION 874.4710	874.4710 Esophagoscope (flexible or rigid) and accessories.
21:8.0.1.1.24.5.1.12	SECTION 874.4720	874.4720 Mediastinoscope and accessories.
21:8.0.1.1.24.5.1.13	SECTION 874.4750	874.4750 Laryngostroboscope.
21:8.0.1.1.24.5.1.14	SECTION 874.4760	874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
21:8.0.1.1.24.5.1.15	SECTION 874.4770	874.4770 Otoscope.
21:8.0.1.1.24.5.1.16	SECTION 874.4780	874.4780 Intranasal splint.
21:8.0.1.1.24.5.1.17	SECTION 874.4800	874.4800 Bone particle collector.
21:8.0.1.1.24.6	SUBPART F	Subpart F - Therapeutic Devices
21:8.0.1.1.24.6.1.1	SECTION 874.5220	874.5220 Ear, nose, and throat drug administration device.
21:8.0.1.1.24.6.1.2	SECTION 874.5300	874.5300 Ear, nose, and throat examination and treatment unit.
21:8.0.1.1.24.6.1.3	SECTION 874.5350	874.5350 Suction antichoke device.
21:8.0.1.1.24.6.1.4	SECTION 874.5370	874.5370 Tongs antichoke device.
21:8.0.1.1.24.6.1.5	SECTION 874.5550	874.5550 Powered nasal irrigator.
21:8.0.1.1.24.6.1.6	SECTION 874.5800	874.5800 External nasal splint.
21:8.0.1.1.24.6.1.7	SECTION 874.5840	874.5840 Antistammering device.
21:8.0.1.1.24.6.1.8	SECTION 874.5900	874.5900 External upper esophageal sphincter compression device.
21:8.0.1.1.25	PART 876	PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES
21:8.0.1.1.25.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.25.1.1.1	SECTION 876.1	876.1 Scope.
21:8.0.1.1.25.1.1.2	SECTION 876.3	876.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.25.1.1.3	SECTION 876.9	876.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.25.2	SUBPART B	Subpart B - Diagnostic Devices
21:8.0.1.1.25.2.1.1	SECTION 876.1075	876.1075 Gastroenterology-urology biopsy instrument.
21:8.0.1.1.25.2.1.2	SECTION 876.1080	876.1080 Gastroenterology-urology accessories to a biopsy instrument.
21:8.0.1.1.25.2.1.3	SECTION 876.1300	876.1300 Ingestible telemetric gastrointestinal capsule imaging system.
21:8.0.1.1.25.2.1.4	SECTION 876.1330	876.1330 Colon capsule endoscopy system.
21:8.0.1.1.25.2.1.5	SECTION 876.1400	876.1400 Stomach pH electrode.
21:8.0.1.1.25.2.1.6	SECTION 876.1500	876.1500 Endoscope and accessories.
21:8.0.1.1.25.2.1.7	SECTION 876.1620	876.1620 Urodynamics measurement system.
21:8.0.1.1.25.2.1.8	SECTION 876.1725	876.1725 Gastrointestinal motility monitoring system.
21:8.0.1.1.25.2.1.9	SECTION 876.1735	876.1735 Electrogastrography system.
21:8.0.1.1.25.2.1.10	SECTION 876.1800	876.1800 Urine flow or volume measuring system.
21:8.0.1.1.25.3	SUBPART C	Subpart C - Monitoring Devices
21:8.0.1.1.25.3.1.1	SECTION 876.2040	876.2040 Enuresis alarm.
21:8.0.1.1.25.3.1.2	SECTION 876.2050	876.2050 Prostate lesion documentation system.
21:8.0.1.1.25.4	SUBPART D	Subpart D - Prosthetic Devices
21:8.0.1.1.25.4.1.1	SECTION 876.3350	876.3350 Penile inflatable implant.
21:8.0.1.1.25.4.1.2	SECTION 876.3500	876.3500 Penile implant surgical accessories.
21:8.0.1.1.25.4.1.3	SECTION 876.3630	876.3630 Penile rigidity implant.
21:8.0.1.1.25.4.1.4	SECTION 876.3750	876.3750 Testicular prosthesis.
21:8.0.1.1.25.5	SUBPART E	Subpart E - Surgical Devices
21:8.0.1.1.25.5.1.1	SECTION 876.4020	876.4020 Fiberoptic light ureteral catheter.
21:8.0.1.1.25.5.1.2	SECTION 876.4270	876.4270 Colostomy rod.
21:8.0.1.1.25.5.1.3	SECTION 876.4300	876.4300 Endoscopic electrosurgical unit and accessories.
21:8.0.1.1.25.5.1.4	SECTION 876.4310	876.4310 Endoscopic electrosurgical clip cutting system.
21:8.0.1.1.25.5.1.5	SECTION 876.4340	876.4340 High intensity ultrasound system for prostate tissue ablation.
21:8.0.1.1.25.5.1.6	SECTION 876.4350	876.4350 Fluid jet system for prostate tissue removal.
21:8.0.1.1.25.5.1.7	SECTION 876.4370	876.4370 Gastroenterology-urology evacuator.
21:8.0.1.1.25.5.1.8	SECTION 876.4400	876.4400 Hemorrhoidal ligator.
21:8.0.1.1.25.5.1.9	SECTION 876.4480	876.4480 Electrohydraulic lithotriptor.
21:8.0.1.1.25.5.1.10	SECTION 876.4500	876.4500 Mechanical lithotriptor.
21:8.0.1.1.25.5.1.11	SECTION 876.4530	876.4530 Gastroenterology-urology fiberoptic retractor.
21:8.0.1.1.25.5.1.12	SECTION 876.4560	876.4560 Ribdam.
21:8.0.1.1.25.5.1.13	SECTION 876.4590	876.4590 Interlocking urethral sound.
21:8.0.1.1.25.5.1.14	SECTION 876.4620	876.4620 Ureteral stent.
21:8.0.1.1.25.5.1.15	SECTION 876.4630	876.4630 Ureteral stent accessories.
21:8.0.1.1.25.5.1.16	SECTION 876.4650	876.4650 Water jet renal stone dislodger system.
21:8.0.1.1.25.5.1.17	SECTION 876.4680	876.4680 Ureteral stone dislodger.
21:8.0.1.1.25.5.1.18	SECTION 876.4730	876.4730 Manual gastroenterology-urology surgical instrument and accessories.
21:8.0.1.1.25.5.1.19	SECTION 876.4770	876.4770 Urethrotome.
21:8.0.1.1.25.5.1.20	SECTION 876.4890	876.4890 Urological table and accessories.
21:8.0.1.1.25.6	SUBPART F	Subpart F - Therapeutic Devices
21:8.0.1.1.25.6.1.1	SECTION 876.5010	876.5010 Biliary catheter and accessories.
21:8.0.1.1.25.6.1.2	SECTION 876.5011	876.5011 Metallic biliary stent system for benign strictures.
21:8.0.1.1.25.6.1.3	SECTION 876.5012	876.5012 Biliary stent, drain, and dilator accessories.
21:8.0.1.1.25.6.1.4	SECTION 876.5015	876.5015 Pancreatic drainage stent and delivery system.
21:8.0.1.1.25.6.1.5	SECTION 876.5020	876.5020 External penile rigidity devices.
21:8.0.1.1.25.6.1.6	SECTION 876.5025	876.5025 Vibrator for climax control of premature ejaculation.
21:8.0.1.1.25.6.1.7	SECTION 876.5030	876.5030 Continent ileostomy catheter.
21:8.0.1.1.25.6.1.8	SECTION 876.5090	876.5090 Suprapubic urological catheter and accessories.
21:8.0.1.1.25.6.1.9	SECTION 876.5100	876.5100 Suprapubic catheter accessories.
21:8.0.1.1.25.6.1.10	SECTION 876.5130	876.5130 Urological catheter and accessories.
21:8.0.1.1.25.6.1.11	SECTION 876.5140	876.5140 Urethral insert with pump for bladder drainage.
21:8.0.1.1.25.6.1.12	SECTION 876.5160	876.5160 Urological clamp.
21:8.0.1.1.25.6.1.13	SECTION 876.5210	876.5210 Enema kit.
21:8.0.1.1.25.6.1.14	SECTION 876.5220	876.5220 Colonic irrigation system.
21:8.0.1.1.25.6.1.15	SECTION 876.5250	876.5250 Urine collector and accessories.
21:8.0.1.1.25.6.1.16	SECTION 876.5270	876.5270 Implanted electrical urinary continence device.
21:8.0.1.1.25.6.1.17	SECTION 876.5280	876.5280 Implanted mechanical/hydraulic urinary continence device.
21:8.0.1.1.25.6.1.18	SECTION 876.5290	876.5290 Implanted mechanical/hydraulic urinary continence device surgical accessories.
21:8.0.1.1.25.6.1.19	SECTION 876.5310	876.5310 Nonimplanted, peripheral electrical continence device.
21:8.0.1.1.25.6.1.20	SECTION 876.5320	876.5320 Nonimplanted electrical continence device.
21:8.0.1.1.25.6.1.21	SECTION 876.5365	876.5365 Esophageal dilator.
21:8.0.1.1.25.6.1.22	SECTION 876.5450	876.5450 Rectal dilator.
21:8.0.1.1.25.6.1.23	SECTION 876.5470	876.5470 Ureteral dilator.
21:8.0.1.1.25.6.1.24	SECTION 876.5520	876.5520 Urethral dilator.
21:8.0.1.1.25.6.1.25	SECTION 876.5530	876.5530 Implantable transprostatic tissue retractor system.
21:8.0.1.1.25.6.1.26	SECTION 876.5540	876.5540 Blood access device and accessories.
21:8.0.1.1.25.6.1.27	SECTION 876.5550	876.5550 Prostatic artery embolization device.
21:8.0.1.1.25.6.1.28	SECTION 876.5600	876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
21:8.0.1.1.25.6.1.29	SECTION 876.5630	876.5630 Peritoneal dialysis system and accessories.
21:8.0.1.1.25.6.1.30	SECTION 876.5665	876.5665 Water purification system for hemodialysis.
21:8.0.1.1.25.6.1.31	SECTION 876.5820	876.5820 Hemodialysis system and accessories.
21:8.0.1.1.25.6.1.32	SECTION 876.5830	876.5830 Hemodialyzer with disposable insert (Kiil type).
21:8.0.1.1.25.6.1.33	SECTION 876.5860	876.5860 High permeability hemodialysis system.
21:8.0.1.1.25.6.1.34	SECTION 876.5870	876.5870 Sorbent hemoperfusion system.
21:8.0.1.1.25.6.1.35	SECTION 876.5880	876.5880 Isolated kidney perfusion and transport system and accessories.
21:8.0.1.1.25.6.1.36	SECTION 876.5885	876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.
21:8.0.1.1.25.6.1.37	SECTION 876.5895	876.5895 Ostomy irrigator.
21:8.0.1.1.25.6.1.38	SECTION 876.5900	876.5900 Ostomy pouch and accessories.
21:8.0.1.1.25.6.1.39	SECTION 876.5920	876.5920 Protective garment for incontinence.
21:8.0.1.1.25.6.1.40	SECTION 876.5930	876.5930 Rectal control system.
21:8.0.1.1.25.6.1.41	SECTION 876.5955	876.5955 Peritoneo-venous shunt.
21:8.0.1.1.25.6.1.42	SECTION 876.5970	876.5970 Hernia support.
21:8.0.1.1.25.6.1.43	SECTION 876.5980	876.5980 Gastrointestinal tube and accessories.
21:8.0.1.1.25.6.1.44	SECTION 876.5981	876.5981 Oral removable palatal space occupying device for weight management and/or weight loss.
21:8.0.1.1.25.6.1.45	SECTION 876.5985	876.5985 Enzyme packed cartridge.
21:8.0.1.1.25.6.1.46	SECTION 876.5990	876.5990 Extracorporeal shock wave lithotripter.
21:8.0.1.1.26	PART 878	PART 878 - GENERAL AND PLASTIC SURGERY DEVICES
21:8.0.1.1.26.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.26.1.1.1	SECTION 878.1	878.1 Scope.
21:8.0.1.1.26.1.1.2	SECTION 878.3	878.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.26.1.1.3	SECTION 878.9	878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.26.2	SUBPART B	Subpart B - Diagnostic Devices
21:8.0.1.1.26.2.1.1	SECTION 878.1800	878.1800 Speculum and accessories.
21:8.0.1.1.26.3	SUBPART C	Subpart C [Reserved]
21:8.0.1.1.26.4	SUBPART D	Subpart D - Prosthetic Devices
21:8.0.1.1.26.4.1.1	SECTION 878.3250	878.3250 External facial fracture fixation appliance.
21:8.0.1.1.26.4.1.2	SECTION 878.3300	878.3300 Surgical mesh.
21:8.0.1.1.26.4.1.3	SECTION 878.3500	878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
21:8.0.1.1.26.4.1.4	SECTION 878.3530	878.3530 Silicone inflatable breast prosthesis.
21:8.0.1.1.26.4.1.5	SECTION 878.3540	878.3540 Silicone gel-filled breast prosthesis.
21:8.0.1.1.26.4.1.6	SECTION 878.3550	878.3550 Chin prosthesis.
21:8.0.1.1.26.4.1.7	SECTION 878.3590	878.3590 Ear prosthesis.
21:8.0.1.1.26.4.1.8	SECTION 878.3610	878.3610 Esophageal prosthesis.
21:8.0.1.1.26.4.1.9	SECTION 878.3680	878.3680 Nose prosthesis.
21:8.0.1.1.26.4.1.10	SECTION 878.3720	878.3720 Tracheal prosthesis.
21:8.0.1.1.26.4.1.11	SECTION 878.3750	878.3750 External prosthesis adhesive.
21:8.0.1.1.26.4.1.12	SECTION 878.3800	878.3800 External aesthetic restoration prosthesis.
21:8.0.1.1.26.4.1.13	SECTION 878.3900	878.3900 Inflatable extremity splint.
21:8.0.1.1.26.4.1.14	SECTION 878.3910	878.3910 Noninflatable extremity splint.
21:8.0.1.1.26.4.1.15	SECTION 878.3925	878.3925 Plastic surgery kit and accessories.
21:8.0.1.1.26.5	SUBPART E	Subpart E - Surgical Devices
21:8.0.1.1.26.5.1.1	SECTION 878.4010	878.4010 Tissue adhesive.
21:8.0.1.1.26.5.1.2	SECTION 878.4011	878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
21:8.0.1.1.26.5.1.3	SECTION 878.4014	878.4014 Nonresorbable gauze/sponge for external use.
21:8.0.1.1.26.5.1.4	SECTION 878.4015	878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
21:8.0.1.1.26.5.1.5	SECTION 878.4018	878.4018 Hydrophilic wound dressing.
21:8.0.1.1.26.5.1.6	SECTION 878.4020	878.4020 Occlusive wound dressing.
21:8.0.1.1.26.5.1.7	SECTION 878.4022	878.4022 Hydrogel wound dressing and burn dressing.
21:8.0.1.1.26.5.1.8	SECTION 878.4025	878.4025 Silicone sheeting.
21:8.0.1.1.26.5.1.9	SECTION 878.4040	878.4040 Surgical apparel.
21:8.0.1.1.26.5.1.10	SECTION 878.4100	878.4100 Organ bag.
21:8.0.1.1.26.5.1.11	SECTION 878.4160	878.4160 Surgical camera and accessories.
21:8.0.1.1.26.5.1.12	SECTION 878.4165	878.4165 Wound autofluorescence imaging device.
21:8.0.1.1.26.5.1.13	SECTION 878.4200	878.4200 Introduction/drainage catheter and accessories.
21:8.0.1.1.26.5.1.14	SECTION 878.4300	878.4300 Implantable clip.
21:8.0.1.1.26.5.1.15	SECTION 878.4320	878.4320 Removable skin clip.
21:8.0.1.1.26.5.1.16	SECTION 878.4340	878.4340 Contact cooling system for aesthetic use.
21:8.0.1.1.26.5.1.17	SECTION 878.4350	878.4350 Cryosurgical unit and accessories.
21:8.0.1.1.26.5.1.18	SECTION 878.4360	878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
21:8.0.1.1.26.5.1.19	SECTION 878.4370	878.4370 Surgical drape and drape accessories.
21:8.0.1.1.26.5.1.20	SECTION 878.4371	878.4371 Irrigating wound retractor device.
21:8.0.1.1.26.5.1.21	SECTION 878.4380	878.4380 Drape adhesive.
21:8.0.1.1.26.5.1.22	SECTION 878.4400	878.4400 Electrosurgical cutting and coagulation device and accessories.
21:8.0.1.1.26.5.1.23	SECTION 878.4410	878.4410 Low energy ultrasound wound cleaner.
21:8.0.1.1.26.5.1.24	SECTION 878.4420	878.4420 Electrosurgical device for over-the-counter aesthetic use.
21:8.0.1.1.26.5.1.25	SECTION 878.4430	878.4430 Microneedling device for aesthetic use.
21:8.0.1.1.26.5.1.26	SECTION 878.4440	878.4440 Eye pad.
21:8.0.1.1.26.5.1.27	SECTION 878.4450	878.4450 Nonabsorbable gauze for internal use.
21:8.0.1.1.26.5.1.28	SECTION 878.4452	878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.
21:8.0.1.1.26.5.1.29	SECTION 878.4454	878.4454 Non-absorbable, hemostatic gauze for temporary internal use.
21:8.0.1.1.26.5.1.30	SECTION 878.4456	878.4456 Hemostatic device for intraluminal gastrointestinal use.
21:8.0.1.1.26.5.1.31	SECTION 878.4460	878.4460 Non-powdered surgeon's glove.
21:8.0.1.1.26.5.1.32	SECTION 878.4470	878.4470 Surgeon's gloving cream.
21:8.0.1.1.26.5.1.33	SECTION 878.4490	878.4490 Absorbable hemostatic agent and dressing.
21:8.0.1.1.26.5.1.34	SECTION 878.4493	878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
21:8.0.1.1.26.5.1.35	SECTION 878.4494	878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
21:8.0.1.1.26.5.1.36	SECTION 878.4495	878.4495 Stainless steel suture.
21:8.0.1.1.26.5.1.37	SECTION 878.4520	878.4520 Polytetrafluoroethylene injectable.
21:8.0.1.1.26.5.1.38	SECTION 878.4580	878.4580 Surgical lamp.
21:8.0.1.1.26.5.1.39	SECTION 878.4590	878.4590 Focused ultrasound stimulator system for aesthetic use.
21:8.0.1.1.26.5.1.40	SECTION 878.4630	878.4630 Ultraviolet lamp for dermatologic disorders.
21:8.0.1.1.26.5.1.41	SECTION 878.4635	878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
21:8.0.1.1.26.5.1.42	SECTION 878.4660	878.4660 Skin marker.
21:8.0.1.1.26.5.1.43	SECTION 878.4670	878.4670 Internal tissue marker.
21:8.0.1.1.26.5.1.44	SECTION 878.4680	878.4680 Nonpowered, single patient, portable suction apparatus.
21:8.0.1.1.26.5.1.45	SECTION 878.4683	878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
21:8.0.1.1.26.5.1.46	SECTION 878.4685	878.4685 Extracorporeal shock wave device for treatment of chronic wounds.
21:8.0.1.1.26.5.1.47	SECTION 878.4700	878.4700 Surgical microscope and accessories.
21:8.0.1.1.26.5.1.48	SECTION 878.4730	878.4730 Surgical skin degreaser or adhesive tape solvent.
21:8.0.1.1.26.5.1.49	SECTION 878.4750	878.4750 Implantable staple.
21:8.0.1.1.26.5.1.50	SECTION 878.4755	878.4755 Absorbable lung biopsy plug.
21:8.0.1.1.26.5.1.51	SECTION 878.4760	878.4760 Removable skin staple.
21:8.0.1.1.26.5.1.52	SECTION 878.4780	878.4780 Powered suction pump.
21:8.0.1.1.26.5.1.53	SECTION 878.4790	878.4790 Powered surgical instrument for improvement in the appearance of cellulite.
21:8.0.1.1.26.5.1.54	SECTION 878.4800	878.4800 Manual surgical instrument for general use.
21:8.0.1.1.26.5.1.55	SECTION 878.4810	878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
21:8.0.1.1.26.5.1.56	SECTION 878.4815	878.4815 Magnetic surgical instrument system.
21:8.0.1.1.26.5.1.57	SECTION 878.4820	878.4820 Surgical instrument motors and accessories/attachments.
21:8.0.1.1.26.5.1.58	SECTION 878.4830	878.4830 Absorbable surgical gut suture.
21:8.0.1.1.26.5.1.59	SECTION 878.4840	878.4840 Absorbable polydioxanone surgical suture.
21:8.0.1.1.26.5.1.60	SECTION 878.4860	878.4860 Light based energy source device for topical application.
21:8.0.1.1.26.5.1.61	SECTION 878.4930	878.4930 Suture retention device.
21:8.0.1.1.26.5.1.62	SECTION 878.4950	878.4950 Manual operating table and accessories and manual operating chair and accessories.
21:8.0.1.1.26.5.1.63	SECTION 878.4960	878.4960 Operating tables and accessories and operating chairs and accessories.
21:8.0.1.1.26.5.1.64	SECTION 878.5000	878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
21:8.0.1.1.26.5.1.65	SECTION 878.5010	878.5010 Nonabsorbable polypropylene surgical suture.
21:8.0.1.1.26.5.1.66	SECTION 878.5020	878.5020 Nonabsorbable polyamide surgical suture.
21:8.0.1.1.26.5.1.67	SECTION 878.5030	878.5030 Natural nonabsorbable silk surgical suture.
21:8.0.1.1.26.5.1.68	SECTION 878.5035	878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
21:8.0.1.1.26.5.1.69	SECTION 878.5040	878.5040 Suction lipoplasty system.
21:8.0.1.1.26.5.1.70	SECTION 878.5050	878.5050 Surgical smoke precipitator.
21:8.0.1.1.26.6	SUBPART F	Subpart F - Therapeutic Devices
21:8.0.1.1.26.6.1.1	SECTION 878.5070	878.5070 Air-handling apparatus for a surgical operating room.
21:8.0.1.1.26.6.1.2	SECTION 878.5080	878.5080 Air-handling apparatus accessory.
21:8.0.1.1.26.6.1.3	SECTION 878.5350	878.5350 Needle-type epilator.
21:8.0.1.1.26.6.1.4	SECTION 878.5360	878.5360 Tweezer-type epilator.
21:8.0.1.1.26.6.1.5	SECTION 878.5400	878.5400 Low level laser system for aesthetic use
21:8.0.1.1.26.6.1.6	SECTION 878.5650	878.5650 Topical oxygen chamber for extremities.
21:8.0.1.1.26.6.1.7	SECTION 878.5900	878.5900 Nonpneumatic tourniquet.
21:8.0.1.1.26.6.1.8	SECTION 878.5910	878.5910 Pneumatic tourniquet.
21:8.0.1.1.27	PART 880	PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES
21:8.0.1.1.27.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.27.1.1.1	SECTION 880.1	880.1 Scope.
21:8.0.1.1.27.1.1.2	SECTION 880.3	880.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.27.1.1.3	SECTION 880.9	880.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.27.2	SUBPART B	Subpart B [Reserved]
21:8.0.1.1.27.3	SUBPART C	Subpart C - General Hospital and Personal Use Monitoring Devices
21:8.0.1.1.27.3.1.1	SECTION 880.2200	880.2200 Liquid crystal forehead temperature strip.
21:8.0.1.1.27.3.1.2	SECTION 880.2400	880.2400 Bed-patient monitor.
21:8.0.1.1.27.3.1.3	SECTION 880.2420	880.2420 Electronic monitor for gravity flow infusion systems.
21:8.0.1.1.27.3.1.4	SECTION 880.2460	880.2460 Electrically powered spinal fluid pressure monitor.
21:8.0.1.1.27.3.1.5	SECTION 880.2500	880.2500 Spinal fluid manometer.
21:8.0.1.1.27.3.1.6	SECTION 880.2700	880.2700 Stand-on patient scale.
21:8.0.1.1.27.3.1.7	SECTION 880.2720	880.2720 Patient scale.
21:8.0.1.1.27.3.1.8	SECTION 880.2740	880.2740 Surgical sponge scale.
21:8.0.1.1.27.3.1.9	SECTION 880.2750	880.2750 Image processing device for estimation of external blood loss.
21:8.0.1.1.27.3.1.10	SECTION 880.2800	880.2800 Sterilization process indicator.
21:8.0.1.1.27.3.1.11	SECTION 880.2900	880.2900 Clinical color change thermometer.
21:8.0.1.1.27.3.1.12	SECTION 880.2910	880.2910 Clinical electronic thermometer.
21:8.0.1.1.27.3.1.13	SECTION 880.2920	880.2920 Clinical mercury thermometer.
21:8.0.1.1.27.3.1.14	SECTION 880.2930	880.2930 Apgar timer.
21:8.0.1.1.27.4	SUBPART D	Subparts D-E [Reserved]
21:8.0.1.1.27.5	SUBPART F	Subpart F - General Hospital and Personal Use Therapeutic Devices
21:8.0.1.1.27.5.1.1	SECTION 880.5025	880.5025 I.V. container.
21:8.0.1.1.27.5.1.2	SECTION 880.5045	880.5045 Medical recirculating air cleaner.
21:8.0.1.1.27.5.1.3	SECTION 880.5075	880.5075 Elastic bandage.
21:8.0.1.1.27.5.1.4	SECTION 880.5090	880.5090 Liquid bandage.
21:8.0.1.1.27.5.1.5	SECTION 880.5100	880.5100 AC-powered adjustable hospital bed.
21:8.0.1.1.27.5.1.6	SECTION 880.5110	880.5110 Hydraulic adjustable hospital bed.
21:8.0.1.1.27.5.1.7	SECTION 880.5120	880.5120 Manual adjustable hospital bed.
21:8.0.1.1.27.5.1.8	SECTION 880.5130	880.5130 Infant radiant warmer.
21:8.0.1.1.27.5.1.9	SECTION 880.5140	880.5140 Pediatric medical crib.
21:8.0.1.1.27.5.1.10	SECTION 880.5145	880.5145 Medical bassinet.
21:8.0.1.1.27.5.1.11	SECTION 880.5150	880.5150 Nonpowered flotation therapy mattress.
21:8.0.1.1.27.5.1.12	SECTION 880.5160	880.5160 Therapeutic medical binder.
21:8.0.1.1.27.5.1.13	SECTION 880.5180	880.5180 Burn sheet.
21:8.0.1.1.27.5.1.14	SECTION 880.5200	880.5200 Intravascular catheter.
21:8.0.1.1.27.5.1.15	SECTION 880.5210	880.5210 Intravascular catheter securement device.
21:8.0.1.1.27.5.1.16	SECTION 880.5240	880.5240 Medical adhesive tape and adhesive bandage.
21:8.0.1.1.27.5.1.17	SECTION 880.5270	880.5270 Neonatal eye pad.
21:8.0.1.1.27.5.1.18	SECTION 880.5300	880.5300 Medical absorbent fiber.
21:8.0.1.1.27.5.1.19	SECTION 880.5400	880.5400 Neonatal incubator.
21:8.0.1.1.27.5.1.20	SECTION 880.5410	880.5410 Neonatal transport incubator.
21:8.0.1.1.27.5.1.21	SECTION 880.5420	880.5420 Pressure infusor for an I.V. bag.
21:8.0.1.1.27.5.1.22	SECTION 880.5430	880.5430 Nonelectrically powered fluid injector.
21:8.0.1.1.27.5.1.23	SECTION 880.5440	880.5440 Intravascular administration set.
21:8.0.1.1.27.5.1.24	SECTION 880.5445	880.5445 Intravascular administration set, automated air removal system.
21:8.0.1.1.27.5.1.25	SECTION 880.5450	880.5450 Patient care reverse isolation chamber.
21:8.0.1.1.27.5.1.26	SECTION 880.5475	880.5475 Jet lavage.
21:8.0.1.1.27.5.1.27	SECTION 880.5500	880.5500 AC-powered patient lift.
21:8.0.1.1.27.5.1.28	SECTION 880.5510	880.5510 Non-AC-powered patient lift.
21:8.0.1.1.27.5.1.29	SECTION 880.5550	880.5550 Alternating pressure air flotation mattress.
21:8.0.1.1.27.5.1.30	SECTION 880.5560	880.5560 Temperature regulated water mattress.
21:8.0.1.1.27.5.1.31	SECTION 880.5570	880.5570 Hypodermic single lumen needle.
21:8.0.1.1.27.5.1.32	SECTION 880.5580	880.5580 Acupuncture needle.
21:8.0.1.1.27.5.1.33	SECTION 880.5630	880.5630 Nipple shield.
21:8.0.1.1.27.5.1.34	SECTION 880.5640	880.5640 Lamb feeding nipple.
21:8.0.1.1.27.5.1.35	SECTION 880.5680	880.5680 Pediatric position holder.
21:8.0.1.1.27.5.1.36	SECTION 880.5700	880.5700 Neonatal phototherapy unit.
21:8.0.1.1.27.5.1.37	SECTION 880.5725	880.5725 Infusion pump.
21:8.0.1.1.27.5.1.38	SECTION 880.5740	880.5740 Suction snakebite kit.
21:8.0.1.1.27.5.1.39	SECTION 880.5760	880.5760 Chemical cold pack snakebite kit.
21:8.0.1.1.27.5.1.40	SECTION 880.5780	880.5780 Medical support stocking.
21:8.0.1.1.27.5.1.41	SECTION 880.5820	880.5820 Therapeutic scrotal support.
21:8.0.1.1.27.5.1.42	SECTION 880.5860	880.5860 Piston syringe.
21:8.0.1.1.27.5.1.43	SECTION 880.5950	880.5950 Umbilical occlusion device.
21:8.0.1.1.27.5.1.44	SECTION 880.5960	880.5960 Lice removal kit.
21:8.0.1.1.27.5.1.45	SECTION 880.5965	880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
21:8.0.1.1.27.5.1.46	SECTION 880.5970	880.5970 Percutaneous, implanted, long-term intravascular catheter.
21:8.0.1.1.27.6	SUBPART G	Subpart G - General Hospital and Personal Use Miscellaneous Devices
21:8.0.1.1.27.6.1.1	SECTION 880.6025	880.6025 Absorbent tipped applicator.
21:8.0.1.1.27.6.1.2	SECTION 880.6050	880.6050 Ice bag.
21:8.0.1.1.27.6.1.3	SECTION 880.6060	880.6060 Medical disposable bedding.
21:8.0.1.1.27.6.1.4	SECTION 880.6070	880.6070 Bed board.
21:8.0.1.1.27.6.1.5	SECTION 880.6080	880.6080 Cardiopulmonary resuscitation board.
21:8.0.1.1.27.6.1.6	SECTION 880.6085	880.6085 Hot/cold water bottle.
21:8.0.1.1.27.6.1.7	SECTION 880.6100	880.6100 Ethylene oxide gas aerator cabinet.
21:8.0.1.1.27.6.1.8	SECTION 880.6140	880.6140 Medical chair and table.
21:8.0.1.1.27.6.1.9	SECTION 880.6150	880.6150 Ultrasonic cleaner for medical instruments.
21:8.0.1.1.27.6.1.10	SECTION 880.6175	880.6175 [Reserved]
21:8.0.1.1.27.6.1.11	SECTION 880.6185	880.6185 Cast cover.
21:8.0.1.1.27.6.1.12	SECTION 880.6190	880.6190 Mattress cover for medical purposes.
21:8.0.1.1.27.6.1.13	SECTION 880.6200	880.6200 Ring cutter.
21:8.0.1.1.27.6.1.14	SECTION 880.6210	880.6210 Sharps needle destruction device.
21:8.0.1.1.27.6.1.15	SECTION 880.6230	880.6230 Tongue depressor.
21:8.0.1.1.27.6.1.16	SECTION 880.6250	880.6250 Non-powdered patient examination glove.
21:8.0.1.1.27.6.1.17	SECTION 880.6260	880.6260 Filtering facepiece respirator for use by the general public in public health medical emergencies.
21:8.0.1.1.27.6.1.18	SECTION 880.6265	880.6265 Examination gown.
21:8.0.1.1.27.6.1.19	SECTION 880.6280	880.6280 Medical insole.
21:8.0.1.1.27.6.1.20	SECTION 880.6300	880.6300 Implantable radiofrequency transponder system for patient identification and health information.
21:8.0.1.1.27.6.1.21	SECTION 880.6305	880.6305 Ingestible event marker.
21:8.0.1.1.27.6.1.22	SECTION 880.6310	880.6310 Medical device data system.
21:8.0.1.1.27.6.1.23	SECTION 880.6315	880.6315 Remote Medication Management System.
21:8.0.1.1.27.6.1.24	SECTION 880.6320	880.6320 AC-powered medical examination light.
21:8.0.1.1.27.6.1.25	SECTION 880.6350	880.6350 Battery-powered medical examination light.
21:8.0.1.1.27.6.1.26	SECTION 880.6375	880.6375 Patient lubricant.
21:8.0.1.1.27.6.1.27	SECTION 880.6430	880.6430 Liquid medication dispenser.
21:8.0.1.1.27.6.1.28	SECTION 880.6450	880.6450 Skin pressure protectors.
21:8.0.1.1.27.6.1.29	SECTION 880.6500	880.6500 Medical ultraviolet air purifier.
21:8.0.1.1.27.6.1.30	SECTION 880.6600	880.6600 Ultraviolet (UV) radiation chamber disinfection device.
21:8.0.1.1.27.6.1.31	SECTION 880.6710	880.6710 Medical ultraviolet water purifier.
21:8.0.1.1.27.6.1.32	SECTION 880.6730	880.6730 Body waste receptacle.
21:8.0.1.1.27.6.1.33	SECTION 880.6740	880.6740 Vacuum-powered body fluid suction apparatus.
21:8.0.1.1.27.6.1.34	SECTION 880.6760	880.6760 Protective restraint.
21:8.0.1.1.27.6.1.35	SECTION 880.6775	880.6775 Powered patient transfer device.
21:8.0.1.1.27.6.1.36	SECTION 880.6785	880.6785 Manual patient transfer device.
21:8.0.1.1.27.6.1.37	SECTION 880.6800	880.6800 Washers for body waste receptacles.
21:8.0.1.1.27.6.1.38	SECTION 880.6820	880.6820 Medical disposable scissors.
21:8.0.1.1.27.6.1.39	SECTION 880.6850	880.6850 Sterilization wrap.
21:8.0.1.1.27.6.1.40	SECTION 880.6860	880.6860 Ethylene oxide gas sterilizer.
21:8.0.1.1.27.6.1.41	SECTION 880.6870	880.6870 Dry-heat sterilizer.
21:8.0.1.1.27.6.1.42	SECTION 880.6880	880.6880 Steam sterilizer.
21:8.0.1.1.27.6.1.43	SECTION 880.6885	880.6885 Liquid chemical sterilants/high level disinfectants.
21:8.0.1.1.27.6.1.44	SECTION 880.6890	880.6890 General purpose disinfectants.
21:8.0.1.1.27.6.1.45	SECTION 880.6900	880.6900 Hand-carried stretcher.
21:8.0.1.1.27.6.1.46	SECTION 880.6910	880.6910 Wheeled stretcher.
21:8.0.1.1.27.6.1.47	SECTION 880.6920	880.6920 Syringe needle introducer.
21:8.0.1.1.27.6.1.48	SECTION 880.6960	880.6960 Irrigating syringe.
21:8.0.1.1.27.6.1.49	SECTION 880.6970	880.6970 Liquid crystal vein locator.
21:8.0.1.1.27.6.1.50	SECTION 880.6980	880.6980 Vein stabilizer.
21:8.0.1.1.27.6.1.51	SECTION 880.6990	880.6990 Infusion stand.
21:8.0.1.1.27.6.1.52	SECTION 880.6991	880.6991 Medical washer.
21:8.0.1.1.27.6.1.53	SECTION 880.6992	880.6992 Medical washer-disinfector.
21:8.0.1.1.28	PART 882	PART 882 - NEUROLOGICAL DEVICES
21:8.0.1.1.28.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.28.1.1.1	SECTION 882.1	882.1 Scope.
21:8.0.1.1.28.1.1.2	SECTION 882.3	882.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.28.1.1.3	SECTION 882.9	882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.28.2	SUBPART B	Subpart B - Neurological Diagnostic Devices
21:8.0.1.1.28.2.1.1	SECTION 882.1020	882.1020 Rigidity analyzer.
21:8.0.1.1.28.2.1.2	SECTION 882.1030	882.1030 Ataxiagraph.
21:8.0.1.1.28.2.1.3	SECTION 882.1200	882.1200 Two-point discriminator.
21:8.0.1.1.28.2.1.4	SECTION 882.1240	882.1240 Echoencephalograph.
21:8.0.1.1.28.2.1.5	SECTION 882.1275	882.1275 Electroconductive media.
21:8.0.1.1.28.2.1.6	SECTION 882.1310	882.1310 Cortical electrode.
21:8.0.1.1.28.2.1.7	SECTION 882.1320	882.1320 Cutaneous electrode.
21:8.0.1.1.28.2.1.8	SECTION 882.1330	882.1330 Depth electrode.
21:8.0.1.1.28.2.1.9	SECTION 882.1340	882.1340 Nasopharyngeal electrode.
21:8.0.1.1.28.2.1.10	SECTION 882.1350	882.1350 Needle electrode.
21:8.0.1.1.28.2.1.11	SECTION 882.1400	882.1400 Electroencephalograph.
21:8.0.1.1.28.2.1.12	SECTION 882.1410	882.1410 Electroencephalograph electrode/lead tester.
21:8.0.1.1.28.2.1.13	SECTION 882.1420	882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
21:8.0.1.1.28.2.1.14	SECTION 882.1430	882.1430 Electroencephalograph test signal generator.
21:8.0.1.1.28.2.1.15	SECTION 882.1440	882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid.
21:8.0.1.1.28.2.1.16	SECTION 882.1450	882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.
21:8.0.1.1.28.2.1.17	SECTION 882.1460	882.1460 Nystagmograph.
21:8.0.1.1.28.2.1.18	SECTION 882.1470	882.1470 Computerized cognitive assessment aid.
21:8.0.1.1.28.2.1.19	SECTION 882.1471	882.1471 Computerized cognitive assessment aid for concussion.
21:8.0.1.1.28.2.1.20	SECTION 882.1480	882.1480 Neurological endoscope.
21:8.0.1.1.28.2.1.21	SECTION 882.1500	882.1500 Esthesiometer.
21:8.0.1.1.28.2.1.22	SECTION 882.1525	882.1525 Tuning fork.
21:8.0.1.1.28.2.1.23	SECTION 882.1540	882.1540 Galvanic skin response measurement device.
21:8.0.1.1.28.2.1.24	SECTION 882.1550	882.1550 Nerve conduction velocity measurement device.
21:8.0.1.1.28.2.1.25	SECTION 882.1560	882.1560 Skin potential measurement device.
21:8.0.1.1.28.2.1.26	SECTION 882.1561	882.1561 Evoked photon image capture device.
21:8.0.1.1.28.2.1.27	SECTION 882.1570	882.1570 Powered direct-contact temperature measurement device.
21:8.0.1.1.28.2.1.28	SECTION 882.1580	882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
21:8.0.1.1.28.2.1.29	SECTION 882.1610	882.1610 Alpha monitor.
21:8.0.1.1.28.2.1.30	SECTION 882.1620	882.1620 Intracranial pressure monitoring device.
21:8.0.1.1.28.2.1.31	SECTION 882.1630	882.1630 Cranial motion measurement device.
21:8.0.1.1.28.2.1.32	SECTION 882.1700	882.1700 Percussor.
21:8.0.1.1.28.2.1.33	SECTION 882.1750	882.1750 Pinwheel.
21:8.0.1.1.28.2.1.34	SECTION 882.1790	882.1790 Ocular plethysmograph.
21:8.0.1.1.28.2.1.35	SECTION 882.1825	882.1825 Rheoencephalograph.
21:8.0.1.1.28.2.1.36	SECTION 882.1835	882.1835 Physiological signal amplifier.
21:8.0.1.1.28.2.1.37	SECTION 882.1845	882.1845 Physiological signal conditioner.
21:8.0.1.1.28.2.1.38	SECTION 882.1855	882.1855 Electroencephalogram (EEG) telemetry system.
21:8.0.1.1.28.2.1.39	SECTION 882.1870	882.1870 Evoked response electrical stimulator.
21:8.0.1.1.28.2.1.40	SECTION 882.1880	882.1880 Evoked response mechanical stimulator.
21:8.0.1.1.28.2.1.41	SECTION 882.1890	882.1890 Evoked response photic stimulator.
21:8.0.1.1.28.2.1.42	SECTION 882.1900	882.1900 Evoked response auditory stimulator.
21:8.0.1.1.28.2.1.43	SECTION 882.1925	882.1925 Ultrasonic scanner calibration test block.
21:8.0.1.1.28.2.1.44	SECTION 882.1935	882.1935 Near Infrared (NIR) Brain Hematoma Detector.
21:8.0.1.1.28.2.1.45	SECTION 882.1950	882.1950 Tremor transducer.
21:8.0.1.1.28.3	SUBPART C	Subparts C-D [Reserved]
21:8.0.1.1.28.4	SUBPART E	Subpart E - Neurological Surgical Devices
21:8.0.1.1.28.4.1.1	SECTION 882.4030	882.4030 Skull plate anvil.
21:8.0.1.1.28.4.1.2	SECTION 882.4060	882.4060 Ventricular cannula.
21:8.0.1.1.28.4.1.3	SECTION 882.4100	882.4100 Ventricular catheter.
21:8.0.1.1.28.4.1.4	SECTION 882.4125	882.4125 Neurosurgical chair.
21:8.0.1.1.28.4.1.5	SECTION 882.4150	882.4150 Scalp clip.
21:8.0.1.1.28.4.1.6	SECTION 882.4175	882.4175 Aneurysm clip applier.
21:8.0.1.1.28.4.1.7	SECTION 882.4190	882.4190 Clip forming/cutting instrument.
21:8.0.1.1.28.4.1.8	SECTION 882.4200	882.4200 Clip removal instrument.
21:8.0.1.1.28.4.1.9	SECTION 882.4215	882.4215 Clip rack.
21:8.0.1.1.28.4.1.10	SECTION 882.4250	882.4250 Cryogenic surgical device.
21:8.0.1.1.28.4.1.11	SECTION 882.4275	882.4275 Dowel cutting instrument.
21:8.0.1.1.28.4.1.12	SECTION 882.4300	882.4300 Manual cranial drills, burrs, trephines, and their accessories
21:8.0.1.1.28.4.1.13	SECTION 882.4305	882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.
21:8.0.1.1.28.4.1.14	SECTION 882.4310	882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
21:8.0.1.1.28.4.1.15	SECTION 882.4325	882.4325 Cranial drill handpiece (brace).
21:8.0.1.1.28.4.1.16	SECTION 882.4360	882.4360 Electric cranial drill motor.
21:8.0.1.1.28.4.1.17	SECTION 882.4370	882.4370 Pneumatic cranial drill motor.
21:8.0.1.1.28.4.1.18	SECTION 882.4400	882.4400 Radiofrequency lesion generator.
21:8.0.1.1.28.4.1.19	SECTION 882.4440	882.4440 Neurosurgical headrests.
21:8.0.1.1.28.4.1.20	SECTION 882.4460	882.4460 Neurosurgical head holder (skull clamp).
21:8.0.1.1.28.4.1.21	SECTION 882.4500	882.4500 Cranioplasty material forming instrument.
21:8.0.1.1.28.4.1.22	SECTION 882.4525	882.4525 Microsurgical instrument.
21:8.0.1.1.28.4.1.23	SECTION 882.4535	882.4535 Nonpowered neurosurgical instrument.
21:8.0.1.1.28.4.1.24	SECTION 882.4545	882.4545 Shunt system implantation instrument.
21:8.0.1.1.28.4.1.25	SECTION 882.4560	882.4560 Stereotaxic instrument.
21:8.0.1.1.28.4.1.26	SECTION 882.4600	882.4600 Leukotome.
21:8.0.1.1.28.4.1.27	SECTION 882.4650	882.4650 Neurosurgical suture needle.
21:8.0.1.1.28.4.1.28	SECTION 882.4700	882.4700 Neurosurgical paddie.
21:8.0.1.1.28.4.1.29	SECTION 882.4725	882.4725 Radiofrequency lesion probe.
21:8.0.1.1.28.4.1.30	SECTION 882.4750	882.4750 Skull punch.
21:8.0.1.1.28.4.1.31	SECTION 882.4800	882.4800 Self-retaining retractor for neurosurgery.
21:8.0.1.1.28.4.1.32	SECTION 882.4840	882.4840 Manual rongeur.
21:8.0.1.1.28.4.1.33	SECTION 882.4845	882.4845 Powered rongeur.
21:8.0.1.1.28.4.1.34	SECTION 882.4900	882.4900 Skullplate screwdriver.
21:8.0.1.1.28.5	SUBPART F	Subpart F - Neurological Therapeutic Devices
21:8.0.1.1.28.5.1.1	SECTION 882.5030	882.5030 Methyl methacrylate for aneurysmorrhaphy.
21:8.0.1.1.28.5.1.2	SECTION 882.5050	882.5050 Biofeedback device.
21:8.0.1.1.28.5.1.3	SECTION 882.5070	882.5070 Bite block.
21:8.0.1.1.28.5.1.4	SECTION 882.5150	882.5150 Intravascular occluding catheter.
21:8.0.1.1.28.5.1.5	SECTION 882.5175	882.5175 Carotid artery clamp.
21:8.0.1.1.28.5.1.6	SECTION 882.5200	882.5200 Aneurysm clip.
21:8.0.1.1.28.5.1.7	SECTION 882.5225	882.5225 Implanted malleable clip.
21:8.0.1.1.28.5.1.8	SECTION 882.5235	882.5235 Aversive conditioning device.
21:8.0.1.1.28.5.1.9	SECTION 882.5250	882.5250 Burr hole cover.
21:8.0.1.1.28.5.1.10	SECTION 882.5275	882.5275 Nerve cuff.
21:8.0.1.1.28.5.1.11	SECTION 882.5300	882.5300 Methyl methacrylate for cranioplasty.
21:8.0.1.1.28.5.1.12	SECTION 882.5320	882.5320 Preformed alterable cranioplasty plate.
21:8.0.1.1.28.5.1.13	SECTION 882.5330	882.5330 Preformed nonalterable cranioplasty plate.
21:8.0.1.1.28.5.1.14	SECTION 882.5360	882.5360 Cranioplasty plate fastener.
21:8.0.1.1.28.5.1.15	SECTION 882.5500	882.5500 Lesion temperature monitor.
21:8.0.1.1.28.5.1.16	SECTION 882.5550	882.5550 Central nervous system fluid shunt and components.
21:8.0.1.1.28.5.1.17	SECTION 882.5600	882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
21:8.0.1.1.28.5.1.18	SECTION 882.5700	882.5700 Thermal system for insomnia.
21:8.0.1.1.28.5.1.19	SECTION 882.5800	882.5800 Cranial electrotherapy stimulator.
21:8.0.1.1.28.5.1.20	SECTION 882.5801	882.5801 Computerized behavioral therapy device for psychiatric disorders.
21:8.0.1.1.28.5.1.21	SECTION 882.5802	882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
21:8.0.1.1.28.5.1.22	SECTION 882.5805	882.5805 Repetitive transcranial magnetic stimulation system.
21:8.0.1.1.28.5.1.23	SECTION 882.5808	882.5808 Transcranial magnetic stimulator for headache.
21:8.0.1.1.28.5.1.24	SECTION 882.5810	882.5810 External functional neuromuscular stimulator.
21:8.0.1.1.28.5.1.25	SECTION 882.5820	882.5820 Implanted cerebellar stimulator.
21:8.0.1.1.28.5.1.26	SECTION 882.5830	882.5830 Implanted diaphragmatic/phrenic nerve stimulator.
21:8.0.1.1.28.5.1.27	SECTION 882.5840	882.5840 Implanted intracerebral/subcortical stimulator for pain relief.
21:8.0.1.1.28.5.1.28	SECTION 882.5850	882.5850 Implanted spinal cord stimulator for bladder evacuation.
21:8.0.1.1.28.5.1.29	SECTION 882.5860	882.5860 Implanted neuromuscular stimulator.
21:8.0.1.1.28.5.1.30	SECTION 882.5870	882.5870 Implanted peripheral nerve stimulator for pain relief.
21:8.0.1.1.28.5.1.31	SECTION 882.5880	882.5880 Implanted spinal cord stimulator for pain relief.
21:8.0.1.1.28.5.1.32	SECTION 882.5890	882.5890 Transcutaneous electrical nerve stimulator for pain relief.
21:8.0.1.1.28.5.1.33	SECTION 882.5891	882.5891 Transcutaneous electrical nerve stimulator to treat headache.
21:8.0.1.1.28.5.1.34	SECTION 882.5892	882.5892 External vagal nerve stimulator for headache.
21:8.0.1.1.28.5.1.35	SECTION 882.5893	882.5893 Thermal vestibular stimulator for headache.
21:8.0.1.1.28.5.1.36	SECTION 882.5894	882.5894 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
21:8.0.1.1.28.5.1.37	SECTION 882.5895	882.5895 Vibratory counter-stimulation device.
21:8.0.1.1.28.5.1.38	SECTION 882.5896	882.5896 Percutaneous nerve stimulator for substance use disorders.
21:8.0.1.1.28.5.1.39	SECTION 882.5900	882.5900 Preformed craniosynostosis strip.
21:8.0.1.1.28.5.1.40	SECTION 882.5897	882.5897 External upper limb tremor stimulator.
21:8.0.1.1.28.5.1.41	SECTION 882.5910	882.5910 Dura substitute.
21:8.0.1.1.28.5.1.42	SECTION 882.5940	882.5940 Electroconvulsive therapy device.
21:8.0.1.1.28.5.1.43	SECTION 882.5950	882.5950 Neurovascular embolization device.
21:8.0.1.1.28.5.1.44	SECTION 882.5960	882.5960 Skull tongs for traction.
21:8.0.1.1.28.5.1.45	SECTION 882.5970	882.5970 Cranial orthosis.
21:8.0.1.1.28.5.1.46	SECTION 882.5975	882.5975 Human dura mater.
21:8.0.1.1.29	PART 884	PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES
21:8.0.1.1.29.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.29.1.1.1	SECTION 884.1	884.1 Scope.
21:8.0.1.1.29.1.1.2	SECTION 884.3	884.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.29.1.1.3	SECTION 884.9	884.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.29.2	SUBPART B	Subpart B - Obstetrical and Gynecological Diagnostic Devices
21:8.0.1.1.29.2.1.1	SECTION 884.1040	884.1040 Viscometer for cervical mucus.
21:8.0.1.1.29.2.1.2	SECTION 884.1050	884.1050 Endocervical aspirator.
21:8.0.1.1.29.2.1.3	SECTION 884.1060	884.1060 Endometrial aspirator.
21:8.0.1.1.29.2.1.4	SECTION 884.1100	884.1100 Endometrial brush.
21:8.0.1.1.29.2.1.5	SECTION 884.1175	884.1175 Endometrial suction curette and accessories.
21:8.0.1.1.29.2.1.6	SECTION 884.1185	884.1185 Endometrial washer.
21:8.0.1.1.29.2.1.7	SECTION 884.1300	884.1300 Uterotubal carbon dioxide insufflator and accessories.
21:8.0.1.1.29.2.1.8	SECTION 884.1425	884.1425 Perineometer.
21:8.0.1.1.29.2.1.9	SECTION 884.1550	884.1550 Amniotic fluid sampler (amniocentesis tray).
21:8.0.1.1.29.2.1.10	SECTION 884.1560	884.1560 Fetal blood sampler.
21:8.0.1.1.29.2.1.11	SECTION 884.1600	884.1600 Transabdominal amnioscope (fetoscope) and accessories.
21:8.0.1.1.29.2.1.12	SECTION 884.1630	884.1630 Colposcope.
21:8.0.1.1.29.2.1.13	SECTION 884.1640	884.1640 Culdoscope and accessories.
21:8.0.1.1.29.2.1.14	SECTION 884.1660	884.1660 Transcervical endoscope (amnioscope) and accessories.
21:8.0.1.1.29.2.1.15	SECTION 884.1690	884.1690 Hysteroscope and accessories.
21:8.0.1.1.29.2.1.16	SECTION 884.1700	884.1700 Hysteroscopic insufflator.
21:8.0.1.1.29.2.1.17	SECTION 884.1710	884.1710 Closed loop hysteroscopic insufflator with cutter-coagulator.
21:8.0.1.1.29.2.1.18	SECTION 884.1720	884.1720 Gynecologic laparoscope and accessories.
21:8.0.1.1.29.2.1.19	SECTION 884.1730	884.1730 Laparoscopic insufflator.
21:8.0.1.1.29.3	SUBPART C	Subpart C - Obstetrical and Gynecological Monitoring Devices
21:8.0.1.1.29.3.1.1	SECTION 884.2050	884.2050 Obstetric data analyzer.
21:8.0.1.1.29.3.1.2	SECTION 884.2225	884.2225 Obstetric-gynecologic ultrasonic imager.
21:8.0.1.1.29.3.1.3	SECTION 884.2600	884.2600 Fetal cardiac monitor.
21:8.0.1.1.29.3.1.4	SECTION 884.2620	884.2620 Fetal electroencephalographic monitor.
21:8.0.1.1.29.3.1.5	SECTION 884.2640	884.2640 Fetal phonocardiographic monitor and accessories.
21:8.0.1.1.29.3.1.6	SECTION 884.2660	884.2660 Fetal ultrasonic monitor and accessories.
21:8.0.1.1.29.3.1.7	SECTION 884.2675	884.2675 Fetal scalp circular (spiral) electrode and applicator.
21:8.0.1.1.29.3.1.8	SECTION 884.2685	884.2685 Fetal scalp clip electrode and applicator.
21:8.0.1.1.29.3.1.9	SECTION 884.2700	884.2700 Intrauterine pressure monitor and accessories.
21:8.0.1.1.29.3.1.10	SECTION 884.2720	884.2720 External uterine contraction monitor and accessories.
21:8.0.1.1.29.3.1.11	SECTION 884.2730	884.2730 Home uterine activity monitor.
21:8.0.1.1.29.3.1.12	SECTION 884.2740	884.2740 Perinatal monitoring system and accessories.
21:8.0.1.1.29.3.1.13	SECTION 884.2800	884.2800 Computerized Labor Monitoring System.
21:8.0.1.1.29.3.1.14	SECTION 884.2900	884.2900 Fetal stethoscope.
21:8.0.1.1.29.3.1.15	SECTION 884.2960	884.2960 Obstetric ultrasonic transducer and accessories.
21:8.0.1.1.29.3.1.16	SECTION 884.2980	884.2980 Telethermographic system.
21:8.0.1.1.29.3.1.17	SECTION 884.2982	884.2982 Liquid crystal thermographic system.
21:8.0.1.1.29.3.1.18	SECTION 884.2990	884.2990 Breast lesion documentation system.
21:8.0.1.1.29.4	SUBPART D	Subpart D - Obstetrical and Gynecological Prosthetic Devices
21:8.0.1.1.29.4.1.1	SECTION 884.3200	884.3200 Cervical drain.
21:8.0.1.1.29.4.1.2	SECTION 884.3575	884.3575 Vaginal pessary.
21:8.0.1.1.29.4.1.3	SECTION 884.3650	884.3650 Fallopian tube prosthesis.
21:8.0.1.1.29.4.1.4	SECTION 884.3900	884.3900 Vaginal stent.
21:8.0.1.1.29.5	SUBPART E	Subpart E - Obstetrical and Gynecological Surgical Devices
21:8.0.1.1.29.5.1.1	SECTION 884.4050	884.4050 Gynecologic laparoscopic power morcellation containment system.
21:8.0.1.1.29.5.1.2	SECTION 884.4100	884.4100 Endoscopic electrocautery and accessories.
21:8.0.1.1.29.5.1.3	SECTION 884.4120	884.4120 Gynecologic electrocautery and accessories.
21:8.0.1.1.29.5.1.4	SECTION 884.4150	884.4150 Bipolar endoscopic coagulator-cutter and accessories.
21:8.0.1.1.29.5.1.5	SECTION 884.4160	884.4160 Unipolar endoscopic coagulator-cutter and accessories.
21:8.0.1.1.29.5.1.6	SECTION 884.4250	884.4250 Expandable cervical dilator.
21:8.0.1.1.29.5.1.7	SECTION 884.4260	884.4260 Hygroscopic Laminaria cervical dilator.
21:8.0.1.1.29.5.1.8	SECTION 884.4270	884.4270 Vibratory cervical dilators.
21:8.0.1.1.29.5.1.9	SECTION 884.4340	884.4340 Fetal vacuum extractor.
21:8.0.1.1.29.5.1.10	SECTION 884.4350	884.4350 Fetal head elevator.
21:8.0.1.1.29.5.1.11	SECTION 884.4400	884.4400 Obstetric forceps.
21:8.0.1.1.29.5.1.12	SECTION 884.4500	884.4500 Obstetric fetal destructive instrument.
21:8.0.1.1.29.5.1.13	SECTION 884.4520	884.4520 Obstetric-gynecologic general manual instrument.
21:8.0.1.1.29.5.1.14	SECTION 884.4530	884.4530 Obstetric-gynecologic specialized manual instrument.
21:8.0.1.1.29.5.1.15	SECTION 884.4550	884.4550 Gynecologic surgical laser.
21:8.0.1.1.29.5.1.16	SECTION 884.4900	884.4900 Obstetric table and accessories.
21:8.0.1.1.29.5.1.17	SECTION 884.4910	884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.
21:8.0.1.1.29.6	SUBPART F	Subpart F - Obstetrical and Gynecological Therapeutic Devices
21:8.0.1.1.29.6.1.1	SECTION 884.5050	884.5050 Metreurynter-balloon abortion system.
21:8.0.1.1.29.6.1.2	SECTION 884.5070	884.5070 Vacuum abortion system.
21:8.0.1.1.29.6.1.3	SECTION 884.5100	884.5100 Obstetric anesthesia set.
21:8.0.1.1.29.6.1.4	SECTION 884.5150	884.5150 Nonpowered breast pump.
21:8.0.1.1.29.6.1.5	SECTION 884.5160	884.5160 Powered breast pump.
21:8.0.1.1.29.6.1.6	SECTION 884.5200	884.5200 Hemorrhoid prevention pressure wedge.
21:8.0.1.1.29.6.1.7	SECTION 884.5210	884.5210 Pressure wedge for the reduction of cesarean delivery.
21:8.0.1.1.29.6.1.8	SECTION 884.5225	884.5225 Abdominal decompression chamber.
21:8.0.1.1.29.6.1.9	SECTION 884.5250	884.5250 Cervical cap.
21:8.0.1.1.29.6.1.10	SECTION 884.5300	884.5300 Condom.
21:8.0.1.1.29.6.1.11	SECTION 884.5310	884.5310 Condom with spermicidal lubricant.
21:8.0.1.1.29.6.1.12	SECTION 884.5320	884.5320 Glans sheath.
21:8.0.1.1.29.6.1.13	SECTION 884.5330	884.5330 Multiple-use female condom.
21:8.0.1.1.29.6.1.14	SECTION 884.5340	884.5340 Single-use internal condom.
21:8.0.1.1.29.6.1.15	SECTION 884.5350	884.5350 Contraceptive diaphragm and accessories.
21:8.0.1.1.29.6.1.16	SECTION 884.5360	884.5360 Contraceptive intrauterine device (IUD) and introducer.
21:8.0.1.1.29.6.1.17	SECTION 884.5370	884.5370 Software application for contraception.
21:8.0.1.1.29.6.1.18	SECTION 884.5380	884.5380 Contraceptive tubal occlusion device (TOD) and introducer.
21:8.0.1.1.29.6.1.19	SECTION 884.5390	884.5390 Perineal heater.
21:8.0.1.1.29.6.1.20	SECTION 884.5400	884.5400 Menstrual cup.
21:8.0.1.1.29.6.1.21	SECTION 884.5425	884.5425 Scented or scented deodorized menstrual pad.
21:8.0.1.1.29.6.1.22	SECTION 884.5435	884.5435 Unscented menstrual pad.
21:8.0.1.1.29.6.1.23	SECTION 884.5460	884.5460 Scented or scented deodorized menstrual tampon.
21:8.0.1.1.29.6.1.24	SECTION 884.5470	884.5470 Unscented menstrual tampon.
21:8.0.1.1.29.6.1.25	SECTION 884.5900	884.5900 Therapeutic vaginal douche apparatus.
21:8.0.1.1.29.6.1.26	SECTION 884.5920	884.5920 Vaginal insufflator.
21:8.0.1.1.29.6.1.27	SECTION 884.5940	884.5940 Powered vaginal muscle stimulator for therapeutic use.
21:8.0.1.1.29.6.1.28	SECTION 884.5960	884.5960 Genital vibrator for therapeutic use.
21:8.0.1.1.29.6.1.29	SECTION 884.5970	884.5970 Clitoral engorgement device.
21:8.0.1.1.29.6.1.30	SECTION 884.5980	884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
21:8.0.1.1.29.7	SUBPART G	Subpart G - Assisted Reproduction Devices
21:8.0.1.1.29.7.1.1	SECTION 884.6100	884.6100 Assisted reproduction needles.
21:8.0.1.1.29.7.1.2	SECTION 884.6110	884.6110 Assisted reproduction catheters.
21:8.0.1.1.29.7.1.3	SECTION 884.6120	884.6120 Assisted reproduction accessories.
21:8.0.1.1.29.7.1.4	SECTION 884.6130	884.6130 Assisted reproduction microtools.
21:8.0.1.1.29.7.1.5	SECTION 884.6140	884.6140 Assisted reproduction micropipette fabrication instruments.
21:8.0.1.1.29.7.1.6	SECTION 884.6150	884.6150 Assisted reproduction micromanipulators and microinjectors.
21:8.0.1.1.29.7.1.7	SECTION 884.6160	884.6160 Assisted reproduction labware.
21:8.0.1.1.29.7.1.8	SECTION 884.6165	884.6165 Intravaginal culture system.
21:8.0.1.1.29.7.1.9	SECTION 884.6170	884.6170 Assisted reproduction water and water purification systems.
21:8.0.1.1.29.7.1.10	SECTION 884.6180	884.6180 Reproductive media and supplements.
21:8.0.1.1.29.7.1.11	SECTION 884.6190	884.6190 Assisted reproductive microscopes and microscope accessories.
21:8.0.1.1.29.7.1.12	SECTION 884.6195	884.6195 Assisted Reproduction Embryo Image Assessment System.
21:8.0.1.1.29.7.1.13	SECTION 884.6200	884.6200 Assisted reproduction laser system.
21:8.0.1.1.30	PART 886	PART 886 - OPHTHALMIC DEVICES
21:8.0.1.1.30.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.30.1.1.1	SECTION 886.1	886.1 Scope.
21:8.0.1.1.30.1.1.2	SECTION 886.3	886.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.30.1.1.3	SECTION 886.9	886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.30.2	SUBPART B	Subpart B - Diagnostic Devices
21:8.0.1.1.30.2.1.1	SECTION 886.1040	886.1040 Ocular esthesiometer.
21:8.0.1.1.30.2.1.2	SECTION 886.1050	886.1050 Adaptometer (biophotometer).
21:8.0.1.1.30.2.1.3	SECTION 886.1070	886.1070 Anomaloscope.
21:8.0.1.1.30.2.1.4	SECTION 886.1090	886.1090 Haidinger brush.
21:8.0.1.1.30.2.1.5	SECTION 886.1120	886.1120 Ophthalmic camera.
21:8.0.1.1.30.2.1.6	SECTION 886.1140	886.1140 Ophthalmic chair.
21:8.0.1.1.30.2.1.7	SECTION 886.1150	886.1150 Visual acuity chart.
21:8.0.1.1.30.2.1.8	SECTION 886.1160	886.1160 Color vision plate illuminator.
21:8.0.1.1.30.2.1.9	SECTION 886.1170	886.1170 Color vision tester.
21:8.0.1.1.30.2.1.10	SECTION 886.1190	886.1190 Distometer.
21:8.0.1.1.30.2.1.11	SECTION 886.1200	886.1200 Optokinetic drum.
21:8.0.1.1.30.2.1.12	SECTION 886.1220	886.1220 Corneal electrode.
21:8.0.1.1.30.2.1.13	SECTION 886.1250	886.1250 Euthyscope.
21:8.0.1.1.30.2.1.14	SECTION 886.1270	886.1270 Exophthalmometer.
21:8.0.1.1.30.2.1.15	SECTION 886.1290	886.1290 Fixation device.
21:8.0.1.1.30.2.1.16	SECTION 886.1300	886.1300 Afterimage flasher.
21:8.0.1.1.30.2.1.17	SECTION 886.1320	886.1320 Fornixscope.
21:8.0.1.1.30.2.1.18	SECTION 886.1330	886.1330 Amsler grid.
21:8.0.1.1.30.2.1.19	SECTION 886.1340	886.1340 Haploscope.
21:8.0.1.1.30.2.1.20	SECTION 886.1342	886.1342 Strabismus detection device.
21:8.0.1.1.30.2.1.21	SECTION 886.1350	886.1350 Keratoscope.
21:8.0.1.1.30.2.1.22	SECTION 886.1360	886.1360 Visual field laser instrument.
21:8.0.1.1.30.2.1.23	SECTION 886.1375	886.1375 Bagolini lens.
21:8.0.1.1.30.2.1.24	SECTION 886.1380	886.1380 Diagnostic condensing lens.
21:8.0.1.1.30.2.1.25	SECTION 886.1385	886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
21:8.0.1.1.30.2.1.26	SECTION 886.1390	886.1390 Flexible diagnostic Fresnel lens.
21:8.0.1.1.30.2.1.27	SECTION 886.1395	886.1395 Diagnostic Hruby fundus lens.
21:8.0.1.1.30.2.1.28	SECTION 886.1400	886.1400 Maddox lens.
21:8.0.1.1.30.2.1.29	SECTION 886.1405	886.1405 Ophthalmic trial lens set.
21:8.0.1.1.30.2.1.30	SECTION 886.1410	886.1410 Ophthalmic trial lens clip.
21:8.0.1.1.30.2.1.31	SECTION 886.1415	886.1415 Ophthalmic trial lens frame.
21:8.0.1.1.30.2.1.32	SECTION 886.1420	886.1420 Ophthalmic lens gauge.
21:8.0.1.1.30.2.1.33	SECTION 886.1425	886.1425 Lens measuring instrument.
21:8.0.1.1.30.2.1.34	SECTION 886.1430	886.1430 Ophthalmic contact lens radius measuring device.
21:8.0.1.1.30.2.1.35	SECTION 886.1435	886.1435 Maxwell spot.
21:8.0.1.1.30.2.1.36	SECTION 886.1450	886.1450 Corneal radius measuring device.
21:8.0.1.1.30.2.1.37	SECTION 886.1460	886.1460 Stereopsis measuring instrument.
21:8.0.1.1.30.2.1.38	SECTION 886.1500	886.1500 Headband mirror.
21:8.0.1.1.30.2.1.39	SECTION 886.1510	886.1510 Eye movement monitor.
21:8.0.1.1.30.2.1.40	SECTION 886.1570	886.1570 Ophthalmoscope.
21:8.0.1.1.30.2.1.41	SECTION 886.1605	886.1605 Perimeter.
21:8.0.1.1.30.2.1.42	SECTION 886.1630	886.1630 AC-powered photostimulator.
21:8.0.1.1.30.2.1.43	SECTION 886.1640	886.1640 Ophthalmic preamplifier.
21:8.0.1.1.30.2.1.44	SECTION 886.1650	886.1650 Ophthalmic bar prism.
21:8.0.1.1.30.2.1.45	SECTION 886.1655	886.1655 Ophthalmic Fresnel prism.
21:8.0.1.1.30.2.1.46	SECTION 886.1660	886.1660 Gonioscopic prism.
21:8.0.1.1.30.2.1.47	SECTION 886.1665	886.1665 Ophthalmic rotary prism.
21:8.0.1.1.30.2.1.48	SECTION 886.1670	886.1670 Ophthalmic isotope uptake probe.
21:8.0.1.1.30.2.1.49	SECTION 886.1680	886.1680 Ophthalmic projector.
21:8.0.1.1.30.2.1.50	SECTION 886.1690	886.1690 Pupillograph.
21:8.0.1.1.30.2.1.51	SECTION 886.1700	886.1700 Pupillometer.
21:8.0.1.1.30.2.1.52	SECTION 886.1750	886.1750 Skiascopic rack.
21:8.0.1.1.30.2.1.53	SECTION 886.1760	886.1760 Ophthalmic refractometer.
21:8.0.1.1.30.2.1.54	SECTION 886.1770	886.1770 Manual refractor.
21:8.0.1.1.30.2.1.55	SECTION 886.1780	886.1780 Retinoscope.
21:8.0.1.1.30.2.1.56	SECTION 886.1790	886.1790 Nearpoint ruler.
21:8.0.1.1.30.2.1.57	SECTION 886.1800	886.1800 Schirmer strip.
21:8.0.1.1.30.2.1.58	SECTION 886.1810	886.1810 Tangent screen (campimeter).
21:8.0.1.1.30.2.1.59	SECTION 886.1840	886.1840 Simulatan (including crossed cylinder).
21:8.0.1.1.30.2.1.60	SECTION 886.1850	886.1850 AC-powered slitlamp biomicroscope.
21:8.0.1.1.30.2.1.61	SECTION 886.1860	886.1860 Ophthalmic instrument stand.
21:8.0.1.1.30.2.1.62	SECTION 886.1870	886.1870 Stereoscope.
21:8.0.1.1.30.2.1.63	SECTION 886.1880	886.1880 Fusion and stereoscopic target.
21:8.0.1.1.30.2.1.64	SECTION 886.1905	886.1905 Nystagmus tape.
21:8.0.1.1.30.2.1.65	SECTION 886.1910	886.1910 Spectacle dissociation test system.
21:8.0.1.1.30.2.1.66	SECTION 886.1925	886.1925 Diurnal pattern recorder system.
21:8.0.1.1.30.2.1.67	SECTION 886.1930	886.1930 Tonometer and accessories.
21:8.0.1.1.30.2.1.68	SECTION 886.1940	886.1940 Tonometer sterilizer.
21:8.0.1.1.30.2.1.69	SECTION 886.1945	886.1945 Transilluminator.
21:8.0.1.1.30.3	SUBPART C	Subpart C [Reserved]
21:8.0.1.1.30.4	SUBPART D	Subpart D - Prosthetic Devices
21:8.0.1.1.30.4.1.1	SECTION 886.3100	886.3100 Ophthalmic tantalum clip.
21:8.0.1.1.30.4.1.2	SECTION 886.3130	886.3130 Ophthalmic conformer.
21:8.0.1.1.30.4.1.3	SECTION 886.3200	886.3200 Artificial eye.
21:8.0.1.1.30.4.1.4	SECTION 886.3300	886.3300 Absorbable implant (scleral buckling method).
21:8.0.1.1.30.4.1.5	SECTION 886.3320	886.3320 Eye sphere implant.
21:8.0.1.1.30.4.1.6	SECTION 886.3340	886.3340 Extraocular orbital implant.
21:8.0.1.1.30.4.1.7	SECTION 886.3400	886.3400 Keratoprosthesis.
21:8.0.1.1.30.4.1.8	SECTION 886.3600	886.3600 Intraocular lens.
21:8.0.1.1.30.4.1.9	SECTION 886.3800	886.3800 Scleral shell.
21:8.0.1.1.30.4.1.10	SECTION 886.3920	886.3920 Aqueous shunt.
21:8.0.1.1.30.5	SUBPART E	Subpart E - Surgical Devices
21:8.0.1.1.30.5.1.1	SECTION 886.4070	886.4070 Powered corneal burr.
21:8.0.1.1.30.5.1.2	SECTION 886.4100	886.4100 Radiofrequency electrosurgical cautery apparatus.
21:8.0.1.1.30.5.1.3	SECTION 886.4115	886.4115 Thermal cautery unit.
21:8.0.1.1.30.5.1.4	SECTION 886.4150	886.4150 Vitreous aspiration and cutting instrument.
21:8.0.1.1.30.5.1.5	SECTION 886.4155	886.4155 Scleral plug.
21:8.0.1.1.30.5.1.6	SECTION 886.4170	886.4170 Cryophthalmic unit.
21:8.0.1.1.30.5.1.7	SECTION 886.4230	886.4230 Ophthalmic knife test drum.
21:8.0.1.1.30.5.1.8	SECTION 886.4250	886.4250 Ophthalmic electrolysis unit.
21:8.0.1.1.30.5.1.9	SECTION 886.4270	886.4270 Intraocular gas.
21:8.0.1.1.30.5.1.10	SECTION 886.4275	886.4275 Intraocular fluid.
21:8.0.1.1.30.5.1.11	SECTION 886.4280	886.4280 Intraocular pressure measuring device.
21:8.0.1.1.30.5.1.12	SECTION 886.4300	886.4300 Intraocular lens guide.
21:8.0.1.1.30.5.1.13	SECTION 886.4335	886.4335 Operating headlamp.
21:8.0.1.1.30.5.1.14	SECTION 886.4350	886.4350 Manual ophthalmic surgical instrument.
21:8.0.1.1.30.5.1.15	SECTION 886.4355	886.4355 Corneal inlay inserter handle.
21:8.0.1.1.30.5.1.16	SECTION 886.4360	886.4360 Ocular surgery irrigation device.
21:8.0.1.1.30.5.1.17	SECTION 886.4370	886.4370 Keratome.
21:8.0.1.1.30.5.1.18	SECTION 886.4390	886.4390 Ophthalmic laser.
21:8.0.1.1.30.5.1.19	SECTION 886.4392	886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
21:8.0.1.1.30.5.1.20	SECTION 886.4400	886.4400 Electronic metal locator.
21:8.0.1.1.30.5.1.21	SECTION 886.4440	886.4440 AC-powered magnet.
21:8.0.1.1.30.5.1.22	SECTION 886.4445	886.4445 Permanent magnet.
21:8.0.1.1.30.5.1.23	SECTION 886.4570	886.4570 Ophthalmic surgical marker.
21:8.0.1.1.30.5.1.24	SECTION 886.4610	886.4610 Ocular pressure applicator.
21:8.0.1.1.30.5.1.25	SECTION 886.4670	886.4670 Phacofragmentation system.
21:8.0.1.1.30.5.1.26	SECTION 886.4690	886.4690 Ophthalmic photocoagulator.
21:8.0.1.1.30.5.1.27	SECTION 886.4750	886.4750 Ophthalmic eye shield.
21:8.0.1.1.30.5.1.28	SECTION 886.4770	886.4770 Ophthalmic operating spectacles (loupes).
21:8.0.1.1.30.5.1.29	SECTION 886.4790	886.4790 Ophthalmic sponge.
21:8.0.1.1.30.5.1.30	SECTION 886.4855	886.4855 Ophthalmic instrument table.
21:8.0.1.1.30.6	SUBPART F	Subpart F - Therapeutic Devices
21:8.0.1.1.30.6.1.1	SECTION 886.5100	886.5100 Ophthalmic beta radiation source.
21:8.0.1.1.30.6.1.2	SECTION 886.5120	886.5120 Low-power binocular loupe.
21:8.0.1.1.30.6.1.3	SECTION 886.5200	886.5200 Eyelid thermal pulsation system.
21:8.0.1.1.30.6.1.4	SECTION 886.5300	886.5300 Tear electrostimulation device.
21:8.0.1.1.30.6.1.5	SECTION 886.5310	886.5310 Intranasal electrostimulation device for dry eye symptoms.
21:8.0.1.1.30.6.1.6	SECTION 886.5420	886.5420 Contact lens inserter/remover.
21:8.0.1.1.30.6.1.7	SECTION 886.5540	886.5540 Low-vision magnifier.
21:8.0.1.1.30.6.1.8	SECTION 886.5600	886.5600 Ptosis crutch.
21:8.0.1.1.30.6.1.9	SECTION 886.5700	886.5700 Eyelid weight.
21:8.0.1.1.30.6.1.10	SECTION 886.5800	886.5800 Ophthalmic bar reader.
21:8.0.1.1.30.6.1.11	SECTION 886.5810	886.5810 Ophthalmic prism reader.
21:8.0.1.1.30.6.1.12	SECTION 886.5820	886.5820 Closed-circuit television reading system.
21:8.0.1.1.30.6.1.13	SECTION 886.5838	886.5838 Nasolacrimal compression device.
21:8.0.1.1.30.6.1.14	SECTION 886.5840	886.5840 Magnifying spectacles.
21:8.0.1.1.30.6.1.15	SECTION 886.5842	886.5842 Spectacle frame.
21:8.0.1.1.30.6.1.16	SECTION 886.5844	886.5844 Prescription spectacle lens.
21:8.0.1.1.30.6.1.17	SECTION 886.5850	886.5850 Sunglasses (nonprescription).
21:8.0.1.1.30.6.1.18	SECTION 886.5870	886.5870 Low-vision telescope.
21:8.0.1.1.30.6.1.19	SECTION 886.5900	886.5900 Electronic vision aid.
21:8.0.1.1.30.6.1.20	SECTION 886.5905	886.5905 Oral electronic vision aid.
21:8.0.1.1.30.6.1.21	SECTION 886.5910	886.5910 Image intensification vision aid.
21:8.0.1.1.30.6.1.22	SECTION 886.5915	886.5915 Optical vision aid.
21:8.0.1.1.30.6.1.23	SECTION 886.5916	886.5916 Rigid gas permeable contact lens.
21:8.0.1.1.30.6.1.24	SECTION 886.5918	886.5918 Rigid gas permeable contact lens care products.
21:8.0.1.1.30.6.1.25	SECTION 886.5925	886.5925 Soft (hydrophilic) contact lens.
21:8.0.1.1.30.6.1.26	SECTION 886.5928	886.5928 Soft (hydrophilic) contact lens care products.
21:8.0.1.1.30.6.1.27	SECTION 886.5933	886.5933 [Reserved]
21:8.0.1.1.31	PART 888	PART 888 - ORTHOPEDIC DEVICES
21:8.0.1.1.31.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.31.1.1.1	SECTION 888.1	888.1 Scope.
21:8.0.1.1.31.1.1.2	SECTION 888.3	888.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.31.1.1.3	SECTION 888.5	888.5 Resurfacing technique.
21:8.0.1.1.31.1.1.4	SECTION 888.6	888.6 Degree of constraint.
21:8.0.1.1.31.1.1.5	SECTION 888.9	888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.31.2	SUBPART B	Subpart B - Diagnostic Devices
21:8.0.1.1.31.2.1.1	SECTION 888.1100	888.1100 Arthroscope.
21:8.0.1.1.31.2.1.2	SECTION 888.1240	888.1240 AC-powered dynamometer.
21:8.0.1.1.31.2.1.3	SECTION 888.1250	888.1250 Nonpowered dynamometer.
21:8.0.1.1.31.2.1.4	SECTION 888.1500	888.1500 Goniometer.
21:8.0.1.1.31.2.1.5	SECTION 888.1520	888.1520 Nonpowered goniometer.
21:8.0.1.1.31.3	SUBPART C	Subpart C [Reserved]
21:8.0.1.1.31.4	SUBPART D	Subpart D - Prosthetic Devices
21:8.0.1.1.31.4.1.1	SECTION 888.3000	888.3000 Bone cap.
21:8.0.1.1.31.4.1.2	SECTION 888.3010	888.3010 Bone fixation cerclage.
21:8.0.1.1.31.4.1.3	SECTION 888.3015	888.3015 Bone heterograft.
21:8.0.1.1.31.4.1.4	SECTION 888.3020	888.3020 Intramedullary fixation rod.
21:8.0.1.1.31.4.1.5	SECTION 888.3023	888.3023 In vivo cured intramedullary fixation rod.
21:8.0.1.1.31.4.1.6	SECTION 888.3025	888.3025 Passive tendon prosthesis.
21:8.0.1.1.31.4.1.7	SECTION 888.3027	888.3027 Polymethylmethacrylate (PMMA) bone cement.
21:8.0.1.1.31.4.1.8	SECTION 888.3030	888.3030 Single/multiple component metallic bone fixation appliances and accessories.
21:8.0.1.1.31.4.1.9	SECTION 888.3040	888.3040 Smooth or threaded metallic bone fixation fastener.
21:8.0.1.1.31.4.1.10	SECTION 888.3045	888.3045 Resorbable calcium salt bone void filler device.
21:8.0.1.1.31.4.1.11	SECTION 888.3050	888.3050 Spinal interlaminal fixation orthosis.
21:8.0.1.1.31.4.1.12	SECTION 888.3060	888.3060 Spinal intervertebral body fixation orthosis.
21:8.0.1.1.31.4.1.13	SECTION 888.3070	888.3070 Thoracolumbosacral pedicle screw system.
21:8.0.1.1.31.4.1.14	SECTION 888.3075	888.3075 Posterior cervical screw system.
21:8.0.1.1.31.4.1.15	SECTION 888.3080	888.3080 Intervertebral body fusion device.
21:8.0.1.1.31.4.1.16	SECTION 888.3100	888.3100 Ankle joint metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.17	SECTION 888.3110	888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.18	SECTION 888.3120	888.3120 Ankle joint metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.19	SECTION 888.3150	888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.20	SECTION 888.3160	888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.21	SECTION 888.3170	888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
21:8.0.1.1.31.4.1.22	SECTION 888.3180	888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.23	SECTION 888.3200	888.3200 Finger joint metal/metal constrained uncemented prosthesis.
21:8.0.1.1.31.4.1.24	SECTION 888.3210	888.3210 Finger joint metal/metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.25	SECTION 888.3220	888.3220 Finger joint metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.26	SECTION 888.3230	888.3230 Finger joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.27	SECTION 888.3300	888.3300 Hip joint metal constrained cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.28	SECTION 888.3310	888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.29	SECTION 888.3320	888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
21:8.0.1.1.31.4.1.30	SECTION 888.3330	888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
21:8.0.1.1.31.4.1.31	SECTION 888.3340	888.3340 Hip joint metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.32	SECTION 888.3350	888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.33	SECTION 888.3353	888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
21:8.0.1.1.31.4.1.34	SECTION 888.3358	888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.35	SECTION 888.3360	888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.36	SECTION 888.3370	888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis.
21:8.0.1.1.31.4.1.37	SECTION 888.3380	888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
21:8.0.1.1.31.4.1.38	SECTION 888.3390	888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.39	SECTION 888.3400	888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
21:8.0.1.1.31.4.1.40	SECTION 888.3410	888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
21:8.0.1.1.31.4.1.41	SECTION 888.3480	888.3480 Knee joint femorotibial metallic constrained cemented prosthesis.
21:8.0.1.1.31.4.1.42	SECTION 888.3490	888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.43	SECTION 888.3500	888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.44	SECTION 888.3510	888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.45	SECTION 888.3520	888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.46	SECTION 888.3530	888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.47	SECTION 888.3535	888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.48	SECTION 888.3540	888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.49	SECTION 888.3550	888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.50	SECTION 888.3560	888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.51	SECTION 888.3565	888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.52	SECTION 888.3570	888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.53	SECTION 888.3580	888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
21:8.0.1.1.31.4.1.54	SECTION 888.3590	888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
21:8.0.1.1.31.4.1.55	SECTION 888.3640	888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.56	SECTION 888.3650	888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.57	SECTION 888.3660	888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.58	SECTION 888.3670	888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.59	SECTION 888.3680	888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
21:8.0.1.1.31.4.1.60	SECTION 888.3690	888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.61	SECTION 888.3720	888.3720 Toe joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.62	SECTION 888.3730	888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
21:8.0.1.1.31.4.1.63	SECTION 888.3750	888.3750 Wrist joint carpal lunate polymer prosthesis.
21:8.0.1.1.31.4.1.64	SECTION 888.3760	888.3760 Wrist joint carpal scaphoid polymer prosthesis.
21:8.0.1.1.31.4.1.65	SECTION 888.3770	888.3770 Wrist joint carpal trapezium polymer prosthesis.
21:8.0.1.1.31.4.1.66	SECTION 888.3780	888.3780 Wrist joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.67	SECTION 888.3790	888.3790 Wrist joint metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.68	SECTION 888.3800	888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.69	SECTION 888.3810	888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
21:8.0.1.1.31.5	SUBPART E	Subpart E - Surgical Devices
21:8.0.1.1.31.5.1.1	SECTION 888.4150	888.4150 Calipers for clinical use.
21:8.0.1.1.31.5.1.2	SECTION 888.4200	888.4200 Cement dispenser.
21:8.0.1.1.31.5.1.3	SECTION 888.4210	888.4210 Cement mixer for clinical use.
21:8.0.1.1.31.5.1.4	SECTION 888.4220	888.4220 Cement monomer vapor evacuator.
21:8.0.1.1.31.5.1.5	SECTION 888.4230	888.4230 Cement ventilation tube.
21:8.0.1.1.31.5.1.6	SECTION 888.4300	888.4300 Depth gauge for clinical use.
21:8.0.1.1.31.5.1.7	SECTION 888.4505	888.4505 Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.
21:8.0.1.1.31.5.1.8	SECTION 888.4540	888.4540 Orthopedic manual surgical instrument.
21:8.0.1.1.31.5.1.9	SECTION 888.4580	888.4580 Sonic surgical instrument and accessories/attachments.
21:8.0.1.1.31.5.1.10	SECTION 888.4600	888.4600 Protractor for clinical use.
21:8.0.1.1.31.5.1.11	SECTION 888.4800	888.4800 Template for clinical use.
21:8.0.1.1.31.5.1.12	SECTION 888.5850	888.5850 Nonpowered orthopedic traction apparatus and accessories.
21:8.0.1.1.31.5.1.13	SECTION 888.5890	888.5890 Noninvasive traction component.
21:8.0.1.1.31.5.1.14	SECTION 888.5940	888.5940 Cast component.
21:8.0.1.1.31.5.1.15	SECTION 888.5960	888.5960 Cast removal instrument.
21:8.0.1.1.31.5.1.16	SECTION 888.5980	888.5980 Manual cast application and removal instrument.
21:8.0.1.1.32	PART 890	PART 890 - PHYSICAL MEDICINE DEVICES
21:8.0.1.1.32.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.32.1.1.1	SECTION 890.1	890.1 Scope.
21:8.0.1.1.32.1.1.2	SECTION 890.3	890.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.32.1.1.3	SECTION 890.9	890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.32.2	SUBPART B	Subpart B - Physical Medicine Diagnostic Devices
21:8.0.1.1.32.2.1.1	SECTION 890.1175	890.1175 Electrode cable.
21:8.0.1.1.32.2.1.2	SECTION 890.1225	890.1225 Chronaximeter.
21:8.0.1.1.32.2.1.3	SECTION 890.1375	890.1375 Diagnostic electromyograph.
21:8.0.1.1.32.2.1.4	SECTION 890.1385	890.1385 Diagnostic electromyograph needle electrode.
21:8.0.1.1.32.2.1.5	SECTION 890.1450	890.1450 Powered reflex hammer.
21:8.0.1.1.32.2.1.6	SECTION 890.1575	890.1575 Force-measuring platform.
21:8.0.1.1.32.2.1.7	SECTION 890.1600	890.1600 Intermittent pressure measurement system.
21:8.0.1.1.32.2.1.8	SECTION 890.1615	890.1615 Miniature pressure transducer.
21:8.0.1.1.32.2.1.9	SECTION 890.1850	890.1850 Diagnostic muscle stimulator.
21:8.0.1.1.32.2.1.10	SECTION 890.1925	890.1925 Isokinetic testing and evaluation system.
21:8.0.1.1.32.3	SUBPART C	Subpart C [Reserved]
21:8.0.1.1.32.4	SUBPART D	Subpart D - Physical Medicine Prosthetic Devices
21:8.0.1.1.32.4.1.1	SECTION 890.3025	890.3025 Prosthetic and orthotic accessory.
21:8.0.1.1.32.4.1.2	SECTION 890.3075	890.3075 Cane.
21:8.0.1.1.32.4.1.3	SECTION 890.3100	890.3100 Mechanical chair.
21:8.0.1.1.32.4.1.4	SECTION 890.3110	890.3110 Electric positioning chair.
21:8.0.1.1.32.4.1.5	SECTION 890.3150	890.3150 Crutch.
21:8.0.1.1.32.4.1.6	SECTION 890.3175	890.3175 Flotation cushion.
21:8.0.1.1.32.4.1.7	SECTION 890.3410	890.3410 External limb orthotic component.
21:8.0.1.1.32.4.1.8	SECTION 890.3420	890.3420 External limb prosthetic component.
21:8.0.1.1.32.4.1.9	SECTION 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.
21:8.0.1.1.32.4.1.10	SECTION 890.3475	890.3475 Limb orthosis.
21:8.0.1.1.32.4.1.11	SECTION 890.3480	890.3480 Powered lower extremity exoskeleton.
21:8.0.1.1.32.4.1.12	SECTION 890.3490	890.3490 Truncal orthosis.
21:8.0.1.1.32.4.1.13	SECTION 890.3500	890.3500 External assembled lower limb prosthesis.
21:8.0.1.1.32.4.1.14	SECTION 890.3520	890.3520 Plinth.
21:8.0.1.1.32.4.1.15	SECTION 890.3610	890.3610 Rigid pneumatic structure orthosis.
21:8.0.1.1.32.4.1.16	SECTION 890.3640	890.3640 Arm sling.
21:8.0.1.1.32.4.1.17	SECTION 890.3665	890.3665 Congenital hip dislocation abduction splint.
21:8.0.1.1.32.4.1.18	SECTION 890.3675	890.3675 Denis Brown splint.
21:8.0.1.1.32.4.1.19	SECTION 890.3690	890.3690 Powered wheeled stretcher.
21:8.0.1.1.32.4.1.20	SECTION 890.3700	890.3700 Nonpowered communication system.
21:8.0.1.1.32.4.1.21	SECTION 890.3710	890.3710 Powered communication system.
21:8.0.1.1.32.4.1.22	SECTION 890.3725	890.3725 Powered environmental control system.
21:8.0.1.1.32.4.1.23	SECTION 890.3750	890.3750 Mechanical table.
21:8.0.1.1.32.4.1.24	SECTION 890.3760	890.3760 Powered table.
21:8.0.1.1.32.4.1.25	SECTION 890.3790	890.3790 Cane, crutch, and walker tips and pads.
21:8.0.1.1.32.4.1.26	SECTION 890.3800	890.3800 Motorized three-wheeled vehicle.
21:8.0.1.1.32.4.1.27	SECTION 890.3825	890.3825 Mechanical walker.
21:8.0.1.1.32.4.1.28	SECTION 890.3850	890.3850 Mechanical wheelchair.
21:8.0.1.1.32.4.1.29	SECTION 890.3860	890.3860 Powered wheelchair.
21:8.0.1.1.32.4.1.30	SECTION 890.3880	890.3880 Special grade wheelchair.
21:8.0.1.1.32.4.1.31	SECTION 890.3890	890.3890 Stair-climbing wheelchair.
21:8.0.1.1.32.4.1.32	SECTION 890.3900	890.3900 Standup wheelchair.
21:8.0.1.1.32.4.1.33	SECTION 890.3910	890.3910 Wheelchair accessory.
21:8.0.1.1.32.4.1.34	SECTION 890.3920	890.3920 Wheelchair component.
21:8.0.1.1.32.4.1.35	SECTION 890.3930	890.3930 Wheelchair elevator.
21:8.0.1.1.32.4.1.36	SECTION 890.3940	890.3940 Wheelchair platform scale.
21:8.0.1.1.32.5	SUBPART E	Subpart E [Reserved]
21:8.0.1.1.32.6	SUBPART F	Subpart F - Physical Medicine Therapeutic Devices
21:8.0.1.1.32.6.1.1	SECTION 890.5050	890.5050 Daily activity assist device.
21:8.0.1.1.32.6.1.2	SECTION 890.5100	890.5100 Immersion hydrobath.
21:8.0.1.1.32.6.1.3	SECTION 890.5110	890.5110 Paraffin bath.
21:8.0.1.1.32.6.1.4	SECTION 890.5125	890.5125 Nonpowered sitz bath.
21:8.0.1.1.32.6.1.5	SECTION 890.5150	890.5150 Powered patient transport.
21:8.0.1.1.32.6.1.6	SECTION 890.5160	890.5160 Air-fluidized bed.
21:8.0.1.1.32.6.1.7	SECTION 890.5170	890.5170 Powered flotation therapy bed.
21:8.0.1.1.32.6.1.8	SECTION 890.5180	890.5180 Manual patient rotation bed.
21:8.0.1.1.32.6.1.9	SECTION 890.5225	890.5225 Powered patient rotation bed.
21:8.0.1.1.32.6.1.10	SECTION 890.5250	890.5250 Moist steam cabinet.
21:8.0.1.1.32.6.1.11	SECTION 890.5275	890.5275 Microwave diathermy.
21:8.0.1.1.32.6.1.12	SECTION 890.5290	890.5290 Shortwave diathermy.
21:8.0.1.1.32.6.1.13	SECTION 890.5300	890.5300 Ultrasonic diathermy.
21:8.0.1.1.32.6.1.14	SECTION 890.5350	890.5350 Exercise component.
21:8.0.1.1.32.6.1.15	SECTION 890.5360	890.5360 Measuring exercise equipment.
21:8.0.1.1.32.6.1.16	SECTION 890.5370	890.5370 Nonmeasuring exercise equipment.
21:8.0.1.1.32.6.1.17	SECTION 890.5380	890.5380 Powered exercise equipment.
21:8.0.1.1.32.6.1.18	SECTION 890.5410	890.5410 Powered finger exerciser.
21:8.0.1.1.32.6.1.19	SECTION 890.5500	890.5500 Infrared lamp.
21:8.0.1.1.32.6.1.20	SECTION 890.5525	890.5525 Iontophoresis device.
21:8.0.1.1.32.6.1.21	SECTION 890.5575	890.5575 Powered external limb overload warning device.
21:8.0.1.1.32.6.1.22	SECTION 890.5650	890.5650 Powered inflatable tube massager.
21:8.0.1.1.32.6.1.23	SECTION 890.5660	890.5660 Therapeutic massager.
21:8.0.1.1.32.6.1.24	SECTION 890.5670	890.5670 Internal therapeutic massager.
21:8.0.1.1.32.6.1.25	SECTION 890.5700	890.5700 Cold pack.
21:8.0.1.1.32.6.1.26	SECTION 890.5710	890.5710 Hot or cold disposable pack.
21:8.0.1.1.32.6.1.27	SECTION 890.5720	890.5720 Water circulating hot or cold pack.
21:8.0.1.1.32.6.1.28	SECTION 890.5730	890.5730 Moist heat pack.
21:8.0.1.1.32.6.1.29	SECTION 890.5740	890.5740 Powered heating pad.
21:8.0.1.1.32.6.1.30	SECTION 890.5760	890.5760 Nonpowered lower extremity pressure wrap.
21:8.0.1.1.32.6.1.31	SECTION 890.5765	890.5765 Pressure-applying device.
21:8.0.1.1.32.6.1.32	SECTION 890.5850	890.5850 Powered muscle stimulator.
21:8.0.1.1.32.6.1.33	SECTION 890.5860	890.5860 Ultrasound and muscle stimulator.
21:8.0.1.1.32.6.1.34	SECTION 890.5880	890.5880 Multi-function physical therapy table.
21:8.0.1.1.32.6.1.35	SECTION 890.5900	890.5900 Power traction equipment.
21:8.0.1.1.32.6.1.36	SECTION 890.5925	890.5925 Traction accessory.
21:8.0.1.1.32.6.1.37	SECTION 890.5940	890.5940 Chilling unit.
21:8.0.1.1.32.6.1.38	SECTION 890.5950	890.5950 Powered heating unit.
21:8.0.1.1.32.6.1.39	SECTION 890.5975	890.5975 Therapeutic vibrator.
21:8.0.1.1.33	PART 892	PART 892 - RADIOLOGY DEVICES
21:8.0.1.1.33.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.33.1.1.1	SECTION 892.1	892.1 Scope.
21:8.0.1.1.33.1.1.2	SECTION 892.3	892.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.33.1.1.3	SECTION 892.9	892.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.33.2	SUBPART B	Subpart B - Diagnostic Devices
21:8.0.1.1.33.2.1.1	SECTION 892.1000	892.1000 Magnetic resonance diagnostic device.
21:8.0.1.1.33.2.1.2	SECTION 892.1100	892.1100 Scintillation (gamma) camera.
21:8.0.1.1.33.2.1.3	SECTION 892.1110	892.1110 Positron camera.
21:8.0.1.1.33.2.1.4	SECTION 892.1130	892.1130 Nuclear whole body counter.
21:8.0.1.1.33.2.1.5	SECTION 892.1170	892.1170 Bone densitometer.
21:8.0.1.1.33.2.1.6	SECTION 892.1180	892.1180 Bone sonometer.
21:8.0.1.1.33.2.1.7	SECTION 892.1200	892.1200 Emission computed tomography system.
21:8.0.1.1.33.2.1.8	SECTION 892.1220	892.1220 Fluorescent scanner.
21:8.0.1.1.33.2.1.9	SECTION 892.1300	892.1300 Nuclear rectilinear scanner.
21:8.0.1.1.33.2.1.10	SECTION 892.1310	892.1310 Nuclear tomography system.
21:8.0.1.1.33.2.1.11	SECTION 892.1320	892.1320 Nuclear uptake probe.
21:8.0.1.1.33.2.1.12	SECTION 892.1330	892.1330 Nuclear whole body scanner.
21:8.0.1.1.33.2.1.13	SECTION 892.1350	892.1350 Nuclear scanning bed.
21:8.0.1.1.33.2.1.14	SECTION 892.1360	892.1360 Radionuclide dose calibrator.
21:8.0.1.1.33.2.1.15	SECTION 892.1370	892.1370 Nuclear anthropomorphic phantom.
21:8.0.1.1.33.2.1.16	SECTION 892.1380	892.1380 Nuclear flood source phantom.
21:8.0.1.1.33.2.1.17	SECTION 892.1390	892.1390 Radionuclide rebreathing system.
21:8.0.1.1.33.2.1.18	SECTION 892.1400	892.1400 Nuclear sealed calibration source.
21:8.0.1.1.33.2.1.19	SECTION 892.1410	892.1410 Nuclear electrocardiograph synchronizer.
21:8.0.1.1.33.2.1.20	SECTION 892.1420	892.1420 Radionuclide test pattern phantom.
21:8.0.1.1.33.2.1.21	SECTION 892.1540	892.1540 Nonfetal ultrasonic monitor.
21:8.0.1.1.33.2.1.22	SECTION 892.1550	892.1550 Ultrasonic pulsed doppler imaging system.
21:8.0.1.1.33.2.1.23	SECTION 892.1560	892.1560 Ultrasonic pulsed echo imaging system.
21:8.0.1.1.33.2.1.24	SECTION 892.1570	892.1570 Diagnostic ultrasonic transducer.
21:8.0.1.1.33.2.1.25	SECTION 892.1600	892.1600 Angiographic x-ray system.
21:8.0.1.1.33.2.1.26	SECTION 892.1610	892.1610 Diagnostic x-ray beam-limiting device.
21:8.0.1.1.33.2.1.27	SECTION 892.1620	892.1620 Cine or spot fluorographic x-ray camera.
21:8.0.1.1.33.2.1.28	SECTION 892.1630	892.1630 Electrostatic x-ray imaging system.
21:8.0.1.1.33.2.1.29	SECTION 892.1640	892.1640 Radiographic film marking system.
21:8.0.1.1.33.2.1.30	SECTION 892.1650	892.1650 Image-intensified fluoroscopic x-ray system.
21:8.0.1.1.33.2.1.31	SECTION 892.1660	892.1660 Non-image-intensified fluoroscopic x-ray system.
21:8.0.1.1.33.2.1.32	SECTION 892.1670	892.1670 Spot-film device.
21:8.0.1.1.33.2.1.33	SECTION 892.1680	892.1680 Stationary x-ray system.
21:8.0.1.1.33.2.1.34	SECTION 892.1700	892.1700 Diagnostic x-ray high voltage generator.
21:8.0.1.1.33.2.1.35	SECTION 892.1710	892.1710 Mammographic x-ray system.
21:8.0.1.1.33.2.1.36	SECTION 892.1715	892.1715 Full-field digital mammography system.
21:8.0.1.1.33.2.1.37	SECTION 892.1720	892.1720 Mobile x-ray system.
21:8.0.1.1.33.2.1.38	SECTION 892.1730	892.1730 Photofluorographic x-ray system.
21:8.0.1.1.33.2.1.39	SECTION 892.1740	892.1740 Tomographic x-ray system.
21:8.0.1.1.33.2.1.40	SECTION 892.1750	892.1750 Computed tomography x-ray system.
21:8.0.1.1.33.2.1.41	SECTION 892.1760	892.1760 Diagnostic x-ray tube housing assembly.
21:8.0.1.1.33.2.1.42	SECTION 892.1770	892.1770 Diagnostic x-ray tube mount.
21:8.0.1.1.33.2.1.43	SECTION 892.1820	892.1820 Pneumoencephalographic chair.
21:8.0.1.1.33.2.1.44	SECTION 892.1830	892.1830 Radiologic patient cradle.
21:8.0.1.1.33.2.1.45	SECTION 892.1840	892.1840 Radiographic film.
21:8.0.1.1.33.2.1.46	SECTION 892.1850	892.1850 Radiographic film cassette.
21:8.0.1.1.33.2.1.47	SECTION 892.1860	892.1860 Radiographic film/cassette changer.
21:8.0.1.1.33.2.1.48	SECTION 892.1870	892.1870 Radiographic film/cassette changer programmer.
21:8.0.1.1.33.2.1.49	SECTION 892.1880	892.1880 Wall-mounted radiographic cassette holder.
21:8.0.1.1.33.2.1.50	SECTION 892.1890	892.1890 Radiographic film illuminator.
21:8.0.1.1.33.2.1.51	SECTION 892.1900	892.1900 Automatic radiographic film processor.
21:8.0.1.1.33.2.1.52	SECTION 892.1910	892.1910 Radiographic grid.
21:8.0.1.1.33.2.1.53	SECTION 892.1920	892.1920 Radiographic head holder.
21:8.0.1.1.33.2.1.54	SECTION 892.1940	892.1940 Radiologic quality assurance instrument.
21:8.0.1.1.33.2.1.55	SECTION 892.1950	892.1950 Radiographic anthropomorphic phantom.
21:8.0.1.1.33.2.1.56	SECTION 892.1960	892.1960 Radiographic intensifying screen.
21:8.0.1.1.33.2.1.57	SECTION 892.1970	892.1970 Radiographic ECG/respirator synchronizer.
21:8.0.1.1.33.2.1.58	SECTION 892.1980	892.1980 Radiologic table.
21:8.0.1.1.33.2.1.59	SECTION 892.1990	892.1990 Transilluminator for breast evaluation.
21:8.0.1.1.33.2.1.60	SECTION 892.2010	892.2010 Medical image storage device.
21:8.0.1.1.33.2.1.61	SECTION 892.2020	892.2020 Medical image communications device.
21:8.0.1.1.33.2.1.62	SECTION 892.2030	892.2030 Medical image digitizer.
21:8.0.1.1.33.2.1.63	SECTION 892.2040	892.2040 Medical image hardcopy device.
21:8.0.1.1.33.2.1.64	SECTION 892.2050	892.2050 Picture archiving and communications system.
21:8.0.1.1.33.2.1.65	SECTION 892.2060	892.2060 Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
21:8.0.1.1.33.2.1.66	SECTION 892.2070	892.2070 Medical image analyzer.
21:8.0.1.1.33.2.1.67	SECTION 892.2080	892.2080 Radiological computer aided triage and notification software.
21:8.0.1.1.33.3	SUBPART C	Subparts C-E [Reserved]
21:8.0.1.1.33.4	SUBPART F	Subpart F - Therapeutic Devices
21:8.0.1.1.33.4.1.1	SECTION 892.5050	892.5050 Medical charged-particle radiation therapy system.
21:8.0.1.1.33.4.1.2	SECTION 892.5300	892.5300 Medical neutron radiation therapy system.
21:8.0.1.1.33.4.1.3	SECTION 892.5650	892.5650 Manual radionuclide applicator system.
21:8.0.1.1.33.4.1.4	SECTION 892.5700	892.5700 Remote controlled radionuclide applicator system.
21:8.0.1.1.33.4.1.5	SECTION 892.5710	892.5710 Radiation therapy beam-shaping block.
21:8.0.1.1.33.4.1.6	SECTION 892.5720	892.5720 Rectal balloon for prostate immobilization.
21:8.0.1.1.33.4.1.7	SECTION 892.5725	892.5725 Absorbable perirectal spacer.
21:8.0.1.1.33.4.1.8	SECTION 892.5730	892.5730 Radionuclide brachytherapy source.
21:8.0.1.1.33.4.1.9	SECTION 892.5740	892.5740 Radionuclide teletherapy source.
21:8.0.1.1.33.4.1.10	SECTION 892.5750	892.5750 Radionuclide radiation therapy system.
21:8.0.1.1.33.4.1.11	SECTION 892.5770	892.5770 Powered radiation therapy patient support assembly.
21:8.0.1.1.33.4.1.12	SECTION 892.5780	892.5780 Light beam patient position indicator.
21:8.0.1.1.33.4.1.13	SECTION 892.5840	892.5840 Radiation therapy simulation system.
21:8.0.1.1.33.4.1.14	SECTION 892.5900	892.5900 X-ray radiation therapy system.
21:8.0.1.1.33.4.1.15	SECTION 892.5930	892.5930 Therapeutic x-ray tube housing assembly.
21:8.0.1.1.33.5	SUBPART G	Subpart G - Miscellaneous Devices
21:8.0.1.1.33.5.1.1	SECTION 892.6500	892.6500 Personnel protective shield.
21:8.0.1.1.34	PART 895	PART 895 - BANNED DEVICES
21:8.0.1.1.34.1	SUBPART A	Subpart A - General Provisions
21:8.0.1.1.34.1.1.1	SECTION 895.1	895.1 Scope.
21:8.0.1.1.34.1.1.2	SECTION 895.20	895.20 General.
21:8.0.1.1.34.1.1.3	SECTION 895.21	895.21 Procedures for banning a device.
21:8.0.1.1.34.1.1.4	SECTION 895.22	895.22 Submission of data and information by the manufacturer, distributor, or importer.
21:8.0.1.1.34.1.1.5	SECTION 895.25	895.25 Labeling.
21:8.0.1.1.34.1.1.6	SECTION 895.30	895.30 Special effective date.
21:8.0.1.1.34.2	SUBPART B	Subpart B - Listing of Banned Devices
21:8.0.1.1.34.2.1.1	SECTION 895.101	895.101 Prosthetic hair fibers.
21:8.0.1.1.34.2.1.2	SECTION 895.102	895.102 Powdered surgeon's glove.
21:8.0.1.1.34.2.1.3	SECTION 895.103	895.103 Powdered patient examination glove.
21:8.0.1.1.34.2.1.4	SECTION 895.104	895.104 Absorbable powder for lubricating a surgeon's glove.
21:8.0.1.1.34.2.1.5	SECTION 895.105	895.105 Electrical stimulation devices for self-injurious or aggressive behavior.
21:8.0.1.1.35	PART 898	PART 898 - PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
21:8.0.1.1.35.0.1.1	SECTION 898.11	898.11 Applicability.
21:8.0.1.1.35.0.1.2	SECTION 898.12	898.12 Performance standard.
21:8.0.1.1.35.0.1.3	SECTION 898.13	898.13 Compliance dates.
21:8.0.1.1.35.0.1.4	SECTION 898.14	898.14 Exemptions and variances.

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