Title 21

PART 801

Part 801 - Labeling

PART 801 - LABELING Authority:21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 374. Source:41 FR 6896, Feb. 13, 1976, unless otherwise noted.

• Authority: 21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 374.
• Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

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.

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