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.

21:8.0.1.1.2.1SUBPART A
Subpart A - General Labeling Provisions
21:8.0.1.1.2.1.1.1SECTION 801.1
   801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
21:8.0.1.1.2.1.1.2SECTION 801.3
   801.3 Definitions.
21:8.0.1.1.2.1.1.3SECTION 801.4
   801.4 Meaning of intended uses.
21:8.0.1.1.2.1.1.5SECTION 801.5
   801.5 Medical devices; adequate directions for use.
21:8.0.1.1.2.1.1.6SECTION 801.6
   801.6 Medical devices; misleading statements.
21:8.0.1.1.2.1.1.7SECTION 801.15
   801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
21:8.0.1.1.2.1.1.8SECTION 801.16
   801.16 Medical devices; Spanish-language version of certain required statements.
21:8.0.1.1.2.1.1.9SECTION 801.18
   801.18 Format of dates provided on a medical device label.
21:8.0.1.1.2.2SUBPART B
Subpart B - Labeling Requirements for Unique Device Identification
21:8.0.1.1.2.2.1.1SECTION 801.20
   801.20 Label to bear a unique device identifier.
21:8.0.1.1.2.2.1.2SECTION 801.30
   801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
21:8.0.1.1.2.2.1.3SECTION 801.35
   801.35 Voluntary labeling of a device with a unique device identifier.
21:8.0.1.1.2.2.1.4SECTION 801.40
   801.40 Form of a unique device identifier.
21:8.0.1.1.2.2.1.5SECTION 801.45
   801.45 Devices that must be directly marked with a unique device identifier.
21:8.0.1.1.2.2.1.6SECTION 801.50
   801.50 Labeling requirements for stand-alone software.
21:8.0.1.1.2.2.1.7SECTION 801.55
   801.55 Request for an exception from or alternative to a unique device identifier requirement.
21:8.0.1.1.2.2.1.8SECTION 801.57
   801.57 Discontinuation of legacy FDA identification numbers assigned to devices.
21:8.0.1.1.2.3SUBPART C
Subpart C - Labeling Requirements for Over-the-Counter Devices
21:8.0.1.1.2.3.1.1SECTION 801.60
   801.60 Principal display panel.
21:8.0.1.1.2.3.1.2SECTION 801.61
   801.61 Statement of identity.
21:8.0.1.1.2.3.1.3SECTION 801.62
   801.62 Declaration of net quantity of contents.
21:8.0.1.1.2.3.1.4SECTION 801.63
   801.63 Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.
21:8.0.1.1.2.4SUBPART D
Subpart D - Exemptions From Adequate Directions for Use
21:8.0.1.1.2.4.1.1SECTION 801.109
   801.109 Prescription devices.
21:8.0.1.1.2.4.1.2SECTION 801.110
   801.110 Retail exemption for prescription devices.
21:8.0.1.1.2.4.1.3SECTION 801.116
   801.116 Medical devices having commonly known directions.
21:8.0.1.1.2.4.1.4SECTION 801.119
   801.119 In vitro diagnostic products.
21:8.0.1.1.2.4.1.5SECTION 801.122
   801.122 Medical devices for processing, repacking, or manufacturing.
21:8.0.1.1.2.4.1.6SECTION 801.125
   801.125 Medical devices for use in teaching, law enforcement, research, and analysis.
21:8.0.1.1.2.4.1.7SECTION 801.127
   801.127 Medical devices; expiration of exemptions.
21:8.0.1.1.2.4.1.8SECTION 801.128
   801.128 Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
21:8.0.1.1.2.5SUBPART E
Subpart E - Other Exemptions
21:8.0.1.1.2.5.1.1SECTION 801.150
   801.150 Medical devices; processing, labeling, or repacking.
21:8.0.1.1.2.6SUBPART F
Subparts F-G [Reserved]
21:8.0.1.1.2.7SUBPART H
Subpart H - Special Requirements for Specific Devices
21:8.0.1.1.2.7.1.1SECTION 801.405
   801.405 Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
21:8.0.1.1.2.7.1.2SECTION 801.410
   801.410 Use of impact-resistant lenses in eyeglasses and sunglasses.
21:8.0.1.1.2.7.1.3SECTION 801.415
   801.415 Maximum acceptable level of ozone.
21:8.0.1.1.2.7.1.4SECTION 801.417
   801.417 Chlorofluorocarbon propellants.
21:8.0.1.1.2.7.1.5SECTION 801.420
   801.420 Hearing aid devices; professional and patient labeling.
21:8.0.1.1.2.7.1.6SECTION 801.421
   801.421 Hearing aid devices; conditions for sale.
21:8.0.1.1.2.7.1.7SECTION 801.430
   801.430 User labeling for menstrual tampons.
21:8.0.1.1.2.7.1.8SECTION 801.433
   801.433 Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
21:8.0.1.1.2.7.1.9SECTION 801.435
   801.435 User labeling for latex condoms.
21:8.0.1.1.2.7.1.10SECTION 801.437
   801.437 User labeling for devices that contain natural rubber.