21 CFR
Part 801 Labeling
Subpart A - General Labeling Provisions
- § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor
- § 801.3 Definitions
- § 801.4 Meaning of intended uses
- § 801.5 Medical devices; adequate directions for use
- § 801.6 Medical devices; misleading statements
- § 801.15 Medical devices; prominence of required label statements; use of symbols in labeling
- § 801.16 Medical devices; Spanish-language version of certain required statements
- § 801.18 Format of dates provided on a medical device label
Subpart B - Labeling Requirements for Unique Device Identification
- § 801.20 Label to bear a unique device identifier 126 × 483
- § 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier
- § 801.35 Voluntary labeling of a device with a unique device identifier
- § 801.40 Form of a unique device identifier 7 × 483
- § 801.45 Devices that must be directly marked with a unique device identifier 3 × 483
- § 801.50 Labeling requirements for stand-alone software 4 × 483
- § 801.55 Request for an exception from or alternative to a unique device identifier requirement
- § 801.57 Discontinuation of legacy FDA identification numbers assigned to devices
Subpart C - Labeling Requirements for Over-the-Counter Devices
- § 801.60 Principal display panel
- § 801.61 Statement of identity
- § 801.62 Declaration of net quantity of contents
- § 801.63 Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances
Subpart D - Exemptions From Adequate Directions for Use
- § 801.109 Prescription devices
- § 801.110 Retail exemption for prescription devices
- § 801.116 Medical devices having commonly known directions
- § 801.119 In vitro diagnostic products
- § 801.122 Medical devices for processing, repacking, or manufacturing
- § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis
- § 801.127 Medical devices; expiration of exemptions
- § 801.128 Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile
Subpart E - Other Exemptions
Subpart H - Special Requirements for Specific Devices
- § 801.405 Labeling of articles intended for lay use in the repairing and/or refitting of dentures
- § 801.410 Use of impact-resistant lenses in eyeglasses and sunglasses
- § 801.415 Maximum acceptable level of ozone
- § 801.417 Chlorofluorocarbon propellants
- § 801.422 Prescription hearing aid labeling
- § 801.430 User labeling for menstrual tampons
- § 801.433 Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances
- § 801.435 User labeling for latex condoms
- § 801.437 User labeling for devices that contain natural rubber