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.
- § 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.
- § 801.45— Devices that must be directly marked with a unique device identifier.
- § 801.50— Labeling requirements for stand-alone software.
- § 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
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.