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FEDERAL · 21 CFR

Part 801 — Labeling

38 sections · Title 21: Food and Drugs

§ 801.1Medical devices; name and place of business of manufacturer, packer or distributor.
§ 801.3Definitions.
§ 801.4Meaning of intended uses.
§ 801.5Medical devices; adequate directions for use.
§ 801.6Medical devices; misleading statements.
§ 801.15Medical devices; prominence of required label statements; use of symbols in labeling.
§ 801.16Medical devices; Spanish-language version of certain required statements.
§ 801.18Format of dates provided on a medical device label.
§ 801.20Label to bear a unique device identifier.
§ 801.30General exceptions from the requirement for the label of a device to bear a unique device identifier.
§ 801.35Voluntary labeling of a device with a unique device identifier.
§ 801.40Form of a unique device identifier.
§ 801.45Devices that must be directly marked with a unique device identifier.
§ 801.50Labeling requirements for stand-alone software.
§ 801.55Request for an exception from or alternative to a unique device identifier requirement.
§ 801.57Discontinuation of legacy FDA identification numbers assigned to devices.
§ 801.60Principal display panel.
§ 801.61Statement of identity.
§ 801.62Declaration of net quantity of contents.
§ 801.63Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.
§ 801.109Prescription devices.
§ 801.110Retail exemption for prescription devices.
§ 801.116Medical devices having commonly known directions.
§ 801.119In vitro diagnostic products.
§ 801.122Medical devices for processing, repacking, or manufacturing.
§ 801.125Medical devices for use in teaching, law enforcement, research, and analysis.
§ 801.127Medical devices; expiration of exemptions.
§ 801.128Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.
§ 801.150Medical devices; processing, labeling, or repacking.
§ 801.405Labeling of articles intended for lay use in the repairing and/or refitting of dentures.
§ 801.410Use of impact-resistant lenses in eyeglasses and sunglasses.
§ 801.415Maximum acceptable level of ozone.
§ 801.417Chlorofluorocarbon propellants.
§ 801.422Prescription hearing aid labeling.
§ 801.430User labeling for menstrual tampons.
§ 801.433Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
§ 801.435User labeling for latex condoms.
§ 801.437User labeling for devices that contain natural rubber.