21 CFR Part 801
PART 801—LABELING
- PART 801—LABELING
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- 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
- § 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
- § 801.150 Medical devices; processing, labeling, or repacking.
- Subparts F-G [Reserved]
- 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.
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