21 CFR PART 801 LABELING

Subpart A–General Labeling Provisions
§ 801.5 – Medical devices; adequate directions for use.
§ 801.6 – Medical devices; misleading statements.
§ 801.15 – Medical devices; prominence of required label statements.
§ 801.16 – Medical devices; Spanish-language version of certain required statements.
§ 801.1 – Medical devices; name and place of business of manufacturer, packer or distributor.
§ 801.4 – Meaning ofintended uses.

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Subpart B [Reserved]

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.
§ 801.420 – Hearing aid devices; professional and patient labeling.
§ 801.421 – Hearing aid devices; conditions for sale.
§ 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.

Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.
Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

Last Updated: 2015-07-26