What 21 CFR Part 801 - Medical Device Labeling requires
21 CFR Part 801 sets out the FDA labeling requirements for medical devices. The label of a device in package form must conspicuously specify the name and place of business of the manufacturer, packer or distributor, qualified to reveal the connection where the named person is not the manufacturer. The labeling must bear adequate directions for use, meaning directions under which a layman can use the device safely for its intended uses, with intended use determined by the objective intent of the persons responsible for the labeling. Required label statements must appear with the prominence and conspicuousness required by section 502(c) of the Federal Food, Drug, and Cosmetic Act, and where dates are provided they must use the standardized year-month-day format. The label of every medical device, and every device package, must bear a unique device identifier (UDI) that meets the requirements of the subpart and of part 830, unless an exception applies. Prescription devices must be labeled in accordance with the prescription-device rules, including the limitation to use under the supervision of a licensed practitioner, and over-the-counter devices must bear the required statement of identity on the principal display panel. Devices that contain or come into contact with natural rubber latex must bear the required latex caution statement. Labeling that is false or misleading in any particular renders the device misbranded.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801
SHA-256 integrity: e7608d2bcb5701fc68db1074bd55876cbd19c27cd860565f62e79bdd07967646
Primary Citations — 8 traced to source
- 21 CFR Part 801, §801.1 - name and place of business of manufacturer, packer or distributor on the device label
- 21 CFR Part 801, §801.4 and §801.5 - meaning of intended uses and adequate directions for use
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