21 CFR 801.116
§ 801.116 Medical devices having commonly known directions.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 801.116, § 801.116 Medical devices having commonly known directions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88677
- Permanent ID
ys:prov:88677@1- SHA-256
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Full text
A device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.