21 C.F.R. § 801.116

Medical devices having commonly known directions.

Last amended: 2016Year: 2026Length: 25 wordsOfficial source

Cite as 21 C.F.R. § 801.116 (2026)

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.
21 C.F.R. § 801.116: Medical devices having commonly known directions. | Justis AI