21 CFR 801.116 - Medical devices having commonly known directions.

Regulations last checked for updates: Feb 06, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart D [§ 801.109 - § 801.128]

§ 801.116 - Medical devices having commonly known directions.

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.

authority: 21 U.S.C. 321,331,351,352,360d,360i,360j,371,374

source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

cite as: 21 CFR 801.116