Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
All TitlesTitle 21Chapter IPart 801Subpart D - Subpart D—Exemptions From Adequate Directions for Use
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
cite as: 21 CFR 801.116
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