21 C.F.R. § 801.116 Medical devices having commonly known directions.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 801—LABELING
Subpart D—Exemptions From Adequate Directions for Use
§ 801.116 Medical devices having commonly known directions.
