§801.116. Medical devices having commonly known directions.
21 C.F.R. § 801.116
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374.
Source
Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.