Code of Federal Regulations · Section

§ 801.116 — Medical Devices Having Commonly Known Directions

21 C.F.R. § 801.116

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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. § 801.110 21 C.F.R. § 801.119

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