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 CFR Part 801 · Labeling
§ 801.116 Medical devices having commonly known directions
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FDA guidance that cites § 801.116
Amendment history
Federal Register documents that created or amended this section.
- 41 FR 6896 13 Feb 1976