§ 801.116. Medical devices having commonly known directions.
25 words·~1 min read·
/us/cfr/t21/s§ 801.116·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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.