Who does 21 CFR part 11 apply to? 1.28K viewsOctober 10, 2022FDA 0 Sam Smith11.38K March 12, 2021 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted March 15, 2021 0 Comments Spread the loveCoverage. Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions. Spread the love Login