21 CFR Part 820

From Elsmar Cove Quality Assurance and Business Standards Wiki

21 CFR Part 820 - 21 CFR Part 820 is a set of regulatory standards laid out by the U.S. Food and Drug Administration for the purpose of ensuring the adequacy of quality systems involved in the manufacture of medical devices.

Drug products are regulated under 21 CFR Part 211.

Links to Forum Discussion Threads

Definition of Finished Medical Device - 21 CFR Part 820.1

21 CFR Part 820 discussion threads.

Medical device forum