QSR Changes Document Added to the Ombu Library

The Ombu Library has a new document, in the Medical Device Regulations section, that lists the changes to FDA’s Quality System Regulation. FDA issued the final rule on Oct. 7, 1996. Since then, QSR changed seven times. FDA has changed only three sections since they issued the final rule:

21 CFR §820.1 Scope

21 CFR §820.198 Complaint files

21 CFR §820.200 Servicing

The summary identifies the sections affected, lists the changes, and provides the citation in the Federal Register.