Quality System Regulation (QSR) or FDA 21 CFR Part 820 defines Current Good Manufacturing Practice (cGMP) regulations. Established by FDA, 21 CFR Part 820 focuses on ensuring the products meet requirements and specifications consistently. These requirements focus on the safety and effectiveness of medical devices as directed by FDA. All medical device manufacturers are mandated to undergo FDA inspections as part of FDA 21 CFR 820 compliance requirement.