QSR 21CFR820

21 CFR 820 is applicable to manufacturers of finished medical devices sold in the United States, including imported products.

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for medical devices  became effective on December 18, 1978, and was codified under part 820 (21 CFR part 820).