What is 21 CFR 820?

21 CFR Part 820 is the Quality System Regulation (QSR) established by the U.S. Food and Drug Administration (FDA). It outlines the Current Good Manufacturing Practice (CGMP) requirements for medical device manufacturers. It dictates the methods, facilities, and controls used for designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. Compliance with 21 CFR Part 820 is mandatory for medical device companies that wish to market their products in the United States.