What is 21 CFR Part 820?

21 CFR Part 820 is the part of Title 21 of the Code of Federal Regulations that outlines the Quality System (QS) regulation for medical devices. It describes the Current Good Manufacturing Practice (CGMP) requirements used by the FDA to regulate medical device manufacturers. It covers aspects like management responsibility, design controls, purchasing controls, production and process controls, corrective and preventive action (CAPA), and record keeping to ensure devices are safe, effective, and meet their intended use.