What is 21CFR Part 820?

21 CFR Part 820 is the part of the Code of Federal Regulations (CFR) that outlines the Quality System Regulation (QSR) for medical devices. It describes the current good manufacturing practice (CGMP) requirements that manufacturers must follow to ensure that their devices consistently meet applicable requirements and specifications. It covers aspects like design controls, purchasing controls, production and process controls, acceptance activities, corrective and preventive actions (CAPA), and labeling/packaging controls. Compliance with 21 CFR Part 820 is essential for manufacturers to legally market their medical devices in the United States.