FDA 21 CFR Part 820 is the Quality System Regulation (QSR) enforced by the U.S. Food and Drug Administration (FDA) for medical device manufacturers. It outlines the Current Good Manufacturing Practice (CGMP) requirements for methods and facilities used in the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for human use. It ensures that medical devices are safe, effective, and meet applicable requirements.
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