FDA 21 CFR Part 820 is the Quality System Regulation (QSR) that outlines current good manufacturing practice (CGMP) requirements for medical device manufacturers. It governs the methods, facilities, and controls used for designing, manufacturing, packaging, labeling, storing, installing, and servicing of finished 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, ensuring device safety and effectiveness.
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