Part 820

Part 820 refers to the Quality System Regulation established by the FDA for medical device manufacturers. It sets requirements for designing, manufacturing, packaging, labeling, storing, and distributing medical devices to ensure they are safe and effective. The regulation covers processes like documenting procedures, controlling changes, handling complaints, and maintaining records. Compliance helps ensure that medical devices meet quality standards and regulatory expectations, ultimately protecting patients and healthcare professionals. In short, Part 820 is a set of rules that manufacturers follow to produce reliable and safe medical devices.