21 CFR Part 820

21 CFR Part 820 is a regulation set by the U.S. Food and Drug Administration (FDA) that establishes quality system requirements for medical device manufacturers. It ensures that devices are designed and produced in a consistent manner that meets safety and effectiveness standards. This part covers various aspects, including design control, document management, and supplier quality, to guarantee that medical devices are safe for use. Compliance with these regulations helps protect public health by ensuring that medical devices are reliable and meet established quality benchmarks before reaching consumers.