21 CFR Part 820 - Quality System Regulation

FDA 21 CFR Part 820, is also known as the Quality System Regulation (QSR). The QSR provides an outline of the Current Good Manufacturing Practice CGMP regulations that administer the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices planned for human use. The purpose of these requirements is to ensure that medical devices are safe and effective. The FDA inspects Medical device manufacturers to ensure they are compliant with FDA 21 CFR Part 820.