The Quality System Regulation (QRS) criteria are in place to guarantee that medical devices are of high quality, safe, and effective. In addition, the current good manufacturing practice (CGMP) rules for producing medical devices are outlined in 21 CFR Part 820. It regulates the techniques, equipment, and controls used in the design, production, packing, labelling, storage, installation, and service of medical devices.
The first CGMP standards for medical devices were developed on July 21, 1978, and the regulation was codified under part 820 on December 18, 1978. The FDA began revising the CGMP in 1990 to include design controls.
The FDA 21 CFR 820 regulations apply to completed device manufacturers that sell commercial medical devices. A completed device is defined as “any device or accessory to any device that is acceptable for use or capable of functioning, regardless of whether it is packed, labelled, or sterilised,” according to 21 CFR 820.3(l).