What is FDA / GMP?
The Good Manufacturing Practices (GMP) regulation, promulgated under section 520 of the Food, Drug and Cosmetic Act, requires that domestic or foreign manufacturers of medical devices intend for commercial distribution in the United States have a quality assurance (QA) program. The regulation requires that various specifications and controls be established for devices and that finished devices meet these specifications. Thus, the GMP regulation helps assure that medical devices are safe and effective for the intended use. The Food and Drug Administration (FDA) monitor device compliance with the QA program requirements in the regulation. Manufactures and importers of medical devices must also comply with the Medical Device Reporting (MDR) regulation, 21 CFR Part 803, which requires that serious complaints be reported to the FDA. The GMP regulations apply to the manufacture of finished devices intended to be commercially distributed for human use unless there is an approved exemption in
