FDA, short for Food and Drug Administration, an international medical evaluation authority, was empowered by the United States Congress (the federal government) to serve as the highest law enforcement agency engaged in the regulation of food, drugs, medical devices, electromagnetic radiation emitting devices (ERED), vaccines, blood and biological products, animal food & feeds and veterinary products, cosmetics and tobacco products.
FDA regulates medical devices through the Center for Devices and Radiological Health (CDRH), which supervises medical device manufacturers, packers and distributors to conduct business activities under the premise of abiding by laws. Medical devices, ranging in nature and complexity from simple medical gloves to complex pacemakers, are all under FDA supervision. FDA divides medical devices into classes I, II and III, taking into account the intended purpose of the devices and their inherent risks (the higher the classification, the stricter the regulation).
FDA (FY 2020)
FY 2020: from 1 October 2019 to 30 September 2020
FDA Official Timeframe (Day)
FDA De Novo Request
FDA 513(g) Request
FDA PMA (Premarket Approval)
FDA MD Pre-Submission
FDA Device Listing
FDA Establishment Registration and Device Listing (510(k) exempt)
U.S. Medical Device Agent