The regulatory agency responsible for FDA medical device registration in the United States is the U.S. Food and Drug Administration (FDA). The FDA is a federal agency within the Department of Health and Human Services (HHS) and is tasked with protecting public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation.

For medical devices, the FDA's Center for Devices and Radiological Health (CDRH) oversees regulatory activities. CDRH is responsible for evaluating and approving medical devices through a comprehensive review process that assesses safety, efficacy, and quality. This includes reviewing premarket submissions such as premarket notifications (510(k)), premarket approval applications (PMA), and De Novo classification requests.

FDA regulations, including the Quality System Regulation (QSR) under 21 CFR Part 820, outline requirements for medical device manufacturers to establish and maintain quality management systems, conduct risk management activities, and adhere to specific regulatory standards. The FDA also conducts inspections of manufacturing facilities and other establishments to ensure compliance with these regulations and to verify the safety and quality of marketed medical devices.

In summary, the FDA, specifically the Center for Devices and Radiological Health (CDRH), serves as the regulatory authority overseeing the approval and regulation of medical devices in the United States. Manufacturers seeking FDA registration must navigate these regulatory processes to obtain market clearance and ensure compliance with applicable FDA requirements.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn