U.S. Food and Drug Administration
📍 Silver Spring, MDFounded 1906👥 10000+ employees🔒 Private
About
The U.S. Food and Drug Administration (FDA) is a federal regulatory agency responsible for protecting public health by ensuring the safety, efficacy, and security of medical devices, pharmaceuticals, and food products. In the robotics industry, the FDA plays a critical role in evaluating and clearing or approving surgical robots, rehabilitation devices, and other robotic medical technologies through pathways such as 510(k) premarket notification and premarket approval (PMA). FDA clearance is essential for companies seeking to commercialize medical robotics in the United States market.
Key Products
510(k) Premarket NotificationPremarket Approval (PMA)De Novo ClassificationBreakthrough Devices Program