The Food and Drug Administration Medical Device Review Process

T he Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety and effectiveness of a variety of medical products, including drugs, devices, and biological products, and for advancing public health by helping to speed innovations that make treatments more effective, safer, and more affordable.The Center for Devices and Radiological Health (CDRH) in the FDA is responsible for premarket and postmarket regulation of medical devices.On August 11, 2004 the FDA gave market authorization to the first medical device specifically indicated to retrieve blood clots from the brain in ischemic stroke for patients who fail or are ineligible for intravenous tissue plasminogen activator (tPA).This article summarizes the FDA regulatory process for marketing medical devices in general and provides background on the FDA clearance of a clot retriever for ischemic stroke.