The U.S. FDA’s Center for Devices and Radiological Health (CDRH) assures that patients and health care providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH uses and applies postmarket surveillance to accurately characterize real-world performance of medical devices, identify poorly performing medical devices, and enhance CDRH’s regulatory decisions.
CDRH uses Sentinel as part of the assessment of postmarket safety of medical devices when applicable to complement CDRH’s other ongoing surveillance efforts. These surveillance efforts include the FDA’s Manufacturer and User Facility Device Experience (MAUDE), postmarket mandated studies (for example, post approval studies and 522 studies), and the National Evaluation System for health Technology (NEST). CDRH reviews the available data and balances the strengths and limitations of each data source to make the most informed regulatory decisions possible.
Visit FDA.gov for more information about CDRH.