What steps is FDA taking to strengthen the medical device post-market surveillance program?
FDA’s Center for Devices and Radiological Health (CDRH) has created cross-cutting collaborative product groups to better integrate Premarket, post-market and enforcement efforts. The Center is pursuing the development of unique identifiers (UDI) for medical devices, in collaboration with industry and health care providers, in order to easily identify specific devices when post-market questions are raised. CDRH also is considering making electronic reporting of adverse event data mandatory (“eMDR”).
