Medical Device Reporting

Course overview

Course Overview The Food and Drug Administration (FDA) uses medical device reporting (MDR) to receive information about adverse medical device events from manufacturers, importers, and user facilities (which include health care facilities, providers and suppliers) in an effort to quickly correct the adverse events. This course provides the information necessary to comply with medical device reporting requirements. This course is not intended to replace facility-specific training on policies and procedures related to medical device reporting.