Medical Device MDR following new FDA Guidance

   FDA Medical Device Reporting (MDR) regulations require firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so that they can be detected and corrected quickly. FDA, in November 2016, issued a Guidance explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in nonconformances. This new Guidance attempts to eliminate confusion by integrating the new Guidance information into the existing regulation. handout is CAPA flow chart