FDA to Require Medical Device Manufacturers to Submit MDRs Electronically
February 19, 2014 | Risk Management News
The U.S. Food and Drug Administration (FDA) has published a final rule revising the requirements of its postmarket medical device reporting regulation. The final rule requires device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to FDA in an electronic format. Electronic reporting is also available to user facilities of medical devices, but the final rule permits user facilities to continue to submit written reports to FDA if they choose.