Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous studies have shown widespread underreporting.
A GAO follow-up study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed.
A final rule published in the Federal Register on December 11, 1995, addresses the comments received and the mandated changes.
The Food and Drug Administration Modernization Act (FDAMA) made four changes that affected MDR, effective 2/19/98: