Medical Device Reporting

The FDA’s Medical Device Reporting (MDR) regulations mandate the reporting of serious injury and death from device malfunctions to the FDA by device manufacturers to assure a mechanism that expeditiously identifies and corrects device-related problems. The Safe Medical Devices Act (SMDA) of 1990 strengthened the Medical Device Act of 1976 and required post-market product monitoring and the tracking of certain devices (see Medical Device Tracking) to the level of the patient.