Medical Device Reporting

Medical Device Reporting

Learn to state the mission of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).

Magnifi Group
Updated Jun 09, 2020

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.