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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 Jan 14, 2025
What you'll learn
- State the mission of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
- Describe medical device reporting requirements for manufacturers, distributors, and user facilities.
- Identify medical devices that require tracking through the distribution channel.
- Describe the consequences of failing to comply with medical device reporting requirements.
Course Description
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.
