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Medical Device Regulation: Overview


Medical Device Databases

About the Center for Devices and Radiological Health

The Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. They assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.


Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The MAUDE (Manufacturer and User Facility Device Experience) database contains MDRs submitted by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

Understanding the Regulatory Pathway

Bioengineering Librarian

Jan Comfort's picture
Jan Comfort
Cooper Library, Room 304