Medical Device Reporting Definition

Medical Device Reporting is the means by which adverse events and malfunctions with medical devices are reported to the Food and Drug Administration. Under the Safe Medical Devices Act of 1990, device user facilities including hospitals and nursing homes must report known device-related deaths to the FDA and the manufacturer.

Medical Device Reporting was implemented in order to equip the FDA with the information necessary to detect and correct medical device malfunctions and ensure safety in the healthcare industry.