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What are the requirements for medical device reporting?

The Food and Drug Administration receives hundreds of thousands of reports each year about injuries, malfunctions and deaths related to medical devices. One way the FDA monitors medical devices is through medical device reporting. It is also used to detect possible safety issues and analyze the benefits and risks of the devices when used.

Entities required to report defects with devices include manufacturers, importers and device user facilities. The FDA also encourages patients, medical professionals and caregivers to submit reports regarding any adverse incidents related to the device.

A device user facility is a hospital, outpatient facility, nursing home, ambulatory surgical facility or outpatient diagnostic facility, but never a physician's office. These facilities are required to report any device-related deaths to the FDA and to the medical device manufacturer. They must report device-related injuries to the manufacturer.

Importers are required to report to the FDA and the manufacturer if one of the medical devices they imported has played a role in an injury or death. Notification only has to be made by the importer to the manufacturer if a device has malfunctioned and the importer believes it could cause serious injury or death if not resolved.

When a manufacturer learns that any of their medical devices have caused injury or death, they must report it to the FDA. A manufacturer must also report to the FDA if they are informed of a device malfunction that could lead to serious injury or death.

Voluntary reporting can be done by anyone, including medical professionals. It can be done using an application created by the FDA that can be installed on tablets and smartphones. It can also be done by downloading and completing a form found on the FDA website.

The Manufacturer and User Facility Device Experience database holds mandatory reports filed from August 1996 to present by manufacturers and importers, 1991 to present by user facilities and voluntary reports filed after June 1993. All of these reports can be accessed by the public.

Source: FDA, "Medical Device Reporting (MDR)," accessed Jan. 27, 2017

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