Radiation-Emitting Products

Mammography Facilities: Understanding Your Role in Medical Device Reporting

Did you know that the Food and Drug Administration conducts post-market surveillance of medical devices, including mammography equipment? The Safe Medical Device Act of 1990 and the final Medical Device Reporting (MDR) rules published in 1995 imposed reporting requirements on the medical device industry, importers, and medical device user facilities, which includes mammography facilities. You can find medical device reporting requirements at Title 21 Part 803 of the Code of Federal Regulations. This mechanism of reporting allows the FDA and manufacturers to identify, monitor, and correct problems, as well as to check on how effective corrective actions have been. It is essential that device manufacturers, importers, and user facilities understand both their responsibilities and how to properly fulfill their reporting obligations.

Two of the most important sources of medical device reporting and adverse event information are the device user facilities and health care professionals. A device user facility means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic (including mammography) facilities and treatment facilities. A device user facility is an integral component in the medical device reporting chain because:

  • Health Care Professionals consistently have hands-on interaction with medical devices and may be the first to observe adverse interactions between medical devices and patients.
  • Device user facilities are the most common place for a medical device and a patient to interact, where they are being used in real-time for diagnosis and treatment

There are two types of reporting requirements for devices user facilities: mandatory and voluntary. Device user facilities must report a suspected medical device-related death to the FDA and to the device manufacturer. A device user facility must also report medical device-related serious injury to the manufacture or if the manufacturer is unknown, the user facility can report this type of event to the FDA. A device user facility can report an MDR manually using Form FDA 3500A - Mandatory Reporting or electronically using the FDA’s eMDR- Electronic Medical Device Reporting.

The other type of medical device reporting is a voluntary report. If a medical device failure to perform its essential function compromises the device’s effectiveness and could cause or contribute to death or serious injury, it has malfunctioned. The two areas where a mammography or other radiography user facility will most likely see device malfunctions manifest themselves are radiation dose and image quality. The FDA encourages device user facilitates, health care professionals, and patients to electronically submit voluntary reports of medical device adverse events or product problems through MedWatch.

For more information on mandatory and voluntarily reporting for device user facilities, please refer to the Medical Device Reporting for User Facilities.

Page Last Updated: 02/02/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English