Medical device reporting (MDR) is the procedure for the
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
to get significant
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report any
adverse event
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can ther ...
caused by the device to
MedWatch program for reporting significant adverse events or product problems with medical products.
History
Legislation requiring device user facility reporting was enacted by
Congress
A congress is a formal meeting of the representatives of different countries, constituent states, organizations, trade unions, political parties, or other groups. The term originated in Late Middle English to denote an encounter (meeting of ...
to increase the amount of information the Food and Drug Administration (FDA) and
device manufacturers receive about problems with medical devices. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous studies have shown widespread
underreporting Under-reporting usually refers to some issue, incident, statistic, etc., that individuals, responsible agencies, or news media have not reported, or have reported as less than the actual level or amount. Under-reporting of crimes, for example, makes ...
. A 1986
General Accounting Office
The U.S. Government Accountability Office (GAO) is a legislative branch government agency that provides auditing, evaluative, and investigative services for the United States Congress. It is the supreme audit institution of the federal gover ...
(GAO) study showed that less than one percent of device problems occurring in hospitals are reported to the FDA, and that the more serious the problem with a device, the less likely it was to be reported. A GAO follow-up study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed.
Under the
Safe Medical Devices Act of 1990 (SMDA), device user facilities must report device-related deaths to the FDA and the manufacturer, if known. The facilities must also report device-related serious injuries to the manufacturer, or to the FDA if the manufacturer is not known. In addition, SMDA also required that device user facilities submit to FDA, on a semiannual basis, a summary of all reports submitted during that time period. The device user facility reporting section of SMDA became effective on November 28, 1991.
To implement SMDA, FDA published a tentative final rule in the
Federal Register on November 26, 1991, inviting comments; over 300 comments were received. On June 16, 1992, the President signed into law the Medical Devices Amendments of 1992 (Public Law 102–300) making minor changes. A final rule published in the Federal Register on December 11, 1995, addresses the comments received and the mandated changes.
Update on FDAMA
The
Food and Drug Administration Modernization Act
The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes ...
(FDAMA) made four changes that affected MDR, effective 2/19/98:
* Manufacturers and distributors/importers do not need to submit annual certification.
* Domestic distributors are no longer required to file MDR reports, but must continue to maintain complaint files.
* Importers (initial distributors for devices manufactured overseas and imported into the USA) must continue to file MDR reports.
* User facilities must now file an annual report instead of semiannual reports, and Sentinel reporting by user facilities was proposed.
See also
*
Post-market surveillance
References
External links
*{{cite web, url=https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm#1, title=Medical Device Reporting (MDR), website=Fda.gov, accessdate=14 October 2017
Food and Drug Administration
Regulation of medical devices
Regulation in the United States