FDA Guidance: Medical Device Reporting for User Facilities
Date: 2014-12-10
Source: fda.gov
Abstract:
In 1990, Congress enacted the Safe Medical Devices Act (SMDA) to increase the Information that the Food and Drug Administration (FDA) and manufacturers receive about Serious 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 reports show widespread under reporting. A 1986 General Accounting Office (GAO) study showed that hospitals reported less than one percent of problems with medical devices and, the more serious the problem with a medical 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 under reporting still existed. Implementation of the Medical Device Reporting (MDR) regulation, serious under reporting still existed.
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