Federal Regulation of Medical Devices

GAO discussed its recent report concerning the Federal regulation of medical devices and instruments. GAO noted that: (1) the Food and Drug Administration (FDA) needs to develop a comprehensive medical device information system and develop the capability to analyze trends associated with particular groups of devices; (2) while FDA has not yet completed the final device classification process, it appears that more than 1,000 devices will placed in a category requiring the development of performance standards; (3) FDA has not reviewed the safety and effectiveness of any class III preenactment devices as required by law and may not be able to for many years; (4) the provision of the Medical Device Amendments, allowing FDA to approve new devices for marketing, needs to be reexamined; and (5) although the amendments focused control on medical device performance and manufacture, the leading cause of device failure involved user and maintenance problems.