The 1976 Medical Device Amendments: a status report.

The FDA's Bureau of Medical Devices has been charged with implementing the 1976 Medical Device Amendments. The bureau's activities have been concentrated in three areas--general controls, medical device standards, and device evaluation. In the area of general controls, the bureau has implemented regulations concerning good manufacturing practices, registration, product listings, banned devices, and administrative detention. Several other activities are planned for the near future, including the development of a mandatory experience reporting regulation, a restricted device regulation, and device repair, replacement, or refund provisions. FDA intends to rely on voluntary standards for medical devices, but will develop and promulgate regulatory standards as needed to protect the consumer. The device classification procedures have resulted in classification recommendations for approximately 1900 generic categories of products to date.