ABSTRACT
In 1969, the Department of Health, Education, and Welfare appointed a special committee (the Cooper Committee) to review the scientic literature associated with medical devices. The committee estimated that over a 10 year period, 10,000 injuries were associated with medical devices, of which 731 resulted in death. The majority of problems were associated with three device types: articial heart valves, cardiac pacemakers, and intrauterine contraceptive devices. These activities culminated in the passage of the Medical Devices Amendments of 1976.
