FDA Regulation of Medical Devices—Moving Beyond the Horse and Buggy

Before the Medical Device Amendments of 1976, many people experienced serious harms due to high-profile medical device failures, including cardiac pacemakers and the Dalkon Shield intrauterine device. In 1970, Dr Theodore Cooper, the assistant secretary for health, testified to Congress on the more than 10 000 medical device injuries over a 10-year period that were not investigated. Increased awareness of the harms of limited US Food and Drug Administration (FDA) regulation led to the first statutory premarket regulation of medical devices.