Federal Regulation of Medical Devices--Problems Still to be Overcome

摘要

The 1976 amendments to the Federal Food, Drug, and Cosmetic Act require the Food and Drug Administration (FDA) to regulate medical devices and ensure their safety and effectiveness. FDA has not completed many of the tasks required in the law. For example, it has not completed the process of classifying devices, begun a review of preenactment devices, or promulgated performance standards. FDA also has not developed a comprehensive system to collect and analyze data concerning medical devices. In the absence of such a system, GAO interviewed 68 experts to obtain their views on medical device regulation. Many of the experts questioned the usefulness of having FDA develop performance standards for a large number of devices, and some questioned the usefulness of having FDA review all preenactment devices. Their views on these and other matters suggest that the Congress may wish to consider modifying several provisions of the act.