The Medical Device Amendments of 1976

The Medical Device Amendments of 1976 are U.S. laws that updated the regulation of medical devices, giving the Food and Drug Administration (FDA) more authority to ensure their safety and effectiveness. Prior to these amendments, many devices were not rigorously tested. The amendments established a clear classification system for devices based on risk, requiring manufacturers to prove that their products are safe before they can be sold. This legislation significantly improved patient safety and provided a framework for the FDA to monitor devices throughout their lifecycle.