The Safe Medical Devices Act

The Safe Medical Devices Act, enacted in 1990, enhances the regulation of medical devices to ensure patient safety. It requires manufacturers to report device-related injuries and deaths, promotes better monitoring of devices, and allows the FDA to take faster action on unsafe products. The act also encourages post-market surveillance, meaning that devices are monitored even after they are approved for use. Overall, it aims to provide more protection for patients by ensuring that medical devices are safe and effective throughout their use.