Medical Device Approval and Regulation

Medical device approval and regulation refer to the processes that ensure medical devices are safe and effective before they can be sold to the public. In the U.S., the Food and Drug Administration (FDA) is responsible for this oversight. Manufacturers must submit detailed information about their devices, including testing results, for FDA review. Depending on the device's complexity and risk level, the approval process may vary. This regulation helps protect patients by ensuring that medical devices meet established safety and performance standards before they are used in healthcare settings.