Premarket approval (PMA) is a regulatory process by which the U.S. Food and Drug Administration (FDA) evaluates the safety and effectiveness of medical devices before they can be marketed to the public. This rigorous process requires manufacturers to provide comprehensive evidence, including clinical data, to demonstrate that their devices meet established standards for safety and effectiveness. PMA is typically required for Class III medical devices, which are considered high-risk and have the potential to cause significant harm if not properly designed and tested.
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