Premarket approval (PMA) is a rigorous regulatory process mandated by the U.S. Food and Drug Administration (FDA) for the evaluation and approval of high-risk medical devices before they can be marketed. This process requires manufacturers to provide substantial evidence of the device's safety and effectiveness through clinical trials, detailed documentation, and comprehensive testing data. The PMA process is designed to ensure that any device that poses significant risks to patients meets strict safety standards and performs as intended.
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