Premarket approval (PMA) is a regulatory process by which the U.S. Food and Drug Administration (FDA) evaluates the safety and effectiveness of high-risk medical devices before they can be marketed. This thorough review ensures that the devices meet the required standards for patient safety and efficacy, particularly important for neuroprosthetic devices that interact directly with the nervous system. The PMA process is crucial for maintaining public trust in medical technologies and promotes innovation while safeguarding patients.
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