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Premarket Approval (PMA)

When a medical device manufacturer wants to bring a new class III medical device to market, they must go through a rigorous premarket approval (PMA) process with the Food and Drug Administration (FDA). One of the most critical components of this process is the submission of clinical data to demonstrate the safety and effectiveness of the device.

Why Clinical Data Is Important

Clinical data is essential for the PMA submission process because it provides the FDA with the evidence needed to determine if a device is safe and effective for its intended use. If the PMA application lacks valid clinical information and scientific analysis on sound scientific reasoning, it could impact FDA’s review and approval of the application. More information on clinical studies for PMA submission can be found under PMA Clinical Studies on the FDA website.