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Definition: Premarket Approval (PMA) and 510(k)

on June 04, 2014

Definition: Premarket Approval (PMA) and 510(k)

Premarket Approval (PMA) is a process of regulatory review to evaluate the safety and effectiveness of certain medical devices. It is the most stringent type of device marketing application required by the Food and Drug Administration. By contrast, a 510(k), also known as premarket notification, is a submission to the FDA that a product is safe and effective by comparing it to at least one similar device already on the market.

Medical device entrepreneurs face a tough decision between the PMA or the 510(k). The PMA is a more arduous regulatory hurdle, but choosing the 510(k) means slower growth.

Image by Gunnar Pippel

Definitions are a weekly feature on eMed for current and aspiring healthcare entrepreneurs.

Category:  Execution  Tags:  Definition, premarket approval, 510(k)

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