What is a Premarket Approval (PMA)?

Premarket Approval (PMA) Definition

A premarket approval (PMA) is the most stringent type of device marketing application required by FDA. Submittal of a PMA is required by the FDA and is the process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. There are two main paths that medical device manufacturers can use to bring moderate- and high-risk devices to market with the FDA’s permission: through submittal of a premarket approval (PMA) request or 510(k) application. A PMA is the more extensive approach, requiring significant evidence that provides “reasonable assurance that the device is safe and effective” through methods like clinical trials. This process is reserved for high-risk Class III medical devices.