Premarket Approval (PMA) is a regulatory process in the United States for certain medical devices that are considered to have a high degree of risk. PMA is required for medical devices that are not substantially equivalent to a device already on the market, or for devices that are subject to a requirement for premarket approval under the Federal Food, Drug, and Cosmetic Act.
The PMA process involves the submission of an application to the FDA that contains detailed information about the device’s safety and effectiveness, including data from clinical trials. The FDA reviews the application and makes a decision about whether to approve the device for marketing in the United States. PMA is typically a longer and more rigorous process than the 510(k) clearance process, which is used for lower-risk devices that are substantially equivalent to an existing device.