PMA

A PMA has to show reasonable assurance of safety and effectiveness on its own merits, usually with clinical data, rather than by comparison with a predicate. It is the most demanding US route, and changes after approval often need PMA supplements.

PMA means any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein. “PMA” includes a new drug application for a device under section 520(1) of the act.

21 CFR, 814.3