510 k Vs PMA

Premarket Notification (510k) Vs Premarket Approval (PMA)   510(k) premarket notification means to prove the substantial equivalence between subject device and a predicate device. Predicate device is a legally marketed 510(k) cleared devices. There are 3 types of 510(k) premarket notification process to FDA.   Traditional Abbreviated Special PMA, post market approval is required for…