Premarket Notification Vs Premarket Approval
510k Vs PMA
510(k) premarket notification means to prove the substantial equivalence between the subject device and a predicate device. Predicate device is a legally marketed 510(k) cleared device. There are 3 types of 510(k) premarket notification processes to FDA.
PMA, post-market approval is required for higher-class high-risk devices, PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. PMA required clinical investigations and non-clinical studies.