Premarket Notification Vs Premarket Approval [ 510k Vs PMA ]
A PMA is a more detailed document than a 510k. PMA is used to demonstrate that a new product is safe and effective for the user, and it necessitates both clinical and laboratory testing. The bar is set significantly higher here than it is for 510k submissions.
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 three types of 510(k) premarket notification processes to FDA.
PMA, post-market approval is required for higher-class high-risk devices; PMA contains sufficient scientific evidence to assure that the device is safe and effective for its intended use. PMA required clinical investigations and non-clinical studies.
I hope all readers understood the 510k Vs PMA with this short article. The 510k Vs PMA considerations were done during the project initiation.