Premarket Notification Vs Premarket Approval [ 510k Vs PMA ]

Class II medical devices require a 510k submission (premarket notification), while Class III medical devices require a PMA (premarket approval), but what is the difference in the process between the two?

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.

The goal of a 510k is to give recorded proof to the FDA that the device in question is substantially equivalent to a predicate device that has already cleared the 510k process. You’ll need to compare and contrast your device with the predicate device to prove significant equivalence. While laboratory testing is typically required, human testing is usually not needed for 510k submissions. Additional information for your 510k application includes design inputs and design verification procedures, and intended use and indications for usage.

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.

Traditional
Abbreviated
Special

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.

510k Vs PMA

Premarket Notification Vs Premarket Approval [ 510k Vs PMA ]

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