When it comes to a PMOA there are three regulatory sectors that can be exploited: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation (CBER) and Center for Devices and Radiological Health (CDRH). With these centers or sectors, the medical device can go to any one of these routes. However, if the device goes to the wrong one it can be a waste of time. So depending on the device, several regulatory pathways are available to the applicants including 520(k) premarket notification, reclassification, product development (PDP), de novo review, and premarket approval (PMA) application. Looking at the FDA website they describe how each of these regulatory pathways is done. In essence, if the medical device is completely new in terms of the device and using a bioactive component then the process, regular less of the pathway, will take extensive time and evaluation before even FDA can pass it.