Product Approval Pathways

This presentation, for the non-regulatory professional, provides an overview of medical devices and their regulatory pathways.  One of the most important aspects is to know where to begin.  FDA’s Center for Devices and Radiological Health (CDRH) regulates companies that design, manufacture, repackage, relabel, and/or import medical devices into the United States.  A premarket submission is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of medical devices.  There are three steps to obtaining marketing clearance from CDRH.  STEP ONE is to make sure the product to be marketed meets the definition of a medical device.  STEP TWO is to determine the class of regulatory control, i.e. Class I, II or III device.  And, STEP THREE is to select the appropriate regulatory pathway.  These three steps, along with explanation and comparison of the Premarket Notification 510(k) and the PMA Premarket Approval pathways, are presented.