Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known to evoke a fearful, negative response by medical device professionals.

In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, known in the industry as Mr. Regulatory, about the reasons why the PMA process is so dreaded by manufacturers bringing a Class III medical device to market in the United States.