Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the still relatively new Breakthrough Devices Program (click to review the guidance). Since it was only introduced last year, there are still a number of questions device manufacturers have about the program. With this in mind, we thought it would be a great topic to cover as part of this “Beyond 510(k)/PMA” series. Specifically, we address a number of questions, including:Wh...