Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Special 510(k) program, which offers a pathway for medical device manufacturers making modifications to its own legally marketed device. It is a method for device makers to avoid the need to completely resubmit their device as a new device to the agency. Specifically, we address a number of questions, including:What is the Special 510(k) program and how does it differ from the standard 510(k) program?When is it appropriate for a device manufacturer to use this program?In January 2018, we discussed  the then new alternative 510(k) (click here to listen to that podcast). How is this different from that?Is this yet another specialized version of the 510(k) to better address the industry needs? Are we creating too many “special case” 510(k) variations or is this ultimately a good thing?What are the most important takeaways of this guidance listeners should keep in mind?If you’d like to