The Special 510k Program
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 d...