Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Safety and Performance Based 510k pathway, which offers a pathway for medical device manufacturers to use performance criteria in place of a predicate device for clearance. This option, previously known as an Abbreviated 510k, is only available for a select group of well-understood devices that meet FDA-identified performance criteria to demonstrate the device is as safe and effective as a legally marketed device. Specifically, we address a number of questions, including:What is the Safety and Performance 510k?How does it differ from other variations of the 510k, such as the traditional version or the Special 510k?When should a manufacturer consider using this 510k?How does using performance criteria differ from citing a predicate device?Is this simply another way to get “me too” products to market quicker or is there more to it than that?Is this a incentivized way to have companies