Why Picking a Predicate Can Make or Break Your 510(k) | Device & Conquer | S2:E4

Choosing a predicate device can make—or break—your 510(k) submission, so it's important to choose wisely. In this episode of Device and Conquer , Michelle Lott and Ti Benson break down one of the trickiest parts of the FDA clearance process: how to select a predicate that passes the “substantial equivalence” test without raising new questions of safety and efficacy. You’ll learn how to build a…