Can You Use a Recalled Device as a Predicate?

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA policy regarding the use of a recalled device as a predicate in a 510k submission. Is it a good idea? What considerations are there for doing so? Specifically, the following questions are addressed: First, would you please explain the various levels of a recall as it relates to a medical device and what each level means?Can you quickly remind us of how a predicate d...