Medtech Matters

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 device is used in a 510k submission?Given we’ve laid the groundwork, can you now please explain how a recalled device can be used as a predicate device?Is there any argument that can be made for having it be valid to use a Class 1 recall device as a predicate?Do you think a recall should invalidate a device from being used as a predicate? Or, would you ever suggest a recalled device to a client to be used as a predicate?I know some have argued for a “cap” to a device being used as a predicate, for example, nothing older than