Can You Use a Recalled Device as a Predicate?—Mike on Medtech

Can You Use a Recalled Device as a Predicate?—Mike on Medtech

Mike Drues and Sean Fenske discuss why and how a medical device manufacturer might use a device that went through a recall as a predicate for a new product.

By Sean Fenske, Editor-in-Chief06.20.23
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 10 years. Should there be a minimum amount of time a device should be on the market in clinical use to be able to be used as a predicate?
  • What are the most important takeaways?

Listen to this discussion and see if you think using a recalled device as a predicate is a good regulatory strategy. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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