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 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. Send us Fan Mail For more medtech news and information, visit https://www.mpomag.com.