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Can You Use a Recalled Device as a Predicate?
Manage episode 371797666 series 2805302
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.
For more medtech news and information, visit www.mpomag.com.
140 episodes
Manage episode 371797666 series 2805302
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.
For more medtech news and information, visit www.mpomag.com.
140 episodes
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