FDA’s Refusal to Accept Policy for 510(k)s—Mike on Medtech

FDA’s Refusal to Accept Policy for 510(k)s—Mike on Medtech

Mike Drues and Sean Fenske review the latest guidance on Refuse to Accept and why the occurrence happens much too often.

By Sean Fenske, Editor-in-Chief10.18.22
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s policy known as Refuse to Accept (RTA) as it relates to 510k submissions. Sadly, some companies are rejected due to Refuse to Accept as many as three times, which is a completely avoidable problem. Specifically, the following questions are addressed:

  • Please start with an explanation of the FDA’s review process. What happens after the agency receives a submission?
  • This is the third Refuse to Accept guidance from FDA. Can you provide an overview of all three and explain how they should be used?
  • What was the agency’s goal in releasing these guidance documents?
  • Do you have examples you can share of submissions rejected on RTA review?
  • The agency has tried to modernize with the offering of some etools. Can you explain what these are and what advantages and disadvantages there are to using them?
  • How should a medical device manufacturer view these documents and how should they use them?
  • What are the options for a device maker upon the rejection of a submission?
  • What are today’s takeaways with regard to Refuse to Accept guidance from the FDA?

Listen to this episode and see if you better understand how to avoid a Refuse to Accept rejection. 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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