Mike on Medtech: Emergency Use Authorizations

Mike on Medtech: Emergency Use Authorizations

Mike Drues and Sean Fenske discuss what happens when the pandemic ends and what companies with EAUs need to do.

By Sean Fenske, Editor-in-Chief01.26.21
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss one of the most talked about regulatory elements of the last ten months—emergency use authorizations (or EUAs). The conversation is about what they are, when they are used, and, perhaps most importantly, what happens when the emergency is deemed over. Specifically, the following questions are addressed:

  • Can you provide a full explanation of the EUA and when it is used?
  • What happens to products that have received an EUA to get to market during the pandemic once the emergency is deemed over?
  • How does an EUA fit within a company’s regulatory strategy?
  • Can a company use real-world evidence from a product’s time on the market as a result of an EUA in its regulatory submission for that product?
  • For companies that have been granted an EUA, what are the most important things to keep in mind as we hopefully get closer to the end of the pandemic?

Listen to this episode and see what you think of EUAs and whether your firm needs to take action as a result of one of your products having one. 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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