What Happens When the EUA Period Ends?—Mike on Medtech

What Happens When the EUA Period Ends?—Mike on Medtech

Mike Drues and Sean Fenske discuss what happens when the emergency use authorization period ends and what device makers need to do then.

By Sean Fenske, Editor-in-Chief12.13.22
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at what happens to products on the market under the FDA’s emergency use authorization (EUA). Once the EUA period ends, what happens to these products? As President Biden has already declared the pandemic to be over, this timeframe will be approaching quickly. Specifically, the following questions are addressed:

  • Could you please explain what an EUA is within the regulatory context of the pandemic?
  • Under whose authority is the pandemic deemed over such that the status of devices on the market under EUAs become a concern?
  • How will the FDA handle these EUA products?
  • What should companies be doing now if they want to keep their products on the market after the EUAs expire?
  • Are there any considerations companies should keep in mind with an EUA product?
  • Are there any reasons a company may not want an EUA product to go through a full regulatory review?
  • What are the most important takeaways with all of this for medical device manufacturers?

Listen to this episode and see if the end of EUAs impacts your company. 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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