To Regulate or Not to Regulate…LDTs, Part 2—Mike on Medtech

To Regulate or Not to Regulate…LDTs, Part 2—Mike on Medtech

Mike Drues and Sean Fenske continue the discussion on the controversy involving LDTs and whether the FDA should regulate them.

By Sean Fenske, Editor-in-Chief02.07.23
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue to discuss lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. How would FDA oversight impact quality and timeliness of care? How do LDTs relate to what happened with Theranos? Specifically, the following questions are addressed between the two parts of this podcast presentation:

  • Can you start today’s conversation by explaining why we’ve selected this topic for today’s discussion? Has there been an update to this debate?
  • What is an LDT?
  • Why do labs develop their own LDTs?
  • Can you provide a couple of examples of LDTs?
  • Currently, are LDTs regulated? Why and who is involved?
  • You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?
  • Is there precedent we can examine for using enforcement discretion to not regulate LDTs?
  • What is the relationship between LDTs and Theranos?
  • What is your recommendation for companies developing LDTs and/or IVDs?
  • Do you have suggestions for improving the status quo with regard to LDTs?
  • What are the important takeaways from this discussion manufacturers should keep in mind?

Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company’s products. 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.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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