To Regulate or Not to Regulate…Lab Developed Tests, Part 1—Mike on Medtech

To Regulate or Not to Regulate…Lab Developed Tests, Part 1—Mike on Medtech

Mike Drues and Sean Fenske review the controversy surrounding lab developed tests and discuss whether or not it makes sense for FDA to regulate them.

By Sean Fenske, Editor-in-Chief01.31.23
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the debate over lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. What would this type of oversight do to the need for speed with these types of tests? Would FDA supervision make things safer and also avoid future situations like the Theranos debacle? 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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