Regulating IVDs and LDTs—Mike on Medtech

Regulating IVDs and LDTs—Mike on Medtech

Mike Drues and Sean Fenske discuss proposed regulations around in vitro diagnostics and lab-developed tests.

By Sean Fenske, Editor-in-Chief08.10.21
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at recently proposed legislation regarding in vitro diagnostics and lab developed tests. The previous version of the Verifying Accurate, Leading-edge IVCT Development Act or VALID, which was proposed just before the pandemic, split the industry with the AACC and ACLA not supportive of it, while AdvaMed and CAP were in favor of the proposed legislation. Specifically, the following questions are addressed:

  • First, can you clarify what an IVD and LDT is and what the differences are?
  • How are these currently regulated or how were they regulated?
  • Why is there a call for changes to the regulatory process for these tests.
  • Why is this proposal so divisive to the industry and these organizations?
  • The last time this was proposed, it never even went to a vote. Will this version see the same fate or might this one have a little more support behind it given how important testing was during the pandemic?

Listen to this episode and see what you think of the proposed testing regulations. 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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