In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the U.S. Food and Drug Administration’s (FDA) recently proposed rule that if finalized, would phase out its current enforcement discretion used for laboratory developed tests (LDTs), and regulate all laboratory tests as medical devices regardless of where they are manufactured.

Specific topics of discussion include:

• A brief history of the FDA’s oversight of LDTs and related legislative efforts.
• The notice and comment rulemaking process that will occur over the next 60 days, and how to submit public comments to the FDA.
• How this proposed rule may impact laboratories.

Podcast episode

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Podcast episode in video format

Answers from the Lab is a Mayo Clinic Laboratories curated podcast sharing knowledge and advancements regarding the state of testing, laboratory science, and the people who make it all happen behind the scenes. 

Information in this post was accurate at the time of its posting.