FDA Issues Final Rule to Regulate LDTs: Bill Morice, M.D., Ph.D.

Answers From the Lab

In this special episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Division of Clinical Microbiology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the final rule issued by the U.S. Food and Drug Administration (FDA) on April 29, 2024, to make explicit its plan to regulate laboratory-developed tests (LDT) as medical devices under the Federal Food, Drug, and Cosmetic Act.

Their discussion includes:

  • Highlighting key points, exceptions, and the phased implementation plan of the final rule.
  • How the FDA’s final rule compares to its proposed rule from last year.
  • How the news may impact laboratories, health systems, health agencies, and manufacturers.
  • Uncertainties that still remain regarding the future of laboratory-developed tests.

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.

Luci Gens

Luci Gens is a marketing manager at Mayo Clinic Laboratories. She joined Mayo Clinic in 2022 and has over ten years of experience in hospital-based marketing and communications.