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

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.