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.

[@TheSensation19]

The ruling reads as though labs are now allowed to not ask for consent before givin them experimental treatments. Can you elaborate on that claim?

[@jfitzpatrick6108]

Does this mean it would be "illegal", i.e. a criminal offense for John Doe to possess PCR Grade Water or any other substance designated "RUO"?

[@mennowitteveen3313]

This profoundly saddens me. I was thinking of starting a company to use DNA sequencing to diagnose rare conditions. However this completely breaks the business model.