Proposed Regulations for Laboratory Developed Tests: Bill Morice, M.D., Ph.D.

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.

Their discussion includes:

• 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.