FDA Oversight of Lab-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, to discuss the latest update on the U.S. Food and Drug Administration’s (FDA) proposed rule to oversee laboratory-developed tests (LDTs) and what that could mean for laboratories.

Specific topics of discussion include:

•  The FDA’s recent announcement on a proposed rule that would enable the agency to regulate LDTs, and what may happen next.
•  The impact that LDT regulation could have on clinical laboratories.
•  How to stay engaged and informed about regulatory issues.