Final Rule on LDTs May Be Coming Soon: Bill Morice, M.D., Ph.D.

In this 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 Food and Drug Administration’s (FDA) progress on making a final rule around regulating laboratory-developed tests (LDTs). 

Their discussion includes:

• How the FDA’s proposed rule on regulating LDTs has advanced to the White House Office of Management and Budget (OMB) for review, and what to expect in the coming months.
• Ongoing work around the Saving Access to Laboratory Services Act (SALSA).
• How laboratorians and pathologists can stay engaged on these important issues.