Comments on the FDA’s Proposed Rule: 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 U.S. Food and Drug Administration’s (FDA) proposed rule on laboratory-developed tests (LDTs) and the comments Mayo Clinic submitted to the FDA.

Their discussion includes:

• How Mayo Clinic responded in its comments to the FDA on the proposed rule on LDTs.
• What comes next after the public comment period has closed effective Dec. 4.
• Quality management systems that are currently in place for laboratories.
• How changes in regulation could impact laboratory operations, patient care, access to testing, and innovation.