Podcast Examines the Impact of the FDA’s Proposed Rule on Laboratory Developed Tests

ASCP is sharing with our members a recent Inside the Lab podcast the Society hosted on the topic of laboratory developed tests (LDTs). The podcast is a resource for those interested in learning about LDTs and how they affect the medical laboratory and the delivery of quality patient care.

In this podcast, hosts ASCP Chief Medical Officer Ali Brown, MD, FASCP, and ASCP Executive Editor of Journals Kelly Swails, MLS(ASCP), moderate a discussion on the implications of the U.S. Food and Drug Administration’s (FDA) proposed regulations for LDTs. Guest panelists are Gregory Sossaman, MD, MASCP, clinical pathologist and service line lead for pathology and laboratory medicine at Ochsner Health, Jonathan Genzen, MD, PhD, FASCP, clinical pathology professor at the University of Utah and chief medical officer and senior director of government affairs at ARUP Laboratories, and Matthew Schulze, senior director for the ASCP Center for Public Policy at ASCP.

ASCP’s panelists share their concerns about the labor and costs involved in complying with the proposed rule and describe how laboratory professionals might be forced into situations where they have to deny care if these regulations are enacted.

Listen in to understand why public opinion favors the proposed rule and learn how to share your concerns with the FDA during the public comment period which extends until December 4, 2023. Click here.

To read more articles from this issue of ePolicy, click here. To learn more about ePolicy News and access past newsletters and articles, click here.

For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.