Regulatory Shifts: How The FDAs Final Rule Could Shape Lab Developed Genetic Tests and Genetic Counseling Practice

Join us as we discuss how the FDA's Final Rule on Laboratory--Developed Tests (LDTs) could shape the genetic testing industry and genetic counseling practice. We will cover the current state of regulation of laboratory tests including FDA authorization, CLIA certification, and CAP accreditation before exploring the details of the Final Rule, its historical context, and its implications for labs, clinicians, and patients. With ongoing litigation, advocacy, and political influences at play, this session will provide a timely overview of the evolving landscape of LDT regulation. 

Presented by: 

NSGC Lab and Industry SIG
1. Emily Dalton, MS, CGC
2. Jennifer (Jen) Leib, Sc.M., C.G.C. 

Date:

April 16, 2025 

Learning Objectives:

1. Define the difference between an LDT and FDA-approved IVD and provide examples of each.
2. Explore the regulatory landscape of laboratory testing and different entities involved.
3. Understand how the Final Rule on LDTs changes the definition of medical device, how the FDA will phase out its practice of enforcement discretion, and ongoing advocacy efforts to rescind the rule.
4. Identify the challenges and opportunities this regulatory change creates for genetic counselors. 

Continuing Education Unit Approval: 

The National Society of Genetic Counselors (NSGC) has authorized the National Society of Genetic Counselors (NSGC) to offer up to .1 CEUs or 1 Category 1 contact hour for the activity, Regulatory Shifts: How The FDAs Final Rule Could Shape Lab Developed Genetic Tests and Genetic Counseling Practice. The American Board of Genetic Counseling (ABGC) will accept CEUs earned by participating in this program for the purposes of genetic counselor recertification. 

Successful Completion: 

1. View recording
2. Pass quiz
3. Complete evaluation