Complying with the FDA's rule on LDTs: What you need to do and when

Moderator

• Vince Stine, PhD, Senior Director, Government & Global Affairs, ADLM

Speakers

• Jonathan Genzen, PhD, MD, MBA, Chief Medical Officer, Senior Director of Governmental Affairs, ARUP Laboratories; Professor of Clinical Pathology (Clinical), University of Utah

• Stephen Master, MD, PhD, Division Chief for Laboratory Medicine and Director of Metabolic and Advanced Diagnostics at Children's Hospital of Philadelphia; Associate Professor of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania

Educational need

On May 6, 2024, the Food and Drug Administration published a final rule extending agency oversight to laboratory developed tests (LDTs). Clinical laboratories performing such tests are classified as medical device manufacturers for regulatory purposes. Many ADLM members perform LDTs as part of their job, including developing the tests, verifying and overseeing their performance, and reporting the patient results. The agency rule will significantly impact the ability of our members and their institutions to offer these tests.

Webinar description

Approximately 12,000 laboratories in the United States are eligible to perform laboratory developed tests (LDTs). LDTs meet a vital need in the healthcare system, often serving as the only means of identifying rare medical conditions or providing invaluable information to clinicians when existing FDA cleared or approved tests do not provide the data needed to diagnose and treat a patient. This webinar will build off our June 3rd webinar, focusing on the specific regulatory changes labs need to start working on and the decisions they must make, while offering practical guidance on how to meet the new regulatory requirements. The program will spotlight stages 1 & 2 of the regulation, such as issues pertaining to medical device reporting, registration, and labeling requirements, among others, while also addressing elements of stage 3 involving quality system requirements and design controls.

Join our experts to learn how to comply with this important regulation.

Learning objectives

• Evaluate FDA requirements so you can decide how to remain in regulatory compliance.
• Identify what actions you need to start working on to meet the applicable deadlines
• Describe how to develop the materials/programs necessary to comply with the initial FDA requirements

Target audience

This activity is designed for laboratory directors, laboratory supervisors, laboratory managers (supervisory and/or non-supervisory), clinical laboratory scientists, and other laboratory professionals involved in oversight and testing.

Level

Intermediate