News — WASHINGTON – The U.S. Food and Drug Administration (FDA) has long sparked controversy with its proposals to regulate laboratory developed tests (LDTs) as medical devices. Now, with the agency issuing a final rule that aims to confine the practice of laboratory medicine within the agency’s device manufacturing mandates, experts are warning of unintended consequences — for patients, healthcare providers, and the innovation essential to 21st-century medical care.
Join experts from the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) for a deep dive into the FDA final rule, the complexities and uncertainties of its potential implementation, and the latest insights on how lab medicine professionals are seeking to maintain access to essential LDTs for patients.
Speakers will address:
- The FDA’s new regulatory framework:Learn about the scope and intent of the new rule, its regulatory requirements, and the exceptions it includes.
- Expert guidance:Hear from expert speakers Dr. Stephen Master from the Children's Hospital of Philadelphia and Dr. Jonathan Genzen from the University of Utah, who will delve into the implications of the rule for laboratories and outline the critical decisions that need to be made.
- What’s next for the FDA and labs: Speakers will address how legal and other challenges could shape the trajectory of the FDA’s actions.
Approximately 12,000 U.S. laboratories perform LDTs, tests that are essential for diagnosing rare medical conditions and providing critical data when FDA-approved tests fall short. Laboratory medicine professionals create and perform LDTs as a service to clinicians and patients.
On May 6, 2024, the FDA published a final rule extending oversight to LDTs and reclassifying clinical laboratories as medical device manufacturers for regulatory purposes. ADLM members who develop, verify, and report LDT results will be significantly affected.
Laboratories are already regulated by the Centers for Medicare and Medicaid Services (CMS), which assures test performance, personnel performance and qualifications, and onsite inspections.
This webinar will explain the FDA’s rule, highlight necessary decisions for labs, and offer an update on factors influencing the rule's future.
When: Monday, June 3, 2024, at 1 p.m. Eastern Time
Where: Live webinar
Who:
- Stephen Master, Children's Hospital of Philadelphia
- Jonathan Genzen, ARUP Laboratories/University of Utah
RSVP: Email Christine DeLong, ADLM Associate Director, Communications & PR at [email protected].
ABOUT THE ASSOCIATION FOR DIAGNOSTICS & LABORATORY MEDICINE (ADLM)
Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit .
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