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ARUP Laboratories to Host Informational Webinar on the FDA’s Final Rule on Lab-Developed Tests
Register here
The FDA’s Final Rule on LDTs: What You Need To Know
Date: May 23, 2024
Time: 10 a.m. (MDT)
Summary: The FDA has now published its final rule on laboratory-developed tests (LDTs). The FDA’s new oversight will dramatically shift how clinical laboratories can develop and offer LDTs going forward, and more importantly, how we can continue to meet the needs of patients. Please join ARUP Chief Medical Officer and Senior Director of Governmental Affairs Jonathan Genzen, MD, PhD, and Chief Compliance Officer Jonathan Carr, JD, for an overview of the requirements included in the final rule and how these requirements differ across certain settings and types of testing. The webinar will conclude with a Q&A session during which our presenters will share their perspectives on questions submitted by registered attendees.
The FDA released its final rule to regulate laboratory-developed tests (LDTs) on April 29, 2024. In addition, the agency released draft guidance documents on enforcement policies for LDTs during public health responses and emergency situations.
Timeline for Implementation
Informational Resources
- Explore ARUP’s survey of the lab community’s sentiment of the proposed rule here.
- Read about the Association for Diagnostics and Laboratory Medicine (ADLM) LDT survey here.
- FAQs
Previous Webinar from November 2023:
What the FDA’s Proposed Rule to Regulate Lab-Developed Tests Means for Hospitals and Health Systems.
ARUP's Jonathan Genzen, MD, PhD, chief medical officer and senior director of governmental affairs, and Jonathan Carr, JD, chief compliance officer, discussed the FDA's proposed rule on November 29, 2023. They addressed patient safety, test availability, and the impact on innovation.
- Watch ARUP's previous webinar.
- Slide deck from webinar
- Dr. Genzen's written answers to questions from participants
ARUP and Industry Partner Resources
Reaction to the Proposed Rule
- View ARUP’s public comment.
- Read ARUP’s press release on our position.
- The American Clinical Laboratory Association (ACLA) urged the FDA to withdraw the proposal.
- The American Hospital Association (AHA) released formal opposition.
- Yale experts said the FDA’s proposed rule could have unintended consequences.
- The Association for Diagnostics and Laboratory Medicine (ADLM) said the FDA’s proposed rule could set up a Supreme Court fight. Read more.
- ARUP study characterizes the use and importance of lab-developed tests.
ARUP LabMind Podcast
- Meghan Delaney, DO, MPH, division chief of pathology and laboratory medicine at Children’s National Hospital in Washington, D.C., joins Dr. Genzen to explain that LDTs she develops are often FDA-approved tests that must be modified to ensure they are effective for use in children. Listen here.
Association for Diagnostics and Laboratory Medicine Laboratories Podcast
- Octavia Peck Palmer, PhD, director of the Division of Clinical Chemistry at the University of Pittsburgh, talks with Dennis Dietzen, PhD, medical director of laboratory services at St. Louis Children’s Hospital, about why the proposed FDA rule could hinder patient access to essential LDTs. Access podcast here.
