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The FDA’s Final Rule on Lab-Developed Tests: What You Need To Know
ARUP Hosts Informational Webinar on the FDA's Final Rule on LDTs
Summary: The FDA’s final published rule on laboratory-developed tests (LDTs) will result in new oversight that will dramatically shift how clinical laboratories can develop and offer LDTs going forward. In this recorded webinar, ARUP Chief Medical Officer and Senior Director of Governmental Affairs Jonathan Genzen, MD, PhD, and Chief Compliance Officer Jonathan Carr, JD, provide an overview of the requirements included in the final rule and how these requirements differ across certain settings and types of testing. The webinar concludes with a Q&A session in which they 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 In addition, the agency released draft guidance documents on enforcement policies for LDTs during public health responses and emergency situations.
Informational Resources
Timeline for Implementation
ARUP and Industry Partner Resources
Watch the Association for Diagnostics and Laboratory Medicine (ADLM) webinar featuring ARUP’s Jonathan Genzen, MD, PhD, chief medical officer and senior director of governmental affairs.
Reaction to the Proposed Rule
- Explore ARUP’s survey of the lab community’s sentiment of the proposed rule here.
- Read about the ADLM LDT survey here.
- View ARUP’s public comment.
- Read ARUP’s press release on our position.
- The American Clinical Laboratory Association (ACLA) urges the FDA to withdraw the proposal.
- The American Hospital Association (AHA) releases formal opposition.
- Yale experts say the FDA’s proposed rule could have unintended consequences.
- The ADLM says 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.
