ARUP Statement on FDA’s Final Rule to Regulate Laboratory-Developed Tests

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.
• Watch ARUP's webinar.

ARUP's Jonathan Genzen, MD, PhD, chief medical officer and senior director of governmental affairs, and Jonathan Carr, JD, compliance officer, discussed the FDA's proposed rule on November 29, 2023. They addressed patient safety, test availability, and the impact on innovation.

• 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.