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Learn how the proposed FDA rule to regulate laboratory-developed tests (LDTs) as medical devices will potentially limit patient access to essential medical care.
Informational Resources From ARUP and Industry Partners, Webinar Recording, and Key Dates
Read ARUP’s response to a request for information from Senator Bill Cassidy, MD (R-LA), on the regulatory framework for diagnostics under the FDA and the Clinical Laboratory Improvement Amendments (CLIA) here.
Read ARUP’s public comment for the House Committee on Energy and Commerce Subcommittee on Health here.
- Explore ARUP’s survey of the lab community’s sentiment of the proposed rule here.
- Read ARUP’s press release on the survey here.
- Download ARUP's 1-Sheet on the survey here.
- April 2024 is when the FDA is expected to release a final rule. Read the proposed rule.
- On December 4, 2023 the public comment period closed.
- See ARUP's public comment here.
- Read ARUP’s press release on our position.
- ARUP Study Characterizes the Use and Importance of Lab-Developed Tests
Webinar Recording Now Available
Watch ARUP’s Jonathan Genzen, MD, PhD, chief medical officer and senior director of governmental affairs, have a conversation with ARUP’s compliance officer, Jonathan Carr, JD, about the FDA’s proposed rule to regulate LDTs as medical devices. This 60-minute webinar was recorded Wednesday, November 29, at 11 a.m. In the webinar, they addressed patient safety, test availability, and the impact on innovation. They also responded to questions from attendees that were submitted before and during the Q&A.
Webinar Presenters
Due to the limited time and the many questions received before and during the webinar that were not addressed, Dr. Genzen has provided written answers on this page. All webinar recipients will also receive an email addressing those questions.
Key Dates Related to FDA Proposed Rule
September 29, 2023: FDA announced proposed rule: Medical Devices; Laboratory Developed Tests.
October 2, 2023: ARUP joined industry partners in opposing the proposed rules.
October 21, 2023: In a letter, 89 laboratories, including ARUP, and industry groups requested that the FDA extend the 60-day comment period.
October 31, 2023: FDA denied the extension.
November 28, 2023 ARUP’s Formal Public Comment to FDA
December 4, 2023: Deadline for public comment
ARUP and Industry Partner Resources
American Clinical Laboratory Association (ACLA) and American Hospital Association (AHA) Release Formal Opposition to FDA’s Proposed Rule to Regulate LDTs
ACLA called the proposal "misguided" and called for continued conversations regarding legislation to further regulate LDTs. Read more.
AHA said LDTs are critical for patient access to timely diagnostic information for many conditions for which no FDA-approved test exists. Read more.
Yale Experts: The FDA’s Proposed Rule on Lab-Developed Tests Could Have Unintended Consequences
“We’re actually seen more problems with the FDA-cleared commercial tests than we have with our laboratory developed tests,” said Marie-Louise Landry, MD, professor of laboratory medicine and of medicine (infectious diseases). Read more.
Association for Diagnostics and Laboratory Medicine (ADLM): FDA Goes All in to Regulate Laboratory Developed Tests
If the FDA finalizes its proposal to regulate LDTs, it is likely that the agency will face lawsuits, which could delay implementation of the rule and could set up a Supreme Court fight. Read more.
Association for Diagnostics & 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.
ARUP Article on Panel Discussion at Utah Life Sciences Summit
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.
Letter to FDA Commissioner Robert M. Califf, MD, From 89 U.S. Laboratories and Industry Groups
American Clinical Laboratory Association Press Release
ARUP Article on Results of Study Examining Use and Impact of LDTs on Patient Care
