Your input matters! An ARUP expert will answer your questions on hospital impact as the FDA rule will potentially limit patient access to essential medical care.
What the FDA's Proposed Rule to Further Regulate Lab-Developed Tests Means for Hospitals and Health Systems
Join ARUP’s Jonathan Genzen, MD, PhD, chief medical officer and senior director of governmental affairs, on Wednesday, November 29, at 11 a.m. MST for a conversation about the FDA’s proposed rule to regulate laboratory-developed tests (LDTs) as medical devices. He’ll address patient safety, test availability, and the impact on innovation. ARUP’s compliance officer, Jonathan Carr, JD, will moderate a Q&A during the webinar.
December 4, 2023, is the deadline for public comment on the proposed rule.
Jonathan Genzen, MD, PhD
Chief Medical Officer and
Senior Director of
Governmental Affairs
Jonathan Carr, JD
Compliance Officer
Submit Questions in Advance
If adopted as proposed, FDA regulation of LDTs as medical devices will have widespread consequences for patient care, diagnostic innovation, and the economics of laboratory medicine. Help us shape the conversation to address your main concerns by submitting questions in advance.
To register and see additional educational resources, including how you can submit a comment, please visit our website.
LabMind Podcast
Listen to this related LabMind episode about why many tests that are critical to patient care—particularly in the areas of pediatrics, transplantation, and rare diseases—may become unavailable if the rule the FDA has proposed is enacted.
An Interview With Drs. Meghan Delaney and Eric Konnick: How FDA Restrictions on Laboratory-Developed Tests Will Harm Patients and Increase Costs
Listen to this episode
ARUP and Industry Partner Resources:
Association for Diagnostics & Laboratory Medicine Laboratories Podcast:
November 15, 2023: 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.
Letter to FDA Commissioner Robert M. Califf, MD, From 89 U.S. Laboratories and Industry Groups
October 21, 2023: Read the letter (a PDF available on our website).
American Clinical Laboratory Association Press Release
September 29, 2023: ACLA Opposes Unilateral FDA Action to Regulate Laboratory Developed Tests Under Medical Device Authority
ARUP Article on Results of Study Examining Use and Impact of LDTs on Patient Care
December 15, 2022: New ARUP Study Characterizes the Use and Importance of Laboratory-Developed Tests as Congress Considers the VALID Act
If you have additional questions, please contact Client Services and use keyword: Proposed FDA LDT
Contact ARUP Client Services
Call 800-522-2787 | online chat aruplab.com | email [email protected]