An ARUP expert will answer questions about a proposed FDA rule to regulate laboratory-developed tests (LDTs) as medical devices, which will potentially limit patient access to essential medical care.
December 4, 2023, is the deadline for public comment on the proposed rule.
See ARUP's public comment here.
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 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.
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.
ARUP and Industry Partner Resources
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.
November 4, 2023: 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.
October 21, 2023: Read the letter.