What You Need to Know about the FDA's New LDT Regulations

Join us on May 30 to discuss what steps clinical lab leaders will need to take to ensure they are prepared for the FDA's new LDTs rule

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Today's Clinical Lab
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Today’s Clinical Lab is a reader-centric publication that keeps clinical professionals up to date with today’s rapidly changing lab industry with in-depth and timely editorial content and resources, including clinical industry news and insights into the latest trends, technologies, and techniques in the clinical lab.

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Published:May 03, 2024
|2 min read


Photo portrait of Shannon Bennett

Shannon Bennett, Director of Regulatory Affairs, Department of Laboratory Medicine and Pathology, Mayo Clinic

          Photo portrait of Julie Ballard

Julie Ballard, Principal, Carrot Clinical

When: Thursday, May 30, 2024 at 1:00 PM ET

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Regulation of laboratory-developed tests (LDTs) has turned into a flashpoint for the diagnostic lab industry in 2024.

After years of debate and buildup about whether LDTs should be considered in vitro diagnostics (IVDs), on April, the U.S. Food and Drug Administration (FDA) released a final rule on the matter. Now, many medical labs that develop LDTs are on a countdown to major changes as the rule begins a phase-out period of prior enforcement discretion that kept LDT regulation less complex.

Join Today’s Clinical Lab and G2 Intelligence for a free webinar on May 30 at 1:00 p.m. ET that will explain critical points of the FDA’s LDT regulation.

In the webinar, “Key Things Labs Need to Know about the FDA’s Final LDTs Rule”, speakers Shannon Bennett and Julie Ballard will focus on immediately steps labs leaders should consider in the wake of the FDA’s action.

Our experts will present the most important aspects of the final rule and offer compliance strategies to prepare for longer-term requirements.

Participants in the webinar will be able to ask questions to our experts about the FDA’s LDT rule. You can also submit questions in advance by registering now for this informative event.

REGISTER FOR FREE 


Photo of the Today's Clinical Lab logo
Today's Clinical Lab

Today’s Clinical Lab is a reader-centric publication that keeps clinical professionals up to date with today’s rapidly changing lab industry with in-depth and timely editorial content and resources, including clinical industry news and insights into the latest trends, technologies, and techniques in the clinical lab.


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RegulationsLab Developed TestsManagementFDA
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What You Need to Know about the FDA's New LDT Regulations
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