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Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

Summary by FDA Law Blog
By Allyson B. Mullen & Jeffrey N. Gibbs —The multi-decade battle over FDA’s power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week.  On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology’s (AMP)[1] lawsuit against the Department of Health and Human Services.  ACLA and AMP are b…
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America's Blood CentersAmerica's Blood Centers

Protecting Patient Care: Exempting Blood Center LDTs from Regulation

This one pager outlines the implications of the FDA’s May 2024 final rule on in vitro diagnostic products (IVDs), focusing on its impact on blood centers and laboratory developed tests (LDTs). It provides an overview of the current regulatory framework for blood centers, explains the critical role of LDTs in life-saving procedures, and highlights concerns about the new regulation’s potential to delay patient care and increase costs. It also incl…

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FDA Law BlogFDA Law Blog

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

By Allyson B. Mullen & Jeffrey N. Gibbs —The multi-decade battle over FDA’s power to regulate Laboratory Developed Tests (LDTs) had its day in court earlier this week.  On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology’s (AMP)[1] lawsuit against the Department of Health and Human Services.  ACLA and AMP are b…

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FDA Law Blog broke the news in on Thursday, February 20, 2025.
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