A federal court in Texas has invalidated the Food and Drug
Administration’s recent regulation aimed at overseeing laboratory developed tests (LDTs) as medical devices, delivering a significant win for clinical laboratories that opposed the measure.
The ruling, issued by U.S. District Court Judge Sean Jordan in the Eastern District of Texas, completely vacated the FDA’s final rule and directed the matter back to Health and Human Services Secretary Robert F. Kennedy Jr. for review.
Clinical laboratory organizations had strongly contested the FDA’s regulation, contending it would impede the development of crucial diagnostic tests and force laboratories to reduce their testing capabilities, ultimately limiting patient access. Industry groups maintained that LDTs are already effectively regulated under existing Centers for Medicare and Medicaid Services’ Clinical Laboratory Improvement Amendments (CLIA) framework.
Following the court’s decision, the American Clinical Laboratory Association (ACLA), which initiated the legal challenge, confirmed that the rule and its associated implementation deadlines are no longer valid. ACLA President Susan Van Meter celebrated the ruling as a win for preserving patient access to essential testing services and eliminating burdensome regulations that would have undermined the nation’s clinical laboratory system.
The FDA’s rule was scheduled to begin implementation on May 6, initially requiring laboratories to comply with medical device reporting requirements and maintain complaint records, with full implementation planned over a four-year period.
Judge Jordan’s opinion identified two fundamental flaws in the FDA’s approach. First, he determined that the agency’s attempt to expand its jurisdiction under the Federal Food, Drug, and Cosmetic Act of 1938 exceeded its statutory authority, emphasizing that such changes require congressional action. Second, the judge rejected the FDA’s broad interpretation of the term “device,” noting it would
inappropriately extend FDA oversight to all surgical procedures and physical examinations using devices.
The Association for Molecular Pathology, another plaintiff in the case, praised the court’s decision through its president, Jane Gibson, who emphasized that overturning the rule would prevent billions in additional healthcare costs and protect access to quality care for hundreds of millions of Americans.
The organization advocated for clarifying existing CLIA regulations as the most effective way to ensure continued development of accurate LDT procedures and proper interpretation of molecular test results.
AdvaMedDx Executive Director Zach Rothstein, while still reviewing the decision, expressed concern about maintaining separate oversight systems for tests serving the same clinical purposes, arguing it neither serves public health interests nor represents efficient resource utilization. He emphasized that the court’s ruling
underscores the need for congressional action.
The FDA’s regulatory effort came after years of congressional failure to pass the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which would have amended the FDCA to establish a clear regulatory framework for LDTs. This legislative void prompted the FDA’s attempt to expand its authority to ensure the safety and effectiveness of new diagnostic tests.
The ruling represents a significant setback for the FDA’s efforts to establish broader oversight of laboratory testing and highlights the ongoing debate over the appropriate regulatory framework for diagnostic testing in the United States. The decision also underscores the complex relationship between federal regulatory authority and healthcare industry innovation, particularly in the rapidly evolving field of clinical diagnostics.
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