A federal judge in Texas has invalidated the Food and Drug
Administration’s recent regulation of laboratory developed tests (LDTs), delivering a significant win for clinical laboratories that opposed the measure. The ruling, issued Monday 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.
The laboratory industry 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 to medical care. Industry groups maintained that LDTs are already effectively regulated under existing Clinical Laboratory Improvement Amendments (CLIA) oversight managed by the Centers for Medicare and Medicaid Services.
The American Clinical Laboratory Association (ACLA), which initiated the legal challenge against the FDA, confirmed that the rule and its associated compliance deadlines are no longer valid following the court’s decision. ACLA President Susan Van Meter celebrated the ruling as a victory for preserving patient access to essential testing services and eliminating burdensome regulations that would have undermined the nation’s clinical laboratory system.
The now-overturned regulation was scheduled to begin implementation on May 6, requiring labs to comply with medical device reporting requirements, correction and removal procedures, and complaint file maintenance. The rule would have continued to phase in additional requirements over a four-year period.
In his opinion, Judge Jordan identified two fundamental flaws in the FDA’s approach. First, he determined that the agency’s attempt to regulate laboratory testing services as medical devices exceeded its authority under the Federal Food, Drug, and Cosmetic Act of 1938. Jordan emphasized that only Congress has the power to modify the act’s text. Second, he rejected the FDA’s broad interpretation of the term “device,” noting that such an expansive definition would
inappropriately extend FDA oversight to all surgical procedures and physical examinations utilizing medical devices.
The Association for Molecular Pathology, another plaintiff in the case, praised the court’s decision through its president, Jane Gibson, who stated that the ruling would prevent billions in additional healthcare costs and protect hundreds of millions of Americans’ access to high-quality care. The association advocates for clarifying existing CLIA regulations as the most effective way to ensure continued development of accurate LDT procedures and proper test result interpretation.
AdvaMedDx Executive Director Zach Rothstein, while still reviewing the decision, expressed concern about maintaining separate oversight systems for tests serving identical clinical purposes, calling it inefficient and potentially detrimental to public health. He emphasized that the court’s ruling underscores the need for
Congressional action.
The FDA’s regulatory effort emerged in the absence of successful legislation, specifically the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which Congress had failed to pass over several years. The VALID Act would have amended the FDCA to establish a clear regulatory framework for LDTs. Without such legislation, the FDA attempted to expand its authority to ensure the safety and effectiveness of new diagnostic tests, an effort now blocked by the court’s ruling.
The laboratory industry maintains that the existing CLIA framework provides sufficient oversight for LDTs, and that additional FDA regulation would create unnecessary barriers to test development and patient care. The court’s decision effectively maintains the status quo of laboratory test regulation under CLIA, while leaving the door open for potential future legislative action to address the regulatory framework for diagnostic testing.
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