LUGPA Policy Alert: Federal Court Strikes Down FDA Rule on Laboratory-Developed Tests (LDTs) 

April 2025 

On March 31, 2025, the U.S. District Court for the Eastern District of Texas vacated the FDA’s final rule that sought to regulate Laboratory-Developed Tests (LDTs) as medical devices under the Food, Drug, and Cosmetic Act (FDCA). The court ruled that the FDA exceeded its authority, affirming that Congress intended LDTs to be regulated under the Clinical Laboratory Improvement Amendments (CLIA), which is overseen by the Centers for Medicare & Medicaid Services (CMS).

This decision represents a major victory for clinical laboratories, academic medical centers, and healthcare providers, ensuring that access to innovative, high-quality diagnostic tests remains protected. The ruling halts regulatory expansion that could have increased costs, stifled innovation, and restricted patient access to essential diagnostic services.

Key Takeaways from the Court’s Decision

FDA Overreach Rejected: The court determined that the FDA does not have the statutory authority to regulate LDTs as medical devices. Instead, CLIA remains the governing framework, providing standards for quality and accuracy while allowing flexibility for innovation in laboratory testing.

Patient Access and Innovation Preserved: Had the FDA’s rule been implemented, it would have imposed significant regulatory burdens on laboratories, particularly smaller facilities and those within academic medical centers. The ruling prevents:

• Unnecessary compliance costs that could have forced labs to discontinue critical tests.
• Delays in diagnostic innovation, ensuring that new, patient-specific tests can be developed without excessive red tape.
• Reduced access to specialized testing, particularly for rare diseases and personalized medicine.

The court’s decision is expected to face further legal and legislative challenges, with stakeholders on both sides weighing potential next steps. While the ruling is a setback for the FDA’s efforts to expand its oversight, the agency may seek appeal options or push for new legislation granting it clearer authority over LDTs.

LUGPA’s Position and Advocacy Efforts

LUGPA has long advocated for regulatory policies that protect patient access to high-quality, innovative diagnostic tests without imposing unnecessary barriers on laboratories and healthcare providers. This ruling aligns with LUGPA’s position that:

• Regulatory policies should promote innovation and expand patient access rather than creating burdens that limit diagnostic advancements.
• Congress must pursue balanced solutions that ensure both patient safety and laboratory autonomy in developing essential tests.

LUGPA will continue to engage with policymakers, regulatory agencies, and industry leaders to ensure that any future regulatory changes support patient-centered care, innovation, and provider flexibility.

For more information, visit the FDA’s official page on LDTs.