In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s decades-long policy of enforcement discretion and bring LDTs under the same regulatory framework as other in vitro diagnostics (IVDs). The move was met with controversy, and many industry stakeholders predicted litigation.
They were right.
Fast forward to May 2025: a federal court in Texas vacated the rule, finding that FDA lacked the statutory authority to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). When FDA declined to appeal the ruling, the rule was officially nullified. With that, FDA’s effort to bring LDTs under formal oversight has been halted for now, leaving the industry back in a familiar but uncertain space.
What It Means for the Industry
For now, the FDA’s historical approach remains in effect. CLIA-certified labs can continue to offer LDTs without FDA clearance or approval. However, the regulatory landscape is still evolving.
Key takeaways:
- Premarket Requirements Are Off the Table, For Now
The court’s decision prevents FDA from mandating 510(k), PMA, or De Novo submissions for LDTs based on the now-vacated rule.
- Regulatory Discretion Still Applies
FDA maintains authority to intervene when LDTs present safety concerns, are improperly promoted, or otherwise fall outside the bounds of CLIA oversight.
- Future Rulemaking or Legislation Is Possible
While the agency opted not to appeal, it may regroup and consider narrower rulemaking or ask Congress to affirm its authority over LDTs through legislation.
- Compliance Pressure Isn’t Gone
Even in the absence of FDA enforcement, labs still face scrutiny from payers, CLIA, and state regulators. Demonstrating clinical validity and appropriate test performance remains critical, especially for tests used in high-stakes patient care.
Our Take
The court’s ruling marks a significant moment in the evolving regulatory landscape for LDTs, but it’s far from the final word. FDA’s decision not to appeal may reflect a tactical recalibration, not a full retreat. Companies developing or offering LDTs should continue to assess their regulatory exposure, anticipate potential policy shifts, and remain prepared for renewed FDA action, whether in the form of revised rules, new guidance, or targeted enforcement. According to Amanda Johnston,
"The court’s decision doesn’t grant a free pass. For LDT developers, now is a good time to reassess your regulatory strategy. With the possibility of future FDA action still on the table, aligning with best practices in regulatory and compliance documentation can help ensure you’re prepared for whatever direction policy may take.”
