Summary of FDA LDT Court Ruling and Implications

Background of the Ruling

On March 31, 2025, a federal judge vacated the FDA’s final rule that would have subjected laboratory-developed tests (LDTs) to the same regulatory framework as in vitro diagnostic (IVD) devices. The court found that the FDA lacks the statutory authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate LDTs as medical devices.

This decision stems from a lawsuit brought by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), who argued that the FDA exceeded its authority by attempting to regulate LDTs without Congressional approval.

Immediate Implications

◾ The FDA’s final rule issued in May 2024 is now nullified, and the agency cannot enforce the new LDT regulations.

◾ LDTs will continue to operate under the historical model of enforcement discretion, meaning the FDA will not actively regulate these tests.

◾ Laboratories do not need to take immediate compliance actions related to the now-vacated final rule.

Short-Term Implications for Clinical Labs

• Labs can continue developing and offering LDTs under CLIA and state regulations, without needing FDA premarket review or compliance with device-specific labeling and manufacturing requirements.
• Labs should remain vigilant and closely monitor developments, as further legal or legislative changes may follow.
• Any FDA actions requiring registration, adverse event reporting, or quality system compliance under the vacated rule are no longer enforceable.

 FDA’s Options Moving Forward

1. Appeal the Decision

• • The FDA can file an appeal to the U.S. Court of Appeals, seeking to overturn the district court’s decision.
  • If successful, this could reinstate the agency’s rule and enforcement powers.

2. Request Legislative Authority

• • Congress could pass new legislation (e.g., the VALID Act) to explicitly grant the FDA regulatory authority over LDTs.
  • The ruling may pressure lawmakers to move forward with a legislative framework to address regulatory gaps.

3. Shift to Revised Guidance or Enforcement Discretion Policies

• • While the rule is vacated, the FDA may attempt to issue new guidance or policy statements to increase oversight indirectly, though its authority remains limited unless Congress acts.

Likely or Possible Paths Ahead

• Near-term status quo: LDTs remain regulated under CLIA and state law, with no FDA oversight unless voluntarily adopted by labs.
• Legal appeals: The FDA is likely to appeal, but the case could take months or years to resolve.
• Push for legislation: The ruling may renew legislative interest in the VALID Act or similar proposals to create a modern framework for test oversight.
• Industry responses: Labs should stay engaged with industry groups like ACLA and AMP for updates and advocacy.

👉Recommended Actions for Labs

• Stay informed on legal developments and potential FDA appeals.
• Document test validation processes and maintain strong internal quality systems to ensure patient safety and compliance with CLIA standards. The Quasar Phase I kit can still be used to maintain compliance. Quasar is actively updating its kit contents to ensure ongoing compliance with both CLIA and COLA requirements.
• If FDA regulation becomes a future reality, having robust systems now will ease any transition.

Here are all the relevant links and news sites covering the latest FDA ruling:

Federal Court Vacates FDA Rule on Laboratory Developed Testing Services, Siding with ACLA – American Clinical Laboratory Association

March 31, 2025 | College of American Pathologists

Texas Court Vacates Food and Drug Administration’s LDT Final Rule