Federal Administrative Agency abstains from filing an appeal against the court decree halting the final rule for Laboratory-Developed Tests (LDT)

Federal Administrative Agency abstains from filing an appeal against the court decree halting the final rule for Laboratory-Developed Tests (LDT)

## U.S. Court Decision Upholds Current Regulatory Framework for Lab Developed Tests (LDTs)

Following a recent U.S. District Court decision, the regulatory framework for Lab Developed Tests (LDTs) remains unchanged, with LDTs primarily subject to the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

The court's ruling, handed down in March 2025, vacated the Food and Drug Administration's (FDA) final rule that aimed to regulate LDTs as medical devices. The decision found that the FDA lacked statutory authority to regulate LDTs under the Federal Food, Drug, and Cosmetic Act (FDCA), determining that LDTs are professional medical services rather than manufactured products or devices.

### Key Aspects of the Current Framework:

1. **CLIA Oversight**: LDTs are primarily regulated under the CLIA framework, which is administered by the Centers for Medicare and Medicaid Services (CMS). CLIA requires laboratories to meet specific standards for quality control, personnel qualifications, and facility conditions.

2. **FDA Enforcement Discretion**: Historically, the FDA has exercised enforcement discretion regarding LDTs, not requiring them to meet FDA standards for premarket approval or clearance. This approach has been restored following the court's decision.

3. **Future Regulatory Environment**: Although the FDA's attempt to formalize its oversight over LDTs has been halted, the regulatory landscape is still evolving. The FDA may revisit this issue in the future with new rules or guidance, so stakeholders should remain vigilant for potential policy changes.

4. **Industry Recommendations**: The American College of Medical Genetics and Genomics (ACMG) has recommended updates to the CLIA framework to improve oversight without duplicating FDA regulations, emphasizing that existing systems are robust and can be strengthened without compromising access to critical tests.

The Association for Molecular Pathology (AMP) and the American Clinical Laboratory Association (ACLA) were among the groups that sued the FDA to block the rule, which would have expanded the agency's regulatory authority over LDTs. The FDA did not appeal the court's decision, confirming that LDTs are not medical devices subject to the agency's regulatory oversight.

In a statement, AMP President Jane Gibson said, "The court's decision should conclude the FDA's attempts to assert regulatory authority over LDTs." The ACLA also expressed anticipation for continued collaboration with policymakers to support patients, innovation, and clinical laboratories.

The court's favorable ruling was a significant victory for patients and healthcare providers across the country, according to AMP. However, analysts have suggested that a Democrat-led FDA may try to revive the issue in the future.

Sources: [1] Kelly, S. (2025, April 1). "Texas judge overturns FDA's lab developed test regulation, siding with industry groups." [online] Available at: https://www.reuters.com/article/us-usa-fda-ldts-idUSKCN2BQ26G [2] Kelly, S. (2025, April 16). "Recommended Reading: A judge blocked the FDA's plan to regulate LDTs. What now?" [online] Available at: https://www.statnews.com/2025/04/16/recommended-reading-a-judge-blocked-the-fdas-plan-to-regulate-ldts-what-now/ [3] "purchase licensing rights Legal, Diagnostics" [online] Available at: https://www.jdsupra.com/legalnews/fda-decision-not-to-appeal-court-ruling-8863152/

1. The current regulatory framework for Lab Developed Tests (LDTs) primarily adheres to the Clinical Laboratory Improvement Amendments (CLIA) of 1988, while the FDA's enforcement discretion allows for CLIA-regulated testing without requiring premarket approval or clearance.
2. The key aspects of this framework include CLIA oversight, as laboratories must meet quality control, personnel qualifications, and facility conditions standards, and FDA enforcement discretion, where LDTs are not subject to FDA regulations.
3. While the court's decision vacated the FDA's final rule that aimed to regulate LDTs as medical devices, the regulatory landscape may still evolve in the future, as the FDA might propose new rules or guidance.
4. Stakeholders in the medtech industry, such as the American College of Medical Genetics and Genomics (ACMG), recommend updates to the CLIA framework, emphasizing a need to strengthen existing systems without compromising access to critical tests.
5. Following the court's decision, the Food and Drug Administration (FDA) did not appeal, confirming that LDTs are not considered medical devices subject to FDA regulatory oversight.
6. Analysts predict that a Democrat-led FDA may attempt to address LDT regulation in the future, potentially reviving the issue that was blocked by the court's favorable ruling.
7. The Association for Molecular Pathology (AMP) and the American Clinical Laboratory Association (ACLA) were among the groups that filed a lawsuit to prevent the FDA's regulation changes, citing the potential harm to patients, innovation, and clinical laboratories.
8. Lastly, industry news outlets reported that healthcare providers and patients across the country welcomed the court's decision, viewing it as a significant victory for health-and-wellness and medical-conditions diagnosis, while stressing the importance of maintaining a robust and adaptable regulatory environment in the medtech industry and healthcare financing sector.

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