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Blood test in the lab

In a significant development for clinical laboratories, a federal district court has vacated the U.S. Food and Drug Administration (FDA)‘s final rule on laboratory-developed tests (LDTs). This ruling, issued on March 31, 2025, marks a major victory for the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), who contested the FDA’s authority to regulate LDTs.1

The FDA’s final rule, which was set to take effect on May 6, 2024, intended to classify LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This would have subjected LDTs to the same regulatory requirements as other in vitro diagnostic devices (IVDs), including premarket review, quality system regulation, and adverse event reporting. The FDA’s stance was that increased oversight was necessary due to the growing complexity of LDTs and the need to ensure their safety and effectiveness.2

However, the court ruled that the FDA’s regulation of LDTs exceeded its authority. The decision emphasized that LDTs are medical services provided by laboratories, which are already regulated under Clinical Laboratory Improvement Amendments (CLIA), not medical devices. This ruling prevents the FDA’s final rule from taking effect and alleviates the potential regulatory burden on laboratories offering LDTs.2

While this decision is a relief for many laboratories, it also leaves questions about the future regulation of LDTs. The FDA and Congress may still seek to impose new oversight measures, and an appeal of the court’s decision is possible.2 For now, laboratories can continue to develop and use LDTs without the additional regulatory requirements that the FDA’s final rule would have imposed.

At Orchard, we understand the importance of LDTs in providing innovative diagnostic solutions and supporting patient care. We remain committed to helping our customers navigate the evolving regulatory landscape and ensuring that our laboratory information systems support compliance with all applicable regulations. Stay tuned for further updates on this important issue and how it may impact your laboratory operations.

References

  1. Federal Court Vacates FDA Rule on Laboratory Developed Testing Services, Siding with ACLA. March 2025. https://www.acla.com/federal-court-vacates-fda-rule-on-laboratory-developed-testing-services-siding-with-acla/
  2. Klipp J, FDA Rule on LDTs is Dead…For Now. Laboratory Economics. April 2025.
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