Possible Regulation of Laboratory Developed Tests (LDTs) through Indirect Methods by the FDA

Possible Regulation of Laboratory Developed Tests (LDTs) through Indirect Methods by the FDA

The FDA's attempt to expand its jurisdiction over Laboratory Developed Tests (LDTs) has been temporarily halted, following a court ruling that found the FDA exceeded its statutory authority. The federal court's decision vacated the FDA’s 2024 Final Rule, effectively halting the attempt to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA) for now.

However, the FDA may still pursue other avenues to assert authority over LDTs in the future. These include issuing revised or narrower regulations or guidance, targeted enforcement actions, seeking congressional legislation, and collaboration with other federal agencies or professional organizations.

One example of the FDA using its authority over devices can be seen in a recent warning letter to Agena Bioscience, similar to the one sent to DRG Instruments. The letter focused on evidence of unapproved device violations for an assay that was labeled for research use only but appeared to be intended for clinical diagnostic use instead.

The court ruling does not preclude the agency from pursuing more incremental, strategic, or congressional avenues to assert oversight over LDTs in the future. Companies offering LDTs should remain alert to evolving policy and enforcement trends.

Another ambiguity in the definition of LDTs is what it means to be a single clinical laboratory, especially for large corporations with multiple lab locations. Another lingering question is the FDA's approach to the regulation of companion diagnostic tests and software used with LDTs.

The Association for Molecular Pathology proposes updating the Clinical Laboratories Improvement Amendments (CLIA) regulations through Congress rather than increasing FDA authority. The aim is to expand CLIA to ensure high-quality testing is maintained.

The timing of the DRG warning letter and the FDA inspection that led to it occurred before the district court's LDT decision and therefore does not appear to be a direct response to the order.

As the dust settles, it is clear that this is not the end of the discussion about how LDTs will fit into the FDA regulatory framework. The FDA may still look to more clearly define what constitutes a laboratory developed test, and the industry awaits further developments with interest.

1. The Federal Drug Administration (FDA) may look to revise or narrow its regulations for Laboratory Developed Tests (LDTs) after a court ruling temporarily halted its attempt to regulate them as medical devices.
2. The federal court's decision does not prohibit the FDA from seeking congressional legislation or collaborating with other agencies to assert authority over LDTs.
3. Companies that offer LDTs should be aware of the evolving policy and enforcement trends in the medtech industry.
4. The Association for Molecular Pathology suggests updating the Clinical Laboratories Improvement Amendments (CLIA) regulations through Congress to ensure high-quality testing, rather than increasing FDA authority.
5. News about the FDA's regulations on LDTs, including its enforcement actions, can have a significant impact on the health-and-wellness industry and the AI, diagnostics, and medical-conditions sectors.
6. Another question regarding LDTs is how the FDA will approach the regulation of companion diagnostic tests and software used with these tests.
7. The FDA's jurisdiction over devices, as demonstrated by the warning letter to Agena Bioscience, involves ensuring compliance with regulations regarding clinical diagnostic use.

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