Public Health Implications of Legal Challenges to the FDA's Regulation of Laboratory-Developed Tests.

Abstract

Importance: Laboratory-developed tests (LDTs) refer to in vitro diagnostics developed and used by individual laboratories. LDTs are widely used in modern medicine, with their results informing over 70% of clinical decisions. The US Food and Drug Administration (FDA) has historically claimed regulatory authority over LDTs and, in 2024, finalized new regulations to strengthen oversight of these products. However, the FDA's rulemaking was vacated in the 2025 court case American Clinical Laboratory Association et al v FDA et al, a decision that has carried substantial implications for public health.

Observations: The FDA has possessed oversight of in vitro diagnostic tests, including LDTs, since the US Congress passed the Medical Device Amendments Act of 1976. Due to their limited use, the FDA initially exempted LDTs from formal requirements for premarket clinical testing and regulatory review. These regulatory flexibilities enabled substantial innovation in diagnostic technology, enabling the development of LDTs for applications including routine clinical care, complex molecular testing, and rapid response during public health emergencies. However, the exponential growth of LDTs in clinical practice despite little to no clinical evidence of safety and effectiveness has raised public health concerns from the FDA and Congress, with subsequent investigations identifying substantial issues related to test quality and performance. These findings motivated the FDA to issue a new rule expanding its risk-based approach to LDT regulation that was subsequently challenged in the US District Court for the Eastern District of Texas by the American Clinical Laboratory Association and the Association of Molecular Pathology. The court ruled in favor of the plaintiffs and moved to vacate the FDA's LDT rule, asserting that LDTs constituted services, not products, and were therefore beyond the scope of the FDA's medical device authorities. Applying the Supreme Court's recent decision to overturn the Chevron doctrine that deferred to agency interpretation in implementing statute, the court also ruled that the FDA could not regulate LDTs without the express authorization of Congress.

Conclusions and relevance: The case of LDTs illustrates the challenges the FDA faces when adapting regulatory frameworks in response to emerging health technologies. The outcomes of recent reforms and litigation carry substantial public health implications for both diagnostic technologies and the FDA's broader regulatory remit.