On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6, 2024, final rule (the LDT Rule). The rule would have subjected laboratory-developed tests (LDTs) to regulation as in vitro diagnostic products (IVDs), which the FDA asserts are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). The regulation of LDTs under the LDT Rule (i.e., the phaseout of FDA’s enforcement discretion approach to LDTs) was scheduled to commence in May 2025. The court’s ruling prevents the LDT Rule from taking effect.
While it is unclear if FDA will appeal the decision, its notice of appeal is due on May 30, 2025. The court’s ruling does not impact other regulatory requirements for LDTs, and clinical laboratories developing LDTs will still need to comply with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), including establishing performance specifications, and obtain any relevant state approvals.
IVDs are reagents, instruments, and systems intended for use in the diagnosis of diseases or other conditions to cure, mitigate, treat, or prevent disease or its sequelae. The LDT Rule amended the definition of IVDs to clarify that they include products manufactured by a laboratory in order to phase out FDA’s general enforcement discretion approach for LDTs. The American Clinical Laboratory Association and HealthTrackRx, as well as the Association for Molecular Pathology, filed lawsuits challenging the validity of the LDT Rule, arguing FDA lacked the authority to regulate LDTs as devices.
The court determined that LDTs are professional medical services that do not fall under the definition of a “device” under the FDCA and that Congress had vested regulation of LDTs with the U.S. Centers for Medicare & Medicaid Services under CLIA rather than with FDA. Accordingly, the court ruled that FDA lacked jurisdiction under the FDCA to regulate LDTs and vacated the LDT Rule.
In reaching its decision, the court addressed the U.S. Supreme Court’s decision in Loper Bright, which overruled Chevron deference, and focused on its obligation to exercise its “independent judgment in deciding whether an agency has acted within its statutory authority.” In analyzing the LDT Rule, the court effectively treated the methodology that laboratory personnel use to evaluate samples utilizing physical products, such as reagents and instruments, as “professional medical services,” and on that basis concluded that LDTs are not devices under the FDCA. Fundamentally, the court held that the FDCA only gives FDA authority to regulate drugs, devices, and other physical “articles,” not intangible processes or services.
This position is in tension with the framework adopted by FDA that constrains regulated devices to their indications for use, requires manufacturers to develop instructions for use, and prohibits off-label promotion (e.g., promoting off-label “methodologies” for using the device). It remains to be seen whether the court’s logic in this case will be used to challenge FDA’s jurisdiction over other regulated devices or products that could be deemed intangible processes or services outside the scope of the FDCA, or whether FDA will appeal the decision. Even if FDA does not appeal, it could take the position that certain types of laboratory tests are distinguishable from the LDTs addressed by the court and therefore remain subject to FDA jurisdiction. Accordingly, laboratories should exercise caution if they market tests that bear the hallmarks of more traditionally regulated IVDs, such as “test kit” packages.
McGuireWoods’ life sciences regulatory and compliance team helps clients navigate the evolving landscape of life sciences laws and regulations. For assistance addressing the regulation of LDTs, IVDs, or other FDA-regulated products, please contact one of the authors of this article.