District Court Overturns FDA’s LDT Rule: What the Ruling Means for Clinical Labs Now
Under the district court’s vacatur, the LDT final rule and its compliance deadlines are no longer in effect and cannot be enforced
Christine P. Bump, principal and founder of Penn Avenue Law & Policy, is an insightful regulatory attorney with two decades of experience developing and implementing FDA strategies for devices, diagnostics, digital health platforms, and genetic and genomic tests. She advises laboratories, large corporations, and emerging companies with an awareness and understanding of their business and strategic goals. Christine has served as regulatory counsel for a national diagnostic coalition, written several articles, and presented at numerous industry conferences. Before starting her firm, she practiced at Hyman, Phelps, & McNamara, P.C. and in the Life Sciences group at Goodwin. Christine earned a B.A. from Sweet Briar College, an M.P.H. from Emory University’s Rollins School of Public Health, and a J.D. from Emory University School of Law.
ViewFull ProfileLearn about ourEditorial Policies.
On March 31, 2025, the U.S. District Court for the Eastern District of Texas vacated and set aside the Food and Drug Administration’s (FDA’s) final rule that defined and regulated laboratory-developed tests (LDTs) as devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
What does the decision mean?
Under the district court’s vacatur, the LDT final rule and its compliance deadlines are no longer in effect and cannot be enforced. The court determined the final rule exceeds the FDA’s statutory authority because “devices” are limited to tangible, physical products distributed in interstate commerce. LDTs are laboratory test services, which according to the court, are “qualitatively and categorically different.”
Moreover, the timelines and legislative histories of the FDCA and Clinical Laboratory Improvement Amendments (CLIA) demonstrate Congress viewed devices and laboratory testing as “distinct problems requiring different regulatory solutions.” Thus, the FDA’s expansion of its device jurisdiction over LDTs “is foreclosed by the text, structure, and history” of the FDCA and CLIA, and violates the Administrative Procedures Act.
What could happen next?
The government has 60 days from the district court’s judgment to file a notice of appeal. It is unclear whether this administration will appeal, or if an appeal would include a request for a stay. If granted, a stay would suspend the judgment while the appeal is reviewed by the U.S. Court of Appeals for the Fifth Circuit, and could temporarily reinstate the LDT final rule compliance deadlines. Without a stay, these dates would remain void.
The district court’s vacatur remanded the “matter” of the final rule to the Secretary of Health and Human Services (HHS). FDA could therefore promulgate a new rule to regulate LDTs, but the court’s decision makes this difficult. The only obvious mechanism for the FDA to regulate LDTs is through its device jurisdiction. The FDA can also undertake rulemaking to formally rescind the LDT final rule, or appear to do nothing for now.
Appropriate regulation of LDTs is an issue that must be resolved by Congress. That may be through a modernization of CLIA, which addresses advancements in laboratory testing, or a new regulatory framework for laboratory tests. HHS and/or the FDA is likely to work with Congress on such legislation.
What should clinical laboratories do now?
The court’s decision does not change other aspects of the FDA’s device jurisdiction. Though LDTs are not devices, components and instruments used to develop and perform these tests still fall under the agency’s authority.
For example, analyte specific reagents (ASRs) remain devices, and research use only (RUO) components and instruments must be used consistent with their labeling. Laboratories must therefore remain compliant with applicable FDA regulations and requirements.
Laboratories should follow judicial and legislative developments, and should consider engaging with other stakeholders to advance appropriate legislation for LDTs or clinical laboratory tests generally. In addition to actions the government may take in response to the district court’s ruling, there are many open questions and potential for future regulatory and legal challenges.