Regarding the ongoing lawsuit challenging the U.S. Food and Drug Administration (FDA) regulation of laboratory-developed tests (LDTs) as medical devices, Judge Sean D. Jordan of the United States District Court, Eastern District of Texas ruled the FDA does not have the legal authority to regulate lab-developed tests. This ruling was signed on March 31, 2025.
The context of the case was that the American Clinical Laboratory Association (ACLA) v. U.S. Food and Drug Administration (FDA) challenged the FDA’s authority to regulate laboratory-developed test (LDTs), tests developed and performed within a single laboratory, under the same framework as medical devices. Historically, LDTs have been regulated under the Clinical Laboratory Improvement Amendments (CLIA), overseen by the Centers for Medicare & Medicaid Services (CMS), rather than the FDA. The ACLA argues that the FDA lacks statutory authority to regulate LDTs as medical devices, while the FDA has pushed for increased oversight, citing patient safety concerns.
The conclusion that LDT services are not “devices” under § 321(h) was confirmed and that “unlike physical products, professional services are not ‘manufactured.’” In summary, the Fifth Circuit has made clear that district courts should generally “nullify and revoke” illegal agency action.
Read ACLA’s full lawsuit.
Read the Final Judgment.