The United States District Court for the Eastern District of Texas on March 31 ruled that the Food and Drug Administration (FDA) does not have authority to regulate laboratory-developed tests. This decision struck down a 2024 final rule that allowed the FDA to regulate most laboratory-developed tests (LDTs) as medical devices beginning in May 2025.
The court held that the statutory language in the agency’s rule unambiguously confirms that a “device” is a tangible, manufactured product, not a professional service, adding that, “laboratory services are professional medical services that are qualitatively and categorically different from the tangible goods that FDA may regulate as ‘devices.’”
The FDA’s 2024 rule clarified that in vitro diagnostic products (IVDs) are considered devices under the Federal Food, Drug, and Cosmetic Act, including when the IVD manufacturer is a laboratory. The rule had also finalized a phase-out of its general enforcement discretion approach for LDTs over the course of four years.
The decision heavily referenced the Supreme Court’s ruling in Loper Bright v. Raimondo, which ended the principle of Chevron deference obligating courts to defer to federal agencies’ judgments if their interpretation of law was reasonable, even if judges did not believe it was the best interpretation.
Clinical laboratories offering LDTs will not be required to comply with any phases of the final rule unless FDA successfully appeals the court’s ruling.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
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