The agency signals intent to withdraw final rule extending regulatory authority to LDTs following federal court ruling that vacated the regulation.
The US Food and Drug Administration (FDA) has issued a notice to the Office of Information and Regulatory Affairs indicating its intent to rescind its final rule on laboratory developed tests (LDTs), following a US District Court ruling that vacated the regulation.
The final rule, published in May 2024, would have amended the definition of “in vitro diagnostic products” to clarify that they are devices even “when the manufacturer of these products is a laboratory.” The regulation was intended to extend FDA’s regulatory authority to LDTs, which had previously operated under the agency’s enforcement discretion.
In March 2025, the US District Court for the Eastern District of Texas vacated the rule in a consolidated case brought by the American Clinical Laboratory Association, Association for Molecular Pathology, HealthTrackRX Indiana Inc, HealthTrackRX Inc, and Michael Laposata, MD. The court ruled that the regulation exceeded FDA’s statutory authority under the Federal Food, Drug, and Cosmetic Act (FDCA).
Court Finds Rule Exceeds Statutory Authority
The court agreed with plaintiffs that the rule exceeded FDA’s statutory authority because the FDCA’s text does not include “professional medical services” within its regulatory scope, according to an alert from Duane Morris LLC, which further notes that the court determined that LDTs constitute “professional medical services” that are “different from the tangible goods that FDA may regulate as ‘devices.'”
While FDA expressed in its final rule that the FDCA had always considered LDTs as medical devices, the agency had previously declined to extend its enforcement authority to them. Notably, FDA did not appeal the district court’s ruling.
The rescinded rule would have affected approximately 79,114 existing tests and 1,181 existing laboratories, with an estimated impact on about 10,013 new tests annually, notes the Duane Morris LLC alert. The regulation was scheduled to take effect in May 2025 with a phased implementation schedule requiring laboratories to comply with medical device requirements including premarket review and post-market compliance.
“This ruling and rule recission have returned laboratories developing LDTs for use within a single clinical laboratory to status quo, though laboratories should remain vigilant about any impending attempts to further regulate their products, whether by FDA or by Congress,” according to the Duane Morris LLC alert.
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