The U.S. Food and Drug Administration (FDA) has issued a notice to the Office of Information and Regulatory Affairs signaling its intent to rescind its final rule on laboratory developed tests (LDTs). This notice follows a U.S. District Court for the Eastern District of Texas ruling vacating the rule. We previously addressed that FDA issued the rule seeking to amend existing regulations to extend its authority to in vitro diagnostic products and tests, including LDTs.

The final rule would have amended the definition of “in vitro diagnostic products” to state that they are devices even “when the manufacturer of these products is a laboratory.” 89 Fed. Reg. 37286, 37287.

In March, the U.S. 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 M.D. See ACLA v. FDA, 4:24-cv-00479-SDJ (E.D. TX. Mar. 31, 2025). FDA expressed in its final rule that the federal Food, Drug and Cosmetic Act (FDCA) had always considered LDTs as medical devices, but FDA had previously declined to extend its enforcement discretion to them. Id. at 21. The court, however, agreed with plaintiffs that the rule exceeded FDA’s statutory authority because the FDCA’s text does not include in its purview “professional medical services” and LDTs are “professional medical services” that are “different from the tangible goods that FDA may regulate as ‘devices.’” Id. at 29-30.

The new rule would have affected approximately 79,114 existing tests and 1,181 existing laboratories and affect about 10,013 new tests yearly. Id. at 22. The rule would have gone into effect in May 2025 and required a phase-in schedule for the industry to comply with medical device requirements such as pre-market review and post-market compliance—and further resulted in significant costs for existing laboratory tests. Id. at 18, 21, 50.

Notably, FDA did not appeal the District Court’s ruling.

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.

For More Information

If you have any questions about this Alert, please contact Frederick R. Ball, Coleen W. Hill, Victoria (Tori) Hawekotte, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.