FDA Formally Rescinds the LDT Final Rule Following Defeat in Court

On August 6, 2025, the Office of Information and Regulatory Affairs (OIRA) published a notice that FDA has rescinded the Laboratory Developed Test (LDT) Final Rule that was vacated earlier this year by the U.S. District Court for the Eastern District of Texas. The rescission is pending regulatory review by OIRA pursuant to EO 12866.

Although the OIRA notice provides few details on the nature of the rescission, it will almost certainly entail the removal of the nine words the LDT Final Rule added to the definition of “in vitro diagnostic products” in 21 C.F.R. § 809.3, which stated that IVD products are FDA-regulated devices “including when the manufacturer of these products is a laboratory.”

Because the government chose not to appeal the decision vacating the LDT Final Rule, the rescission is largely a formality, as the added regulatory language is already a dead letter. FDA could be trying to claim credit for rescinding the rule as part of the general deregulatory push of this administration (see e.g., EO 14192, which requires that Federal agencies eliminate 10 regulations, guidance or similar materials for each new regulation). Whatever the reason, rescinding the LDT Final Rule further punctuates the end of this chapter in FDA’s long sought effort to claim jurisdiction over LDTs.