Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests


On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests (“LDTs”) under the Federal Food, Drug and Cosmetic Act (“FDCA”). As detailed in our prior analysis (here), the final rule amended the FDA’s existing regulations to make explicit the agency’s interpretation that LDTs are “devices” under the FDCA, and established a five-stage plan to phaseout the agency’s current general policy of “enforcement discretion” with respect to LDTs.

With the final rule’s July 5 effective date looming, two entities—a trade association and a laboratory—filed suit in federal court to overturn the final rule. In this Insight, we briefly summarize the legal theories advanced in the lawsuit and likely next steps.

Read the full alert here.