News

Federal court vacates FDA Laboratory Developed Test rule

01 April 2025

Yesterday, the U.S. District Court for the Eastern District of Texas vacated the U.S. Food and Drug Administration’s 2024 rule that aimed to regulate laboratory-developed tests (LDTs) as medical devices, deciding it is outside the agency's statutory authority.

In the combined cases of American Clinical Laboratory Association v. FDA and Association for Molecular Pathology v. FDA, the District Court found that LDTs are “professional services” subject to the existing regulatory framework under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), not "devices" under the Food, Drug, and Cosmetic Act (FDCA).

Stay tuned for detailed analysis on how this ruling may impact the future of diagnostic testing and laboratory operations. If you have any questions about regulations related to in vitro diagnostics, you may contact any of the authors of this alert or the Hogan Lovells attorney with whom you generally work.

Authored by Janice Hogan, Randy Prebula, Lowell Zeta, Blake Wilson, and Erkang Ai.