FDA Formally Vacates LDT Final Rule

The Food and Drug Administration has formally vacated its May 6, 2024, final rule establishing a regulatory framework for laboratory-developed tests (LDTs). On Sept. 19, 2025, the agency issued a final rule restoring the regulatory text in 21 CFR 809.3(a) to what it was before the May 2024 rule took effect.

This vacatur follows a ruling by the U.S. District Court for the Eastern District of Texas, which found that the final rule exceeded the agency’s authority and was therefore unlawful. FDA declined to appeal the ruling.

AABB previously joined a coalition of health care organizations in opposing the final rule, which could have imposed financial burdens on laboratories, stifled innovation and compromised patient care.