FDA Reverses Final Rule Regulating Laboratory Developed Tests

The United States Food and Drug Administration (FDA) has officially rescinded its final rule proposing to regulate Laboratory Developed Tests (LDTs) as medical devices. On Sept. 19, 2025, FDA issued a new final rule reverting the text of the applicable device regulations to the version in-effect prior to the effective date of the May 2024 LDT rule….
By: Haynes Boone