Explore the response to the FDA's Laboratory Developed Tests, LDTs, final rule, including industry concessions, legal challenges, and legislative reactions.
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape.
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for.
On May 6, 2024, the U.S. Food and Drug Administration issued its final rule significantly modifying FDA's approach to oversight of laboratory developed tests.