Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
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FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
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On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more
The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more
The order is in, and the LDT Final Rule is out. In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests...more
Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more