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Expert Analysis

The Future Of Lab-Test Regs After FDA Rescinds Rule

By Justin Coen, Jeremiah Kelly and Laura Rich ( August 19, 2025, 4:54 PM EDT) -- On Aug. 6, the U.S. Food and Drug Administration rescinded its final rule on laboratory-developed tests. The development follows the U.S. District Court for the Eastern District of Texas' March 31 decision vacating the rule, holding in American Clinical Laboratory Association v. FDA that the agency lacked authority to regulate LDTs as medical devices under the Federal Food, Drug and Cosmetic Act.[1]...

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