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United States - Healthcare - FDA's New Rule Regulates Lab-Developed Tests Under FD&C Act

On April 29, 2024, the U.S. Food and Drug Administration announced a final rule that amends existing regulations to make explicit that in vitro diagnostic products and tests, including laboratory developed tests, are devices regulated under the Federal Food, Drug and Cosmetic Act.
Drug Administration Federal Food Device Amendments Beginning May Beginning November
Source: mondaq.com

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