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Regulatory Requirements Federal Food Drug and Cosmetic Act (FFDCA) International Standards

King & Spalding

FDA Aligns U.S. Medical Device Quality System Regulation with International Standards

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On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) and harmonizing them with...more

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