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The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards | King & Spalding

On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System...
International Organization For Standardization Drug Administration Federal Register Medical Devices Quality System Regulation Amendments Quality System Regulation

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