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FDA Aligns U.S. Medical Device Quality System Regulation with International Standards | King & Spalding - Vimarsana News

FDA Aligns U.S. Medical Device Quality System Regulation with International Standards | King & Spalding

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...

Harmonization Is Key: FDA's Proposed Rule Seeks To Revamp Medical Device Quality System Regulation - Food, Drugs, Healthcare, Life Sciences - Vimarsana News

Harmonization Is Key: FDA's Proposed Rule Seeks To Revamp Medical Device Quality System Regulation - Food, Drugs, Healthcare, Life Sciences

On February 23, 2022, FDA published a proposed regulation, requesting public comment, to amend the medical device current good manufacturing practice requirements of the Quality System Regulation...

Source: mondaq.com