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Home » Adding Antimicrobials to Medical Devices Requires New 510(k)s, U.S. FDA Says
Adding Antimicrobials to Medical Devices Requires New 510(k)s, U.S. FDA Says
September 10, 2007
Adding an antimicrobial agent to a marketed medical device generally represents a “significant modification” that requires a new 510(k) submission, the U.S. Food and Drug Administration (FDA) said in a recent draft guidance.
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