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Antimicrobial guidance update

This article was originally published in The Gray Sheet

Executive Summary

Final guidance in FDA's pipeline on 510(k) submissions for devices or combination products that incorporate antimicrobial agents faces delays from a change in reviewers at the Office of Chief Council followed by the change in administration, the agency says (1"The Gray Sheet" Sept. 1, 2008, p. 6). Once finalized, FDA will begin new guidance on performance testing for the devices. "The majority of antimicrobials that we see on medical devices do elute off the device to a greater or lesser extent," said Sheila Murphey, infection control branch chief at FDA's device center. "We need to know how much; we need to know how much over a period of time; we need to know how much over a long period of time." Performance testing should be quantitative and support indications and conditions for use. It may include in vitro, in vivo and clinical testing, Murphey said

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