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FDA ELECTROSURGICAL DEVICE GUIDANCE INCLUDES REVISIONS OF INTENDED USE, EtO, WARNINGS PROVISIONS; CLINICAL SECTION NEEDS CLARIFICATION, INDUSTRY REP SAYS

This article was originally published in The Gray Sheet

Executive Summary

FDA needs to provide additional guidance on when clinical data should be included in 510(k)s for electrosurgical devices, Robert O'Holla, the industry representative to the agency's General and Plastic Surgery Devices Panel, said at a Sept. 21 meeting of the advisory committee in Gaithersburg, Maryland.
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