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In Brief: FDA CADx public workshop

This article was originally published in The Gray Sheet

Executive Summary

FDA CADx public workshop: Premarket requirements for computer-aided diagnostic (CADx) medical devices are on the agenda of an FDA public workshop Jan. 26, from 9 a.m. to 4:30 p.m. at the agency's Parklawn Building, 5600 Fishers Lane, Rockville, Maryland. FDA is holding the workshop to gain input on reviewer guidance for device description and assessment methodologies in premarket submissions, which the agency is developing in anticipation of increasing numbers of submissions for CADx devices. Advanced registration is required: contact Mary Anderson, FDA's Office of Science and Technology, at 301/443-5020 ext. 40...
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