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510(k) Appeals Record Bodes Well For Future Of Dispute Resolution - FDA

This article was originally published in The Gray Sheet

Executive Summary

Over 40% of 510(k)-related appeals filed with FDA since January 1993 have been found in favor of the appellant, James Norman, a staffer in the agency's Center for Devices and Radiological Health, reported during the recent Health Industry Manufacturers Association's "Device Submissions Workshop."

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