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In Brief: FDA third-party pilot

This article was originally published in The Gray Sheet

Executive Summary

FDA third-party pilot: Thirty-seven organizations apply for FDA certification to conduct third-party 510(k) reviews as part of the agency's two-year pilot program. Among groups applying are testing/certification labs, European notified bodies, an institutional review board, a state government and a "handful" of consulting firms. The agency expects to select 10 groups to conduct the external reviews; third-party training is set for July 22-23, with the program set to begin Aug. 1...



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