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510(K) TOTAL REVIEW TIME AVERAGES 195 DAYS IN FISCAL 1993

This article was originally published in The Gray Sheet

Executive Summary

510(K) TOTAL REVIEW TIME AVERAGES 195 DAYS IN FISCAL 1993 (year ended Sept. 30), up 55% from 126 days in fiscal year 1992. Total review time represents the number of days an application spends under review at FDA's Office of Device Evaluation, including time spent "on hold" pending sponsor submission of additional data.

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