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510(k) average total review time drops to 157 days in first four months of FY 1996.

This article was originally published in The Gray Sheet

Executive Summary

510(K) AVERAGE TOTAL REVIEW TIME OF 162 DAYS FOR JANUARY represents a slight increase from the 157-day average for December, according to FDA's most recent figures. The total average review time, which covers the period of the agency's receipt of a premarket notification to a final decision, has fluctuated over the first four months of FY 1996 (began Oct. 1) but has remained below the average review time of 178 days in fiscal 1995 ("The Gray Sheet" Oct. 9, 1995, p. 3). Total 510(k) review time hit a low of 137 days in October and jumped to 170 days in November, averaging about 157 days for the first four months of the fiscal year overall.

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