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FDA 510(k) backlog

This article was originally published in The Gray Sheet

Executive Summary

Number of overdue 510(k)s (those under FDA review for more than 90 days) drops to 602 at the end of August, down from 768 in July. The overall backlog of pending 510(k)s also slid, from 4,443 in July to 4,375 last month, while average FDA review time decreased from 166 to 147 days for the period



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