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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Office of Device Evaluation annual report: The device review office's fiscal 2009 annual report, released Sept. 2, paints a more favorable picture of device review and approval times than prior-year reports. For pre-market approval applications, total FDA review time decreased from 2006 to 2008, from 344 FDA days to 225 FDA days, according to the report. Complete numbers are not in for 2009. FDA's average time for 510(k) review, which had trended upward in recent years, is leveling off, the report noted. Average 510(k) review time went from 54 FDA days in 2005 to a peak of 67 days in 2007, decreasing to 65 days in 2008 and 63 days in 2009 (but the recent cohorts are not yet complete). FDA approved three de novo applications, for lower-risk devices that cannot be cleared via traditional 510(k), in fiscal 2009

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