Analysis finds slight improvement in FDA's 510(k) process since 2011

02/19/2014 | MassDevice.com (Boston)

The FDA took an average of 166 days to review medical devices submitted under the agency's 510(k) clearance process last year, down from 176 days in 2011, according to an analysis by Emergo Group. The current review times, however, were higher by about 50% compared with 2006, which had average review times of 110 days, the analysis notes.

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