How long it takes for a 510(k) submission to be cleared by the US FDA

Emergo Group performed an analysis of publicly available FDA 510(k) data pulled from the FDA website on 15 January 2013. Data was pulled for the time period 1 January 2006 through 31 December 2011. Total number of records analyzed was 18,615. All data was sorted by the date FDA received a 510(k) submission, not the date it was cleared. Thus, 2010 data, for example, shows the statistics for all 510(k) submissions received by the FDA between 1 January 2010 and 31 December 2010. We only analyzed data for 510(k) submissions through the end of 2011 to allow a full 12 months for FDA 510(k) submissions to be cleared. Our analysis has shown that 95-97% of all 510(k) applications cleared by the FDA occur within one year of initial submission date.

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