How long does it takes for a FDA 510(k) submission to be reviewed?

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. Data posted on January 31, 2013. Updated every year.

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Total 510(k) submissions cleared by FDA per year

	Number Cleared: 2006 – 3,325 2007 – 3,068 2008 – 3,134 2009 – 3,104 2010 – 2,929 2011 – 3,055 *
Comments: After a sharp drop in submissions in 2010,the number FDA 510(k) submissions cleared by the FDA rebounded somewhat in 2011. * Final numbers for 2011 may rise by 3-5% as submissions received by FDA in late 2011 are cleared by FDA in early 2013. Based on historical analysis, 95%-97% of cleared submissions happen within 12 months of submission to the FDA.

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Average time for 510(k) submissions to clear

	Average number of days to clearance: 2006 – 97 days 2007 – 110 days 2008 –118 days 2009 – 136 days 2010 – 146 days 2011 – 138 days
Comments: After several years of ever lengthening review times, the trend reversed in 2011. The number of 510(k) submissions submitted in 2011 which cleared within 3 months increased to 42% from 40% and the average number of days decreased to 138 days.

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Clearance time by device type

Comments:
On average, radiology products clear the 510(k) process more quickly than other categories of devices. Half of all products submitted for FDA 510(k) clearance fall into these four categories:

• Orthopedic
• Cardiovascular
• General/Plastic Surgery
• Radiology

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25 most common devices subject to the FDA 510(k) process

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FDA 510(k) submission by type: 2006-2011