Nearly 14,000 devices were cleared via 510(k) in the period January 1, 2006 to May 23, 2010. The Emergo Group has released comprehensive analysis of medical device 510(k) submissions cleared by FDA. The report “An analysis of FDA 510(k) releasable data from 2005-2010” is available in PDF form.

Among the group’s findings are the following:

• More than 53% of FDA 510(k) submissions are cleared by the agency in less than 3 months. More than 80% are cleared within 6 months.
• In 2006, 510(k) applications cleared by the FDA took an average of 96 days. For submissions made in 2010, the average time from submission to clearance is projected at 132 days, a 37% increase.

Chris Schorre, VP of Global Marketing for Emergo Group cautions that in looking at the data, they should not assume that FDA is taking more time to review 510(k) submissions. He says the analysis shows only that the average length of time from when a 510(k) application has been submitted to when it was cleared by FDA has increased substantially.

“One possible explanation may be that FDA reviewers are requesting more clinical performance data from a higher percentage of manufacturers submitting 510(k) applications,” says Schorre. “This would, in turn, lead to an overall increase in 510(k) clearance times because manufacturers need to respond to those additional requests from the FDA."

Methodology Notes: Emergo Group performed an analysis of FDA 510(k) data downloaded from the FDA website on May 23, 2011. Data was pulled for the time period January 1, 2006 to May 23, 2010. Total number of records analyzed was 13,621. All data was sorted by the date FDA received a 510(k) submission, not the date it was cleared. Thus, 2008 data, for example, shows the statistics for all 510(k) submissions received by FDA between January 1, 2008 and December 31, 2008.