Analysis of US FDA Data Shows 37% Increase in 510(k) Clearance Times Since 2006

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An examination of publicly available FDA data by Emergo Group on 510(k) clearances over the last five years indicates that 80% of devices receive clearance within six months.

Emergo Group, an Austin-based consulting firm that assists medical device manufacturers with regulatory compliance, has completed a comprehensive analysis of medical device 510(k) submissions cleared by the US Food and Drug Administration (FDA). Most Class 2 devices, and some Class 1 and Class 3 products as well, must go through the 510(k) review process, also known as a Premarket Notification.

The analysis examined 13,621 Premarket Notification submissions cleared by the FDA for the period January 1, 2006 to May 23, 2010. The full analysis can be downloaded at

Key findings include:

  •     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, notes, “In looking at this analysis, I would caution people about automatically assuming that the FDA is taking more time to review 510(k) submissions. What this analysis shows is that the average length of time from when a 510(k) premarket notification application is submitted by a manufacturer to when it is cleared by FDA has increased pretty substantially since 2006.

"One possible explanation may be that FDA reviewers are requesting more clinical performance data from a higher percentage of manufacturers submitting 510(k) applications," Schorre adds. "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.”

The aggregate data from 2006 to 2010 shows that product submissions in the radiology, cardiovascular, orthopedic and general/plastic surgery categories took an average of 72, 90, 93 and 96 days to clear respectively -- substantially less time than the average over the study period. Devices in these four product categories alone account for more than half of all 510(k) submissions to the FDA.

The analysis also revealed that the overall number of 510(k) applications cleared by the FDA dropped by about 10% between 2006 and 2007, but has remained relatively stable since 2008 at between 3,000 and 3,100 cleared devices per year.

This is the first year Emergo Group has completed an analysis of FDA 510(k) data. The firm plans to update the analysis every year going forward.

About Emergo Group:

Emergo Group, Inc. specializes in global medical device regulatory compliance, quality assurance, clinical trial management, reimbursement and medical distribution consulting. ¬The company has more than 1,500 medical device and IVD clients in 50 countries worldwide. Emergo Group is headquartered in Austin, Texas and maintains offices in 13 countries throughout the Americas, Europe, Asia and Australia.

For more information, contact:
Chris Schorre, VP of Global Marketing
Telephone: +1 512 600 7606    

Stewart Eisenhart, Regulatory Editor
Telephone: +1 512 600 7627


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