Emergo Group recently completed a comprehensive analysis of medical device 510(k) submissions cleared by the US Food and Drug Administration (FDA). 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. Emergo’s analysis examined 13,621 Premarket Notification submissions cleared by the FDA for the period January 1, 2006 to May 23, 2010. you can download the full analysis in PDF format at www.emergogroup.com/research.
Here are some key findings of the report:
- 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. 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 3000 and 3100 cleared devices per year.
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