Print“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.”
A new study finds that, on average, there’s been a 37 percent increase since 2006 in the time it takes medical devices to win premarket clearance from the U.S. Food and Drug Administration.
The study adds to growing chorus from industry over the time it takes to win regulatory approval of medical devices as the FDA readies for Institute of Medicine recommendations on how to overhaul the review process and Congress turns its attention to renewal of the Medical Device User Fee Act, which is set to expire in 2012.
Emergo Group, an Austin-based consulting firm that assists medical device manufacturers with regulatory compliance, analyzed medical device 510(k) submissions cleared by the FDA between January 1, 2006 and May 23, 2010. The 510(k) review process, also known as premarket notification, is the process most Class II devices, and some Class I and Class III products, must go through before they can marketed.
The analysis examined 13,621 submissions.
While the study found that more than half of the applications cleared in less than three months and that more than 80 percent cleared within six months, on average the agency took 37 percent longer to clear a device in 2010 than in 2006—132 days last year compared to 96 days in 2006.
It’s not clear from the study what’s behind the increased review time. “In looking at this analysis, I would caution people about automatically assuming that the FDA is taking more time to review 510(k) submissions,” says Chris Schorre, vice president of Global Marketing for Emergo Group. “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.”
Schorre suggests that one 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,” he says.
June 23, 2011
http://www.burrillreport.com/article-analysis_of_fda_data_shows_average_review_time_up.html
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