Regulatory Focus™ > News Articles > Study: 510(k) Clearance Down 12% Since 2006, Time for Approval Up 40%

Study: 510(k) Clearance Down 12% Since 2006, Time for Approval Up 40%

Posted 17 January 2012 | By Alexander Gaffney, RAC 

A study released this week by the consulting firm Emergo Group shows that the number of 510(k) submissions that are ultimately cleared by the US Food and Drug Administration has decreased since 2006.

510(k) submissions are used by FDA to clear products that are "substantially equivalent" to low-risk predicate devices that have been shown to be safe and effective.

The Emergo analysis shows that 510(k)s were cleared at a rate of 85.8% in 2006, and decreased steadily every year thereafter. FDA cleared 82.5% of 510(k)s in 2007, 79.6% in 2008, 75.7% in 2009, and 73.6% in 2010. The 2010 number could increase as some devices remain in the approval process.

The average time it takes for devices to be cleared by FDA increased as well. In 2006, it took an average of just 96 days for a device to be cleared. In 2010, devices required an average of 135 days to achieve market clearance-an increase of 40%.

Medical device classes exhibited wide ranges of "submission to clearance" rates of speed. Radiology devices took just 72 days, on average, to be cleared by the agency, while immunology devices took more than double that time with an average of 182 days.

Devices cleared most often by the agency-cardiovascular (11.9% of total), orthopedic (15.4% of total), radiology (10.4% of total) and general and plastic surgery (11.8% of total) devices-were among the devices with the lowest average "submission to clearance" times, coming in at 103 days, 111 days, 72 days and 114 days, respectively.

The study includes 15,168 medical devices submitted to the agency between 1 January 2006 and 6 January 2012.


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