The group’s data revealed that the rate of 510(k) submissions cleared within three months improved to 42 percent in 2011 from 40 percent in 2010. Average review times also fell to 138 days in 2011 from 146 days in 2010.
Most Class II, as well as some Class I and III medical devices, must receive FDA 510(k) premarket notification prior to being sold commercially in the U.S. Half of the devices submitted for clearance in 2011 were orthopedic, cardiovascular, general and plastic surgery or radiology-related.
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