Analysis finds improvement in FDA's 510(k) review process

02/25/2013 | BeckersOrthopedicAndSpine.com

The number of medical devices cleared within a period of three months under the FDA's 510(k) program improved from 40% in 2010 to 42% in 2011, according to an Emergo Group analysis. The report also shows the average time it takes for the FDA to review 510(k) applications dropped from 146 days in 2010 to 138 days in 2011.

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