FDAnews
www.fdanews.com/articles/134635-fda-on-track-to-meet-510-k-review-times-for-fiscal-2010

FDA on Track to Meet 510(k) Review Times for Fiscal 2010

February 28, 2011
The FDA appears on track to meet its 510(k) review times for fiscal 2010, but the jury is still out on where it stands on PMAs, the agency says in its annual Medical Device User Fee and Modernization Act report to Congress. The number of 510(k) submissions decreased in fiscal 2010 but still reached the second highest level in the past five years at 3,936, down from 4,153 in fiscal 2009. The agency clarified that it measures review times in “FDA days,” not calendar days. This means the clock is not running when the agency asks additional questions of sponsors, who sometimes take months to respond.
Devices & Diagnostics Letter