FDA is shortening time to review and clear 510(k)’s

FDA 510(k) Review Times See Improvements  (Today's Medical Developments)
Review times for medical device 510(k) premarket notifications by the U.S. Food and Drug Administration (FDA) improved somewhat in 2011 after several years of lengthening review times, according to a new analysis of publically available FDA data by Emergo Group.
Most Class II devices and some Class I and III medical devices submitted for registration in the U.S. are reviewed via the FDA’s 510(k) Premarket Notification program before commercialization can begin.
Emergo Group’s analysis covered 18,615 records pulled from th...