Analysis of US FDA Data Shows 37% Increase in 510(k) Clearance Times Since 2006
Emergo Group, an Austin-based consulting firm that assists medical device manufacturers with regulatory compliance, has completed a comprehensive analysis of medical device 510(k) submissions cleared by the US Food and Drug Administration (FDA). Most Class 2 devices, and some Class 1 and Class 3 products as well, must go through the 510(k) review process, also known as a Premarket Notification.
The analysis examined 13,621 Premarket Notification submissions cleared by the FDA for the period January 1, 2006 to May 23, 2010. The full analysis can be downloaded at www.emergogroup.com/research
Key ...

