Study Shows ‘Substantial’ Increase in FDA 510(k) Review Times

The second major study released in as many months is showing that total calendar days for CDRH reviews have increased substantially. In 2006, applications for 510(k) devices cleared by the FDA took an average of 96 days. That number rose to 132 days in 2010, data released Wednesday by consulting firm Emergo Group shows.
Devices & Diagnostics Letter