New Study Shows Medical Device Review Taking 37% Longer

The Emergo Group released a report this week showing that FDA is taking longer to review new submissions for medical technologies. 

Emergo reviewed the number of submissions the FDA clears each year and how long it takes to win 510(k) clearance to obtain an average "submission to clearance" time. 

In 2006, 510(k) applications took an average of 96 days to be cleared by the FDA, while in 2010 the time increased to 132 days. 

More than 53 percent of 510(k) submissions from January 1, 2006, to May 23, 2010, were cleared within three months, and more than 80 percent made it through within six months, according to the report. 

To read more about this study, click here.