Expect FDA 510(k) Review Times To Increase

The average decision time for FDA 510(k) clearance was 113 days in 2008. This is up 30% from 2005. FDA time-frame is supposed to be 90 days.

The increased review time is likely to continue. This a new FDA and there have been concerns raised regarding the 510(k) process. We’ll know more in the coming months. Read more about this from MassDevice Exclusive: FDA Lags on 501(k) Approvals.