FDA seeks to speed up 510(k) process

The FDA has issued guidance regarding the Medical Device User Fee Amendment of 2012 and the agency’s intention to use additional revenues from fees to reduce turnaround time for 510(k) submissions.

“The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical review process,” the Oct. 15 document read.

From fiscal years 2008 to 2012, the FDA reviewed 90 percent of submissions within 90 days and 98 percent of submissions within 150 days. If performance goals outlined in the guidance document are met, the FDA would review all submissions within 60 days 65 percent in fiscal year 2013, 75 percent of the time in fiscal year 2014, 85 percent of the time in fiscal year 2015 and 95 percent of the time in fiscal year 2016 and beyond. The FDA also set a goal for average total time to decision for 510(k) submissions at 124 days.

The guidance is available in its entirety on the FDA website.