Addressing The Device Backlog: Government Shutdown Ends, Now FDA Has To Catch Up

Furloughed FDA Center for Device and Radiologic Health staff have returned to work after the two-week government shutdown to face a backlog of submissions. Some in industry are anxious to hear how the agency plans to deal with the situation, particularly how the backlog will impact its ability to meet user fee performance goals.

During the 16-day-long government shutdown, the agency continued to review device submissions made by companies prior to Oct. 1, with about half of its employees at work funded by $18.4...