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

After the two-week shutdown, FDA staff are facing a backlog of fiscal year 2014 device submissions. The agency says it is working on a plan and assessing its ability to meet its MDUFA III commitments. The bigger concern, however, may be the regulatory uncertainty created by the short-term deal in Congress.

Furloughed FDA 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 million in carryover user fees from fiscal year 2013. (See Also see "$18.4 Million In User Fees Left In CDRH’s Coffers, How Long Will It Last?" - Medtech Insight, 11 October, 2013..) Reviewers also did some work on new submissions, such as investigational device exemptions, that are not tied to a user fee

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