Addressing The Backlog: Government Shutdown Ends, Now FDA Has To Catch Up-thegraysheet: 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 "$18.4 Million In User Fees Left In CDRH’s Coffers, How Long Will It Last?" — "The Gray Sheet," Oct. 11, 2013.) Reviewers also did some work on new submissions, such as investigational device exemptions, that are not tied to a user fee. But FDA was prevented from accepting any new FY 2014 user-fee funded device submissions, including PMAs and 510(k)s, during the shutdown.
