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

Article preview from "The Gray Sheet" - October 21, 2013

 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.

 

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

Article preview from "The Gray Sheet" - October 21, 2013

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. 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. 

Now that the government has been up and running since Oct. 17, CDRH has to figure out how to address a bigger-than-usual influx of submissions that were waiting in the wings.

“We are working on a plan for how best to handle the growing backlog of FY 2014 submissions that are subject to a user fee and will communicate that plan to industry,” Peper Long, CDRH’s associate director for external relations, told “The Gray Sheet.”

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