MASSDEVICE ON CALL — About 100 submissions to the FDA’s Center for Devices & Radiological Health languished during the 16-day shutdown of the federal government earlier this month, meaning it won’t meet its review goals, the agency told stakeholders.
Any submissions for 510(k) clearance or pre-market approval received between Oct. 1, when the shutdown began, and its end on Oct. 16 will be marked as received Oct. 17, Bloomberg BNA reported.
And the CDRH expects to receive a backlog of applications that companies may have held up while the shutdown was under way, according to the news service.
"FDA has communicated its status and plans for addressing any backlog caused by the recent government shutdown. The agency has given no indication that it will be unable to meet its performance goals under the new user fee agreement," Janet Trunzo, senior executive vice president for technology and regulatory affairs at AdvaMed, told Bloomberg BNA.
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