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Oct. 28 -- The Food and Drug Administration's Center for Devices and Radiological Health said it was unable to process 100 device company submissions that it received during the 16-day government shutdown, which will push back the agency deadlines for meeting its review goals.
In an Oct. 24 e-mail to industry representatives, the CDRH said any fee-paying submission submitted between Oct. 1 and Oct. 16 will be assigned a receipt date of Oct. 17, the date the government reopened. These submissions include 510(k) premarket notifications and premarket approval applications.
The agency said it also expects to receive “more submissions than usual this week and next--due to companies that may have withheld their submissions during the shutdown or may have been waiting on small business designations.”
During the shutdown, the FDA wasn't able to accept user fee-associated drug and device applications at the start of fiscal year 2014. Erica V. Jefferson, deputy director of the FDA's Office of Media Affairs, said Oct. 17 in a statement that the agency is prioritizing its work as it transitions back to normal operations after the shutdown. As of Oct. 18, the CDRH said it logged in all of the 100 submissions accordingly.
During the shutdown, the agency relied on some carryover user fees from FY 2013 for its limited review activities . About half the agency's staff was on furlough.
“Although we don't know what those numbers will be, we are prepared to log in as many submissions as possible each day. If we are unable to log in a submission on the same day it was received, we will log it in the following business day. We plan to continue this process until we return to normal submission levels,” the FDA's devices office said.
The agency also said it will continue to work toward meeting its review goals despite the delay, “provided that all applicable fees have been paid as required.”
Industry representatives did not seem concerned about the agency's user fee commitments. Janet Trunzo, senior executive vice president, technology and regulatory affairs at the Advanced Medical Technology Association, said “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.”
The agency said it was able to log in and review all other non-user fee submissions, such as investigational device exemptions, “per our standard procedures.”
Lakshman Ramamurthy, director of FDA strategy and regulatory policy at Avalere Health, told Bloomberg BNA Oct. 25 that the agency most likely will review the backlog on a first-come, first-served basis, but the agency's clocks “are scrambled.”
The manufacturer submissions were received, but since they were not logged by the agency, the review clock wasn't starting, Ramamurthy said. Manufacturers also will have to deal with meetings with device reviewers that were cancelled during the shutdown, Ramamurthy said, which could delay the devices even more.
In an Oct. 25 analysis, the Alliance for a Stronger FDA said catching up on a 12 working-day delay “will be difficult, especially while new work is coming in at an even faster clip because of the delays.” The alliance includes industry trade groups.
However, Ramamurthy said he did not want to “overstate the impact” of the shutdown. The impact will mainly be felt on a case-by-case basis with individual companies and devices. “It's unclear if two weeks will make a huge dent” in overall agency operations, he said, but it could have been much worse if the shutdown had persisted.
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