By Nathaniel Weixel
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.
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.
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.”
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
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.
To contact the
reporter on this story: Nathaniel Weixel in Washington at email@example.com
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