On December 22nd, 2018, the Federal Government went into a partial shutdown. Forty one percent of the FDA staff has been furloughed, which means that out of 17,397 FDA staff members, only 10,344 members have been retained for work. The number of furloughed employees may increase as the shutdown progresses...

1. What the Government Shutdown Means to
the Med Device Industry?
By: Nikita Angane, MS
On December 22nd, 2018, the Federal Government went into a partial shutdown. Forty one
percent of the FDA staff has been furloughed, which means that out of 17,397 FDA staff
members, only 10,344 members have been retained for work. The number of furloughed
employees may increase as the shutdown progresses. While these numbers are very horrifying
and make us question the state of public health in the country, the actual impact is even more
hard-hitting.
What remains unaffected by the shutdown:
FDA will continue to respond to emergencies such as high-risk medical device recalls, screening
of imported medical devices entering the US, continue surveillance for adverse events and
conduct criminal investigations when public health is greatly at risk.
The FDA will also carry over the user fee balances from 2018 and continue to review the pre-
market applications whose user fees have been received prior to December 22nd, 2018; however,
the review clock for these applications has been greatly impacted.
FDA activities affected by the shutdown:
All routine medical device facility inspections have been halted along with all the research
activities. FDA cannot accept any new pre-market applications that require a user fee, which
means all those companies who planned on submitting a 510(k), PMA or any other premarket
application in 2019 will have to wait until the shutdown has ended.2
The shutdown has not only affected the public health that FDA is committed to protecting but
has also impacted the personal lives of the federal employees. Weston Szymanski, a consumer
safety officer in the FDA's Stoneham, Massachusetts office said: "The real victims are the
American consumer and federal government employees." Some FDA employees have also
taken to work without the assurance of a paycheck. FDA Commissioner, Dr. Scott Gottlieb,
stated that, "Wherever we can, we will look at the safety mission first and foremost, but you
know what will happen is that more of the routine work and more of the day-to-day review work
will slow down, a lot of it slowed down already." 3
We are closely monitoring the situation in D.C. and will keep you updated on how it will further
impact the medical device industry.

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If you have any questions or concerns, please call us at (248) 987- 4497 or email at
info@emmainternational.com.