The government has temporarily “re-opened” until Feb 15th after the longest government shutdown in US history that lasted for 35 days. Here’s what’s going to happen...

1. The End of the Longest Government
Shutdown
By: Nikita Angane, MS
The government has temporarily “re-opened” until Feb 15th after the longest government
shutdown in US history that lasted for 35 days.
Here’s what’s going to happen:
Some FDA officials carried out inspections and other critical activities without being paid to
continue to respond to threats to public health. Around 800,000 federal workers have been
promised a back pay.i
The resumed activities amid the shutdown were funded by the carryover user fees of certain
review applications. These applications were experiencing delays in their review and now pose
as a backlog since the industry will now start submitting new applications after a long wait.
FDA has started accepting new pre-market review applications but of course, the timelines of the
review will suffer because of the backlog.
The shutdown has already caused lasting damage in other agencies as well. As for the FDA, the
agency will still face a backlog of applications and other regulatory activities that will continue
for the near future.ii Medical device manufacturers who plan on submitting a 510(k) or a PMA
anytime soon will face delayed clearances for their devices.
We are closely monitoring the activities in D.C. and will keep you updated on any changes that
will impact the Medical Device industry.
If you need help in preparing your 510(k) or PMA, please call us at 248-987-4497 or email us at
info@emmainternational.com.
i Vox (Jan 2019) The government is reopened (for now). But the recovery process may take a while. Retrieved on
02/07/2019 from https://www.vox.com/2019/1/26/18198630/government-shutdown-recovery
ii Health Law Advisor (Jan 2019) Not Business as Usual: The Government Shutdown’s Impact at FDA. Retrieved on
02/07/2019 from https://www.healthlawadvisor.com/2019/01/22/not-business-as-usual-the-government-shutdowns-
impact-at-fda/