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.1
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.2 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.
1Vox (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
2Health 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/
