Update: FDA resumed operations on Saturday, January 26, 2019.
Disagreements on security issues between Donald Trump and Congress, triggered by the President’s request for funding for the US-Mexico border wall, have caused a US Government partial shutdown starting December 22, 2018, still ongoing.
Due to this partial shutdown, the FDA is unable to collect user fees for the 2019 fiscal year. As a result, it cannot accept or evaluate new premarket requests related to Medical Devices subject to payment of such user fees.
With approximately 41% of the staff placed on furlough due to a lapse in funding, the FDA is forced to operate at reduced capacity. Waiting for further developments, the 23rd FDA Commissioner Scott Gottlieb has reassured the medical device manufacturers that the FDA will continue, though at a slower pace, to evaluate the ongoing 510 (k) premarket requests whose user fees have been paid before December 22nd, 2018.
However, if the user fees have not been paid in full or if the payment has not been fully processed before December 22nd 2018, the premarket requests will remain “on hold” until the reopening of the Government, when the payment can be completed.
Thanks to user fees paid by pharmaceutical and Medical Devices companies, at the moment the FDA is able to pay the “essential” staff that will continue to carry out “critical” activities, such as recall of Medical Devices, screening of imported Medical Devices and essential market surveillance activities to ensure that the public health will be safeguarded.