Aktuelle Entwicklung: Shutdown beendet, FDA bald wieder voll Handlungsfähig
The dispute over the US budget between Donald Trump's administration and the Democratic opposition led to another shutdown of the US government on 1 October 2025.
This means that almost all US government agencies are currently experiencing massive cuts, employees are no longer being paid and authorities are having to suspend their work.
The US Food and Drug Administration FDA is also affected by the cuts.
The FDA is responsible, among other things, for processing applications for approval of medical devices.
However, due to the shutdown, the FDA is currently unable to process any applications for approval. For the duration of the shutdown, the agency is limiting its work to protecting public health, meaning it is only processing cases involving serious incidents in the US healthcare market.
For Manufacturers of Medical Devices, as Well as for BEO BERLIN, this Means a Forced Pause in US Business.
According to its own statement, the FDA ‘cannot accept user fees paid for applications submitted in fiscal year 2026.’ It follows that the FDA is currently unable to process any fee-based applications.
BEO BERLIN will, of course, continue to produce technical documentation, prepare applications and assist its clients with regulatory challenges. However, our cooperation with the US authorities has been put on hold until further notice.
It is Currently Unclear When the US Government Will End the Shutdown and the FDA Will be Able to Resume its Regulatory Work.
We will keep you informed about the status of opportunities to place medical devices on the US market!
Contact us if you have any questions!
(1 Rating(s), average: 5.00 out of 5)
Loading...
