Photo by Jose Fontano via Unsplash
October 2, 2025 – By Danielle Kirsh
The FDA said it will not accept new medical device submissions that require payment of user fees during the Trump administration’s latest government shutdown.
U.S. federal government agencies shut down on Wednesday, as lawmakers in Congress failed to reach a bipartisan deal to extend government funding ahead of the Oct. 1 deadline.
According to the agency’s contingency plan, reviews of existing submissions and requests to conduct important clinical research can continue using carryover user fee funding. FDA also said it will maintain work related to imminent threats to human life, including recalls, adverse event surveillance, import reviews, for-cause inspections and enforcement actions.
Medical device user fees support the review and approval of new medical products, reviews of important clinical research requests, the issuance of guidance and other necessary activities that still allow patients to access new therapies, according to the FDA.
However, most device programs without carryover funding are paused. That includes pre-approval inspections and policy development not directly tied to urgent safety issues. Regulatory science research and longer-term innovation efforts are also curtailed until appropriations are restored.
