Photo by Jose Fontano via UnsplashOctober 2, 2025 – By Danielle KirshThe FDA said it will not accept new medical device submissions that require payment of user fees during the Trump administration’s latest government shutdown. 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.