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.
President Donald Trump and Vice President JD Vance have indicated in press conferences about the shutdown that layoffs will happen if the shutdown continues for weeks. Office of Management and Budget Director Russ Vought said on a call that reduction-in-force and layoffs would happen in the next two days, CBS News reported. However, FDA Commissioner Marty Makary reportedly told employees that FDA would not have any mass firings as part of the government shutdown, according to Bloomberg Law.
In its contingency plan, FDA said 13,872 employees – about 86% of its workforce – will keep working during the shutdown. That includes 10,740 exempt staff funded by carryover user fees and 3,132 excepted staff whose roles are necessary to protect human life or government property.
The pause is expected to affect device makers preparing to file new 510(k), de novo or PMA submissions. Manufacturers with ongoing submissions may see less disruption in the short term, as those reviews can continue under existing fee funding.
FDA said in a LinkedIn post, “All FDA activities related to imminent threats to the safety of human life or protection of property will continue. This includes detecting and responding to public health emergencies and continuing to address existing critical public health challenges by managing recalls, mitigating drug shortages, and responding to outbreaks related to foodborne illness and infectious diseases. It also includes surveillance of adverse event reports for issues that could cause human harm, the review of import entries to determine potential risks to human health, conducting for cause and certain surveillance inspections of regulated facilities, and related regulatory testing activities, and criminal enforcement work and certain civil investigations.”
How the FDA operates in a government shutdown
Medical device companies pay fees to FDA when they register their businesses and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S., and for certain other types of submissions. These actions fall under the Medical Device User Fee Amendments. Medical Design & Outsourcing