Impacts of the 2026 Government Shutdown on FDA Operations

On October 1, 2026, the U.S. federal government, including the Food and Drug Administration (FDA), began an orderly shutdown due to Congress's failure to pass appropriations bills or a continuing resolution. This shutdown has significant implications for the FDA's operations, particularly regarding the approval of new medical products and devices.

FDA Announces Ramifications of Government Shutdown Due to 2026 Lapse in Funding

During the shutdown, the FDA has stated it will continue essential functions that address imminent threats to public health, such as monitoring foodborne illness outbreaks, supporting high-risk food and medical product recalls, and conducting civil and criminal investigations when public health is at risk. However, the agency is unable to accept new drug applications, generic drug applications, biological product applications, biosimilar applications, animal drug applications, or medical device submissions that require user fee payments. This is due to the FDA's lack of legal authority to collect these fees during the lapse in funding.

FDA Announces Ramifications of Government Shutdown Due to 2026 Lapse in FundingFDA suspends receipt of new drug and medical device applicationsFDA halts new device submissions during government shutdownNBC NewsNewsweek

The inability to accept new applications is expected to delay the availability of critical medical products. The FDA's Human Drugs Program has halted most activities related to unapproved prescription drugs. The agency's Commissioner’s National Priority Voucher (CNPV) program, aimed at expediting the review of certain drug applications, is also at risk due to these funding constraints.

FDA Announces Ramifications of Government Shutdown Due to 2026 Lapse in Funding

Despite the shutdown, approximately 86% of FDA staff, or 13,872 employees, will continue working. This includes 10,740 employees funded by carryover user fees and 3,132 whose roles are deemed necessary for public safety. Existing submissions and requests for clinical research can continue under existing fee funding, but new submissions will face significant delays.

FDA halts new device submissions during government shutdown

The shutdown has drawn criticism from various stakeholders. Former Senator Richard Burr has warned that the shutdown could last for an extended period, exacerbating delays in FDA processing times. Additionally, anti-abortion groups have expressed outrage over the FDA's recent approval of a second generic version of mifepristone, a medication used in abortions, arguing that the agency has not conducted adequate safety reviews.

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There are discrepancies regarding the potential duration of the shutdown and its impacts. While some analysts predict a prolonged shutdown, others suggest that the FDA may find ways to mitigate the effects on ongoing submissions. The exact timeline for the resumption of full operations remains uncertain.

FDA halts new device submissions during government shutdown

As the government shutdown continues, the FDA's ability to process new applications and maintain its regulatory functions will be closely monitored. The agency's future actions will depend on Congressional decisions regarding funding and appropriations, which will ultimately determine the timeline for restoring full operational capacity.

FDA halts new device submissions during government shutdown