Opportunity
Federal Register #2026-22883
FDA final guidance for validating diagnostic tests for emerging pathogens
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
November 10, 2026
Identifier
2026-22883
The U.S. Food and Drug Administration (FDA), within the Department of Health and Human Services, issued final guidance on validating in vitro diagnostic devices for emerging pathogens during a declared public health emergency. - Government buyer: U.S. Department of Health and Human Services, Food and Drug Administration (FDA); no sub-agency or office is specified. - Notice type: Guidance announcement, not a procurement opportunity or award. - Guidance scope: General recommendations on validation data and information for tests submitted before an Emergency Use Authorization (EUA), submitted with an EUA request, or offered under an applicable enforcement discretion policy. - Additional material: An associated template is included. - OEMs and vendors: None identified. - Products, services, quantities, and part numbers: None requested.
Description
The FDA announces the availability of a final guidance on validating in vitro diagnostic devices for emerging pathogens during an applicable public health emergency declaration. The guidance provides general recommendations for validation and addresses test data and information submitted in a pre-Emergency Use Authorization, an EUA request, or for tests offered under an applicable enforcement discretion policy. It also includes an associated template and discusses flexible, consolidated recommendations informed by comments on the draft guidance. This is a notice of guidance availability, not a procurement opportunity.