Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff

Issue Date: January 6, 2025
Issued by: Center for Devices and Radiological Health,Office of Product Evaluation and Quality,Office of In Vitro Diagnostics and Radiological Health
Topic(s): IVDs (In Vitro Diagnostic Devices)
Status: Draft

Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases and public health emergencies. This draft guidance describes general recommendations for the validation of in vitro diagnostic devices (IVDs) for emerging pathogens during an applicable declaration under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These recommendations apply to test data and information submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or to a test offered under an applicable enforcement discretion policy. A generic template is also being made available through download from FDA’s website, which reflects FDA’s current thinking on validation study recommendations.

Download the Guidance Document