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Product safetyFDAUnited StatesImports

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

10 November 2026

In plain English

FDA issued final guidance on validating in vitro diagnostic devices for emerging pathogens during a Section 564 declared public health emergency, covering pre-EUA, EUA requests, and enforcement discretion tests.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
10 November 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency." The guidance describes general recommendations for the validation of in vitro diagnostic devices (IVDs) for emerging pathogens during an applicable declaration of public health emergency (PHE). This guidance and the associated template include the recommendations that apply to test data and information submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or to a test offered as described in an applicable enforcement discretion policy.

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