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

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.