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GUIDANCE DOCUMENT

Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency Draft Guidance for Industry and Food and Drug Administration Staff January 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-2707

Docket Number:
FDA-2024-D-2707
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of In Vitro Diagnostics and Radiological Health

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 This draft guidance describes general recommendations for the validation of in vitro diagnostic devices (IVDs) for emerging pathogens during an applicable declaration under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.

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