 
Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency. This guidance, when finalized, will provide recommendations for validating certain in vitro diagnostic devices (IVDs) intended to detect new or unusual biological agents during a declared emergency applicable to IVDs under section 564 of the Federal Food, Drug, and Cosmetic Act. It applies to test data and information submitted in an Emergency Use Authorization (EUA) request, pre-EUA request, or to a test offered as described in an applicable enforcement discretion policy.
Manufacturers must ensure their diagnostic tests are appropriately validated. This includes tests intended to diagnose serious or life-threatening diseases caused by emerging pathogens or unusual presentations of known agents. A generic template reflecting the FDA’s current thinking on validation study recommendations, and data and information that should be submitted in pre-EUAs and EUA requests, is available for download from the FDA’s website.
Note: This guidance is not for implementation at this time.
Submit comments on this draft guidance
Submit comments under docket number FDA-2024-D-2707 at www.regulations.gov by March 7, 2025 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Questions?
If you have questions about this draft guidance, contact IVDguidance@fda.hhs.gov.
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