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Today, the U.S. Food and Drug Administration (FDA) posted the following templates with recommendations on what to include in Emergency Use Authorization (EUA) requests or Pre-EUA submissions for monkeypox antigen tests.
- EUA Summary Template for Developers of Antigen Diagnostic Tests for Monkeypox
- EUA Template for Developers of Antigen Diagnostic Tests for Monkeypox
These templates reflect the FDA's current thinking on the data and information that test developers should submit to facilitate the EUA process. The templates provide information and recommendations, and we plan to update them as appropriate as we learn more about monkeypox and gain experience with the EUA process for the various types of monkeypox tests.
The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.
Questions?
If you have questions about the templates, please email MPXDX@fda.hhs.gov.
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