Original Post
On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus.
On the basis of this determination, on September 7, 2022, the Secretary of HHS has subsequently declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
This page will be updated to provide new or updated information on the Emergency Use Authorizations (EUAs) for monkeypox tests to address the public health emergency.
On This Page:
- Templates for EUA Submissions
- Individual EUAs for Molecular Diagnostic Tests for Monkeypox
- Monkeypox Resources
Templates for EUA Submissions
Templates for EUA submissions for monkeypox tests are available to help facilitate the preparation, submission, and authorization of an EUA request:
- EUA Summary Template for Developers of Molecular Diagnostic Tests for Monkeypox
- EUA Template for Developers of Molecular Diagnostic Tests for Monkeypox
These templates are part of the FDA’s Policy for Monkeypox Tests to Address the Public Health Emergency, which also includes policies specific to tests for this public health emergency. The templates reflect the FDA’s current thinking on the data and information that 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.
Developers who intend to use alternative approaches should consider seeking the FDA’s feedback or recommendations to help them through the EUA process. The FDA encourages developers to discuss any alternative technological approaches to validating their test with the FDA through submission of a pre-EUA to [email protected].
Members of the public can submit questions about the templates to [email protected], or they can submit comments regarding the templates to the public docket established for the guidance Policy for Monkeypox Tests to Address the Public Health Emergency.
Test developers interested in pursuing an EUA may submit a pre-EUA to begin discussions with the FDA or may submit an EUA request to [email protected].
Additional information can be found on the FAQs on Testing for Monkeypox.
Individual EUAs for Molecular Diagnostic Tests for Monkeypox
This table includes information about authorized monkeypox diagnostic tests. These EUAs have been issued for individual tests with certain conditions of authorization required (e.g., conditions for the test manufacturer, authorized laboratories, etc.). Test attributes are listed in the “Attributes” column. For example, tests that are noted with an “H” in the Authorized Settings are limited to use in laboratories certified under CLIA that meet requirements to perform high-complexity tests. Tests that are noted with an “H” and “M” in the Authorized Settings may be performed in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests. Tests that are noted with a “W” in the Authorized Settings are deemed to be CLIA-waived for use in patient care settings operating under a CLIA Certificate of Waiver. Tests noted with an “H,” “M,” and “W” may be used in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests and in patient care settings operating under a CLIA Certificate of Waiver.
To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the “Date EUA Issued or Last Updated” for the EUA.Search:Show 102550100All entries
| Date EUA Issued or Last Updated | Entity | Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued | Attributes | Authorized Setting(s) | Authorization Documents |
|---|---|---|---|---|---|
| 10/07/2022 | Abbott Molecular, Inc. | Alinity m MPXV 10/07/2022 | Real-time PCR, Multiple Targets | H, M | HCP, Patients, IFU |
| 09/15/2022 | Quest Diagnostics Nichols Institute | Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR 09/07/2022 | Real-time PCR, Multiple Targets | H | HCP, Patients, EUA Summary |
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Monkeypox Resources
