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        Emergency Use Authorizations for Medical Devices

Monkeypox (mpox) Emergency Use Authorizations for Medical Devices Home
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          Medical Device Safety
          Emergency Situations (Medical Devices)
          Emergency Use Authorizations for Medical Devices
          Monkeypox (mpox) Emergency Use Authorizations for Medical DevicesEmergency Use Authorizations for Medical Devices Monkeypox (mpox) Emergency Use Authorizations for Medical Devices
  	
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    PrintOn 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 [mpox] 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 [mpox] 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 (mpox) tests to address the public health emergency.

On This Page:

Templates for Monkeypox (mpox) EUA Submissions
	Individual EUAs for Molecular Diagnostic Tests for Monkeypox (mpox)
	Monkeypox (mpox) ResourcesTemplates for Monkeypox (mpox) EUA Submissions

Templates for EUA submissions for monkeypox (mpox) 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 [mpox]
	EUA Template for Developers of Molecular Diagnostic Tests for Monkeypox [mpox]
	EUA Summary Template for Developers of Antigen Diagnostic Tests for Monkeypox [mpox]
	EUA Template for Developers of Antigen Diagnostic Tests for Monkeypox [mpox]These templates are part of the FDA's *Policy for Monkeypox [mpox]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 (mpox) and gain experience with the EUA process for the various types of monkeypox (mpox) 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 MPXDx@fda.hhs.gov.

Members of the public can submit questions about the templates to MPXDx@fda.hhs.gov, or they can submit comments regarding the templates to the public docketestablished for the guidance *Policy for Monkeypox [mpox] 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 MPXDx@fda.hhs.gov.

Additional information can be found on the FAQs on Testing for Monkeypox (mpox).

Individual EUAs for Molecular Diagnostic Tests for Monkeypox (mpox)

This table includes information about authorized monkeypox (mpox) 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.

Date EUA Issued or Last Updated
			Entity
			Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued
			Attributes
			Authorized Setting(s)
			Authorization Documents
			Other Documents
			Other Brand Name(s)01/10/2023
			DiaCarta, Inc.
			QuantiVirus MPXV Test Kit
			01/10/2023
			Real-time PCR, Multiple Targets
			H
			HCP, Patients, IFU
			None
			None05/22/2023
			Quest Diagnostics Nichols Institute
			Quest Diagnostics Mpox Virus Qualitative Real-Time PCR (2-well)
			09/07/2022
			Real-time PCR, Multiple Targets
			H
			HCP, Patients, EUA Summary
			Letter Granting EUA Revision (December 9, 2022)
			None07/18/2023
			Abbott Molecular, Inc.
			Alinity m MPXV
			10/07/2022
			Real-time PCR, Multiple Targets
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (July 18, 2023)
			None12/14/2022
			Roche Molecular Systems, Inc.
			cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV)
			11/15/2022
			Real-time PCR, Multiple Targets
			H, M
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (December 14, 2022)
			None03/30/2023
			Cepheid
			Xpert Mpox
			2/10/2023
			Real-time PCR, Multi-analyte, Multiple Targets
			H, M, W
			HCP, Patients, IFU for Labs, IFU for Point-of-Care
			Letter Granting EUA Revision(s) (March 30, 2023)
			None09/19/2023
			Cue Health, Inc.
			Cue Mpox (Monkeypox) Molecular Test
			03/17/2023
			Real-time PCR, Single Target
			H, M, W
			HCP, Patients, IFU
			Letter Granting EUA Revision(s) (September 19, 2023)
			None

Monkeypox (mpox)Resources

Monkeypox (mpox) and Medical Devices
	Policy for Monkeypox [mpox] Tests to Address the Public Health Emergency
	FAQs on Testing for Monkeypox (mpox)

                                                                                  Content current as of:
      09/21/2023
                  
                   
Regulated Product(s)
		 Medical DevicesMonkeypox (mpox) Emergency Use Authorizations for Medical Devices
 
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