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 In this section:

        Emergency Situations (Medical Devices)

Monkeypox (mpox) and Medical Devices

                        
                FAQs on Testing for Monkeypox (mpox) Home
          Medical Devices
          Medical Device Safety
          Emergency Situations (Medical Devices)
          Monkeypox (mpox) and Medical DevicesEmergency Situations (Medical Devices) Monkeypox (mpox) and Medical Devices
  	
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Information for Monkeypox (mpox) Test Developers
	FDA Cleared and EUA-Authorized Monkeypox (mpox) Tests
	Laboratory Developed Tests
	Lists of Laboratories Offering Notified Laboratory-Developed Monkeypox (mpox) Tests
	Additional InformationMonkeypox (mpox) is an *Orthopoxvirus*. The variola virus, which causes smallpox and has been eradicated globally, is another type of *Orthopoxvirus*. Monkeypox (mpox) is a non-variola *Orthopoxvirus* and is generally not fatal. It typically resolves on its own without treatment. The current outbreak in the U.S. usually presents as a rash on the body, face, or genital area. Although there is a very low risk of death, there have been reported complications including severe pain, at times requiring hospital admission.

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 [mpox] virus.

On the basis of this determination, on September 7, 2022, the Secretary of HHS 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.

Monkeypox (mpox) diagnostic tests are in vitro diagnostic (IVD) devices used to determine if a person is infected with the virus that causes monkeypox (mpox), which is a type of *Orthopoxvirus*. They may detect the virus that causes monkeypox (mpox) specifically or more generally detect non-variola orthopoxviruses, which includes monkeypox (mpox).

Information for Monkeypox (mpox) Test Developers

On September 7, 2022, the FDA issued a guidance, *Policy for Monkeypox  [mpox] Tests to Address the Public Health Emergency*, that describes:

Review priorities of emergency use authorization (EUA) requests for monkeypox (mpox) diagnostic tests,
	Enforcement policies for certain diagnostic tests that are developed by and performed in a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) that meets the requirements to perform tests of high complexity,
	Enforcement policies for FDA-cleared or authorized monkeypox (mpox) diagnostic tests that are modified,
	Enforcement policies for certain serology tests, and
	Recommendations for diagnostic test validation.Answers to FAQs on Testing for Monkeypox (mpox) are also available to assist developers by providing additional clarity on the policies in the guidance.

FDA Cleared and EUA-Authorized Monkeypox (mpox) Tests

Information on Emergency Use Authorizations (EUAs) for in vitro diagnostics that the FDA has issued related to monkeypox (mpox) to address the public health emergency is available on the Monkeypox (mpox) EUAs web page.

Additionally, the Centers for Disease Control and Prevention (CDC) has an FDA-cleared real-time polymerase chain reaction (PCR) testthat detects non-variola Orthopoxvirus DNA, including the virus that causes monkeypox (mpox). The CDC Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (CDC test) is available in designated CDC Laboratory Response Network (LRN) and other CDC-designated laboratories.

HHS has taken several actions to quickly increase monkeypox (mpox) testing capacity and access. In June 2022, HHS, through the CDC, began shipping the CDC test to five commercial laboratory companies. The FDA cleared the use of additional reagents and automation, which helped to increase testing capacity of laboratories using the CDC test.

The CDC test was cleared in 2018 (K181205) for in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA extracted from human pustular or vesicular rash specimens and viral cell culture lysates submitted to an LRN reference laboratory. In 2022, the FDA cleared additional 510(k)s from CDC, which expanded testing capacity through use:

of additional reagents and automation (K221658; cleared on June 10, 2022),
	in CDC-designated laboratories outside the LRN (K221834; cleared on June 24, 2022), and
	of new extraction platform options, among other changes (K222558; cleared on August 30, 2022).Laboratory Developed Tests

In addition to FDA-cleared or EUA-authorized monkeypox (mpox) tests, there are also certain laboratory developed tests (LDTs), that FDA has not reviewed or authorized, that are being used to test for non-variola *Orthopoxvirus* or specifically for monkeypox (mpox). An LDT is a type of in vitro diagnostic test that is designed, manufactured, and used within a single site CLIA-certified laboratory that meets the requirements for high complexity testing.

The FDA has generally exercised enforcement discretion with respect to LDTs, including those developed by hospitals or academic laboratories, meaning that, except in certain circumstances, the FDA generally does not exercise its authority to enforce the regulatory requirements for these devices, although it maintains that authority.

The FDA has not applied this general enforcement discretion approach to tests used for declared emergencies under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In the case of a contagious disease, for example, inaccurate tests can lead to greater spread of the disease and impede the public health response. The FDA, therefore, has generally expected EUAs for LDTs during all prior declared public health emergencies, starting with H1N1 in 2009 and continuing through the COVID-19 emergency. However, in developing policies for specific emergencies, the FDA has considered the national testing needs, availability of cleared or authorized tests, and consequences of a false result, among other factors, and has tailored its specific enforcement discretion policies accordingly.

In line with these considerations, to address current public health needs, the Policy for Monkeypox [mpox] Tests to Address the Public Health Emergency(discussed above), includes enforcement discretion policies for certain monkeypox (mpox) tests developed by laboratories. These policies do not apply to at-home tests, tests with home specimen collection, and tests performed outside of a high-complexity CLIA-certified laboratory. For purposes of the guidance, "high-complexity CLIA-certified laboratories" are referring to single site laboratories that are certified under CLIA that meet the requirements to perform tests of high complexity. The FDA will continue monitoring the developing situation and will evaluate whether we should adjust our policies for LDTs and other tests for monkeypox (mpox) based on the public health needs and taking into account lessons learned from COVID-19.

In the enforcement discretion policies described in the following sections of the guidance, FDA generally expects laboratories to notify the FDA regarding its offering an appropriately validated test:

Section IV.A.2 for monkeypox (mpox) diagnostic tests developed and performed by laboratories,
	Section IV.A.3 for modifications by laboratories to FDA-cleared or EUA-authorized diagnostic tests,
	Section IV.A.4 for notification content for laboratories notifying as described in sections IV.A.2 or IV.A.3, and
	Section IV.C for serology tests that are developed and performed by certain laboratories.Considering the availability and accessibility of monkeypox (mpox) tests, FDA has not been accepting notifications submitted as described in section IV.A.2 of the guidance and received after October 13, 2022, for monkeypox (mpox) diagnostic tests developed and performed in a CLIA-certified laboratory.

To provide transparency, the FDA is posting notification lists that include certain laboratories that have notified the FDA of their laboratory developed monkeypox (mpox) diagnostic test, modification to an FDA-cleared or EUA-authorized monkeypox (mpox) diagnostic test, or laboratory developed monkeypox (mpox) serology test, as described in Sections IV.A.2, IV.A.3, and IV.C, respectively, of the Policy for Monkeypox [mpox] Tests to Address the Public Health Emergency. The lists of notifications include laboratories that have either agreed to be identified on the FDA's website or are currently offering their test. For the list of notifications submitted as described in section IV.A.2 of the guidance, this includes notifications submitted prior to October 14, 2022. The FDA has not reviewed the laboratory's validation of tests offered as described in these policies and has not issued EUAs for these tests.

Note that various laboratories around the country, including public health, commercial, and healthcare system/academic laboratories, are providing testing for monkeypox (mpox) using an FDA-cleared or EUA-authorized monkeypox (mpox) test.

Lists of Laboratories Offering Notified Laboratory-Developed Monkeypox (mpox) Tests

**Notifications as described in Section IV.A.2 of the guidance - Monkeypox [mpox] Diagnostic Tests Developed and Performed by Single-Site High Complexity CLIA-Certified Laboratories**

Laboratory / Manufacturer Name
			Test Name
			Laboratory Location (City, State)Access Medical Laboratories, Inc
			Direct Real-Time PCR Procedure for the Determination of Monkeypox Virus in Clinical Specimens
			Jupiter, FLApostle Diagnostics Apostle Diagnostics
			Monkeypox Real-Time PCR Test
			San Jose, CAApplied DNA Clinical Labs, LLC
			Linea Monkeypox Virus 1.0 Assay
			Stony Brook, NYARUP Laboratories, Inc.
			Orthopoxvirus by PCR
			Salt Lake City, UTASL-DEN, LLC
			Monkeypox Virus PCR; MPXV PCR
			Denver, COBayCare Laboratories, LLC
			Monkeypox Virus PCR
			Tampa, FLBaylor Scott and White Advanced Diagnostics Laboratory
			Altona Realstar Zoonotic Orthopoxvirus Assay
			Temple, TXBeaumont Health
			Monkeypox (Orthopoxvirus) DNA by PCR
			Royal Oak, MIBioReference Health, LLC
			NovaPlex MonkeyPox Assay
			Elmwood Park, NJCalifornia Department of Public Health Viral and Rickettsial Disease Laboratory
			CDPH VRDL Monkeypox Virus Triplex Real-Time PCR Assay
			Richmond, CACenters for Disease Control and Prevention, Poxvirus and Rabies Branch
			CDC Monkeypox Clade I (Congo Basin) Real-Time PCR
			Atlanta, GACenters for Disease Control and Prevention, Poxvirus and Rabies Branch
			CDC Monkeypox Clade II (West African) Real-Time PCR
			Atlanta, GACenters for Disease Control and Prevention, Poxvirus and Rabies Branch
			CDC Monkeypox Generic Real-Time PCR
			Atlanta, GACDR Laboratories, Inc
			Monkeypox Multiplex Assay
			Doral, FLCedars-Sinai Medical Center Department of Pathology and Laboratory Medicine
			Monkeypox Virus, PCR, DNA
			Los Angeles, CACirrusDx, Inc.
			CirrusDx Monkeypox Virus Qualitative Real-Time PCR Assay
			Rockville, MDClinical Reference Laboratory
			Logix SmartTM Monkeypox (MPX) Test
			Lenexa, KSClinical Virology Laboratory, Yale New Haven Hospital
			Monkeypox Virus PCR Test
			New Haven, CTCurative Labs
			MPX Assay
			Washington, DCDepartment of Veterans Affairs Public Health Reference Laboratory (PHRL)
			Monkeypox Confirmation
			Palo Alto, CADevLab Bio
			Monkeypox Real-Time PCR Test
			Coppell, TXDiscover Labs
			Real-Time PCR – Lesion Swabs in UTM/VTM
			Austin, TXEastGene Laboratories, Inc.
			Detection of Monkeypox DNA using Real-time PCR
			Flushing, NYECU Health Medical Center Molecular Microbiology Laboratory
			TaqManTM Monkeypox Virus DNA PCR Assay
			Greenville, NCFulgent Genetics (Fulgent Therapeutics, LLC)
			Monkeypox (Orthopoxvirus) PCR Test
			Temple City, CAHealth First Urgent Care
			Monkeypox Virus (Orthopoxvirus) spp. and Monkeypox Virus (Orthopoxvirus) Congo Basin Clade
			Richland, WAHouston Methodist Hospital Pathology
			Monkeypox Qualitative PCR
			Houston, TXIndiana University Health Pathology Laboratory
			Orthopoxvirus/Monkeypox Virus DNA, PCR
			Indianapolis, INIntegrity Laboratories, LLC
			MPX DX Test
			Knoxville, TNIpsum Diagnostics LLC
			MPX IDx Monkeypox Real-Time PCR Assay
			Atlanta, GAJohns Hopkins Medical Microbiology Laboratory
			Nonvariola Orthopox Test
			Baltimore, MDLSU School of VET MED, Louisiana Animal Disease Diagnostic Laboratory
			Monkeypox Virus Real-Time RT-PCR Test
			Baton Rouge, LAMako Medical
			MPXV
			Henderson, NCMemorial Sloan Kettering Cancer Center's Clinical Microbiology Service, Department of Pathology and Laboratory Medicine
			MSK Monkeypox Virus Generic Real-Time PCR
			New York, NYMidwest Respiratory Virus Program
			MPoxRT
			Milwaukee, WIMirimus, Inc.
			Mirimus MPVX RT-PCR Assay
			Brooklyn, NYMolecular Diagnostics Laboratory, University of Texas Southwestern Medical Center, Dallas
			Monkeypox Qualitative PCR Assay
			Dallas, TXMontefiore Medical Center
			Orthopox/Monkeypox (Dual Target)
			Bronx, NYNationwide Children's Hospital's Clinical Microbiology and Immunoserology Laboratory
			Monkeypox DNA Detection by Real-Time PCR
			Columbus, OHNew York Presbyterian Hospital - Weill Cornell Medicine (NYPH-WCM)
			Monkeypox PCR
			New York, NYNomi Health Laboratory Services LLC
			Logix Smart Monkeypox Test
			Salt Lake City, UTNYU Langone Hospitals Clinical Labs
			Monkeypox Virus DNA, by PCR
			New York, NYParkway Clinical Laboratories, Inc.
			Monkeypox by RT-PCR
			Bensalem, PAPreCheck Health Services, Inc.
			Monkeypox Virus and other Non-Variola Orthopoxviruses Qualitative Real-Time PCR Assay
			Miami, FLProvista Diagnostics
			ANDiS Monkeypox Virus RT-PCR Detection
			Alpharetta, GARadeas
			Radeas MPX Real Time PCR Assay
			Wake Forest, NCRapidBio
			Monkeypox (MPV) Test using MagMAX Viral/Pathogen Nucleic Acid Isolation Kit, DNA Software PCR Assay Kit (MPX1-RPP30DNA)
			Plymouth, MIrenegadexbio, PBC DBA renegade.bio
			Multiplex mqRT-PCR+ Testing for Monkeypox Virus (MPXV) Patient Samples
			Berkeley, CAReOpen Diagnostics, LLC (dba Pandemic Response Laboratory)
			Monkeypox Nucleic Acid Amplification DNA
			Rockville, MDReOpen Diagnostics, LLC (dba Pandemic Response Laboratory)
			Monkeypox Nucleic Acid Amplification DNA
			New York, NYRheonix Laboratories, LLC
			Rheonix Monkeypox PCR Assay
			Ithaca, NYSan Francisco Public Health Laboratory
			Monkeypox Non-Variola Orthopox Virus, Congo Basin and West African Clades Real Time PCR Assay
			San Francisco, CASanta Clara County Public Health Laboratory
			LRN Non-Variola (NVO) PCR
			San Jose, CASanta Clara Valley Medical Center Clinical Laboratory
			SCVMC Monkeypox Virus PCR Diagnostic Assay
			San Jose, CAShepard Health LLC
			Shepard Health MPXV, Monkeypox
			Sandy Springs, GASolaris Diagnostics Laboratory
			Solaris Monkeypox Virus (MPXV)
			Nicholasville, KYSparrow Center for Laboratory Medicine
			Monkeypox by PCR
			Lansing, MITAAG Genetics Corp.
			TAAG CS50 MonkeyPox
			St. Charles, ILTampa General Hospital Clinical Laboratory – Esoteric Testing Department
			Monkeypox Real-Time PCR
			Tampa, FLUAB Fungal Reference Lab
			FRL MPX PCR
			Birmingham, ALUCLA Healthcare Clinical Laboratory-Brentwood
			Non-Variola Orthopoxvirus and West-African Monkeypox Multiplex Real-Time PCR
			Los Angeles, CAUniversity Medical Center of Southern Nevada
			Monkey Pox
			Las Vegas, NVUniversity of North Carolina Medical Center
			Monkeypox (Orthopox) PCR
			Chapel Hill, NCUniversity of Wisconsin Health Clinical Laboratory
			Monkeypox by PCR Test
			Madison, WIUPMC Clinical Virology Laboratory
			UPMC Monkeypox Virus Qualitative Real-Time PCR
			Pittsburgh, PAUptown Providers PC
			DTPM Monkeypox (Orthopoxvirus) RT-PCR Test
			Beaverton, ORUS Army Medical Research Institute of Infectious Diseases (USAMRIID) Special Pathogens Lab (SPL)
			USAMRIID MPXV Real-Time RT-PCR Assay (AAMRIID-MPXV)
			Fort Detrick, MDUS BioTek Laboratories, LLC
			Monkeypox Virus DNA
			Shoreline, WAVanderbilt University Medical Center
			MIDL PCR Monkeypox
			Nashville, TNWadsworth Center, New York State Department of Health
			Monkeypox Virus Clade II (West African clade) Real-Time PCR detection Assay
			Albany, NYXYZ Laboratory
			Monkeypox Virus Real-Time PCR Assay
			Lakeway, TXAlaine Diagnostic, LLC
			AmpFire Monkeypox
			Houston, TXClinical Virology Laboratory at Children’s Hospital Los Angeles
			Monkeypox Virus RT-PCR
			Los Angeles, CAColumbia University, Laboratory of Personalized Genomic Medicine
			Orthopox/Monkeypox PCR
			New York, NYLabQ Clinical Diagnostics—Department of Molecular Diagnostics
			Detection of Monkeypox Using Real Time PCR
			Budd Lake, NJMadison Core Laboratories
			MPXduPLEX
			Huntsville, ALMolecular Diagnostics Laboratory, Pathology Laboratories at the University of Maryland Medical Center
			CDC Developed Non-Variola Orthopoxvirus (E9L-NVAR) Real-Time PCR Test
			Baltimore, MDNeelyx Labs
			Neelyx Labs Monkeypox Virus Qualitative Real-Time PCR Test
			Wood Dale, ILNorthwell Health Laboratories
			Monkeypox Generic PCR
			Lake Success, NYNorthwell Health Laboratories
			Non-Variola Orthopoxvirus PCR
			Lake Success, NYTemple University Health System—Department of Molecular Pathology
			Detection of Monkeypox Using Real Time PCR
			Philadelphia, PAUniversity of California San Diego, Health Center for Advanced Laboratory Medicine, Microbiology Laboratory
			Monkeypox and Non-Variola Orthopoxvirus Qualitative Detection
			San Diego, CAUW Virology Laboratory
			UW Monkeypox Virus Qualitative PCR
			Seattle, WAValley Medical and Wellness
			Monkeypox Screening Assay
			Burnsville, MNWisconsin Diagnostic Laboratories
			Monkeypox Virus Nucleic Acid Amplification Test
			Milwaukee, WIRittenhouse Molecular Laboratory, Department of Pathology and Laboratory Medicine at the University of Pennsylvania
			Orthopoxvirus by PCR
			Philadelphia, PASinochips Kansas LLC, dba, Sinochips Diagnostics
			Monkeypox Virus Real-Time PCR Test
			Olathe, KS

**Notifications as described in Section IV.A.3 of the guidance - Modifications by Single-Site High Complexity CLIA-Certified Laboratories to FDA-cleared or EUA-authorized Monkeypox [mpox] Diagnostic Tests**

Laboratory / Manufacturer Name
			Test Name
			Laboratory Location (City, State)
			Link to Underlying FDA-cleared or EUA-authorized TestWisconsin State Laboratory of Hygiene
			Non-Variola Orthopoxvirus Real-Time PCR for Suspected Infection with Monkeypox Clade II
			Madison, WI
			K222558

The FDA will update this table when information when information becomes available.

**Notifications as described in Section IV.C of the guidance - Monkeypox [mpox] Serology Tests Developed and Performed by Certain Single-Site High Complexity CLIA-Certified Laboratories**

Laboratory / Manufacturer Name
			Test Name
			Laboratory Location (City, State)Centers for Disease Control and Prevention, Poxvirus and Rabies Branch
			CDC ELISA Detection of Orthopoxvirus IgG
			Atlanta, GAWadsworth Center, New York State Department of Health
			New York State Orthopoxvirus (non-Vaccinia virus) Microsphere Immunoassay for IgG Antibody Detection
			Albany, NYCenters for Disease Control and Prevention, Poxvirus and Rabies Branch
			CDC ELISA detection of Orthopoxvirus IgM
			Atlanta, GA

Additional Information

Policy for Monkeypox [mpox] Tests to Address the Public Health Emergency
	Monkeypox (mpox) Emergency Use Authorizations (EUAs) for Medical Devices
	FAQs on Testing for Monkeypox (mpox)
	CDC Mpox: Information for Laboratory Personnel
	For Monkeypox [mpox] Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication
	FDA Mpox Response
	CDC Mpox

                                                                                  Content current as of:
      01/27/2023
                  
                   
Regulated Product(s)
		 Medical DevicesMonkeypox (mpox) and Medical Devices                
                          

                        FAQs on Testing for Monkeypox (mpox)
 
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