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  1. Emergency Situations (Medical Devices)

Monkeypox (mpox) and Medical Devices

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Monkeypox (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) test that 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, FL
Apostle Diagnostics Apostle Diagnostics Monkeypox Real-Time PCR Test San Jose, CA
Applied DNA Clinical Labs, LLC Linea Monkeypox Virus 1.0 Assay Stony Brook, NY
ARUP Laboratories, Inc. Orthopoxvirus by PCR Salt Lake City, UT
ASL-DEN, LLC Monkeypox Virus PCR; MPXV PCR Denver, CO
BayCare Laboratories, LLC Monkeypox Virus PCR Tampa, FL
Baylor Scott and White Advanced Diagnostics Laboratory Altona Realstar Zoonotic Orthopoxvirus Assay Temple, TX
Beaumont Health Monkeypox (Orthopoxvirus) DNA by PCR Royal Oak, MI
BioReference Health, LLC NovaPlex MonkeyPox Assay Elmwood Park, NJ
California Department of Public Health Viral and Rickettsial Disease Laboratory CDPH VRDL Monkeypox Virus Triplex Real-Time PCR Assay Richmond, CA
Centers for Disease Control and Prevention, Poxvirus and Rabies Branch CDC Monkeypox Clade I (Congo Basin) Real-Time PCR Atlanta, GA
Centers for Disease Control and Prevention, Poxvirus and Rabies Branch CDC Monkeypox Clade II (West African) Real-Time PCR Atlanta, GA
Centers for Disease Control and Prevention, Poxvirus and Rabies Branch CDC Monkeypox Generic Real-Time PCR Atlanta, GA
CDR Laboratories, Inc Monkeypox Multiplex Assay Doral, FL
Cedars-Sinai Medical Center Department of Pathology and Laboratory Medicine Monkeypox Virus, PCR, DNA Los Angeles, CA
CirrusDx, Inc. CirrusDx Monkeypox Virus Qualitative Real-Time PCR Assay Rockville, MD
Clinical Reference Laboratory Logix Smart™ Monkeypox (MPX) Test Lenexa, KS
Clinical Virology Laboratory, Yale New Haven Hospital Monkeypox Virus PCR Test New Haven, CT
Curative Labs MPX Assay Washington, DC
Department of Veterans Affairs Public Health Reference Laboratory (PHRL) Monkeypox Confirmation Palo Alto, CA
DevLab Bio Monkeypox Real-Time PCR Test Coppell, TX
Discover Labs Real-Time PCR – Lesion Swabs in UTM/VTM Austin, TX
Division of Consolidated Laboratory Services Mpox Diagnostic Real Time PCR Richmond, VA
EastGene Laboratories, Inc. Detection of Monkeypox DNA using Real-time PCR Flushing, NY
ECU Health Medical Center Molecular Microbiology Laboratory TaqMan™ Monkeypox Virus DNA PCR Assay Greenville, NC
Fulgent Genetics (Fulgent Therapeutics, LLC) Monkeypox (Orthopoxvirus) PCR Test Temple City, CA
Health First Urgent Care Monkeypox Virus (Orthopoxvirus) spp. and Monkeypox Virus (Orthopoxvirus) Congo Basin Clade Richland, WA
Houston Methodist Hospital Pathology Monkeypox Qualitative PCR Houston, TX
Indiana University Health Pathology Laboratory Orthopoxvirus/Monkeypox Virus DNA, PCR Indianapolis, IN
Integrity Laboratories, LLC MPX DX Test Knoxville, TN
Ipsum Diagnostics LLC MPX IDx Monkeypox Real-Time PCR Assay Atlanta, GA
Johns Hopkins Medical Microbiology Laboratory Nonvariola Orthopox Test Baltimore, MD
LSU School of VET MED, Louisiana Animal Disease Diagnostic Laboratory Monkeypox Virus Real-Time RT-PCR Test Baton Rouge, LA
Mako Medical MPXV Henderson, NC
Memorial Sloan Kettering Cancer Center's Clinical Microbiology Service, Department of Pathology and Laboratory Medicine MSK Monkeypox Virus Generic Real-Time PCR New York, NY
Midwest Respiratory Virus Program MPoxRT Milwaukee, WI
Mirimus, Inc. Mirimus MPVX RT-PCR Assay Brooklyn, NY
Molecular Diagnostics Laboratory, University of Texas Southwestern Medical Center, Dallas Monkeypox Qualitative PCR Assay Dallas, TX
Montefiore Medical Center Orthopox/Monkeypox (Dual Target) Bronx, NY
Nationwide Children's Hospital's Clinical Microbiology and Immunoserology Laboratory Monkeypox DNA Detection by Real-Time PCR Columbus, OH
New York Presbyterian Hospital - Weill Cornell Medicine (NYPH-WCM) Monkeypox PCR New York, NY
NYU Langone Hospitals Clinical Labs Monkeypox Virus DNA, by PCR New York, NY
Parkway Clinical Laboratories, Inc. Monkeypox by RT-PCR Bensalem, PA
PreCheck Health Services, Inc. Monkeypox Virus and other Non-Variola Orthopoxviruses Qualitative Real-Time PCR Assay Miami, FL
Provista Diagnostics ANDiS Monkeypox Virus RT-PCR Detection Alpharetta, GA
Radeas Radeas MPX Real Time PCR Assay Wake Forest, NC
RapidBio Monkeypox (MPV) Test using MagMAX Viral/Pathogen Nucleic Acid Isolation Kit, DNA Software PCR Assay Kit (MPX1-RPP30DNA) Plymouth, MI
renegadexbio, PBC DBA renegade.bio Multiplex mqRT-PCR+ Testing for Monkeypox Virus (MPXV) Patient Samples Berkeley, CA
ReOpen Diagnostics, LLC (dba Pandemic Response Laboratory) Monkeypox Nucleic Acid Amplification DNA Rockville, MD
ReOpen Diagnostics, LLC (dba Pandemic Response Laboratory) Monkeypox Nucleic Acid Amplification DNA New York, NY
Rheonix Laboratories, LLC Rheonix Monkeypox PCR Assay Ithaca, NY
San Francisco Public Health Laboratory Monkeypox Non-Variola Orthopox Virus, Congo Basin and West African Clades Real Time PCR Assay San Francisco, CA
Santa Clara County Public Health Laboratory LRN Non-Variola (NVO) PCR San Jose, CA
Santa Clara Valley Medical Center Clinical Laboratory SCVMC Monkeypox Virus PCR Diagnostic Assay San Jose, CA
Shepard Health LLC Shepard Health MPXV, Monkeypox Sandy Springs, GA
Solaris Diagnostics Laboratory Solaris Monkeypox Virus (MPXV) Nicholasville, KY
Sparrow Center for Laboratory Medicine Monkeypox by PCR Lansing, MI
TAAG Genetics Corp. TAAG CS50 MonkeyPox St. Charles, IL
Tampa General Hospital Clinical Laboratory – Esoteric Testing Department Monkeypox Real-Time PCR Tampa, FL
UAB Fungal Reference Lab FRL MPX PCR Birmingham, AL
UCLA Healthcare Clinical Laboratory-Brentwood Non-Variola Orthopoxvirus and West-African Monkeypox Multiplex Real-Time PCR Los Angeles, CA
University Medical Center of Southern Nevada Monkey Pox Las Vegas, NV
University of North Carolina Medical Center Monkeypox (Orthopox) PCR Chapel Hill, NC
University of Wisconsin Health Clinical Laboratory Monkeypox by PCR Test Madison, WI
UPMC Clinical Virology Laboratory UPMC Monkeypox Virus Qualitative Real-Time PCR Pittsburgh, PA
Uptown Providers PC DTPM Monkeypox (Orthopoxvirus) RT-PCR Test Beaverton, OR
US Army Medical Research Institute of Infectious Diseases (USAMRIID) Special Pathogens Lab (SPL) USAMRIID MPXV Real-Time RT-PCR Assay (AAMRIID-MPXV) Fort Detrick, MD
US BioTek Laboratories, LLC Monkeypox Virus DNA Shoreline, WA
Vanderbilt University Medical Center MIDL PCR Monkeypox Nashville, TN
Wadsworth Center, New York State Department of Health Monkeypox Virus Clade II (West African clade) Real-Time PCR detection Assay Albany, NY
XYZ Laboratory Monkeypox Virus Real-Time PCR Assay Lakeway, TX
Alaine Diagnostic, LLC AmpFire Monkeypox Houston, TX
Clinical Virology Laboratory at Children’s Hospital Los Angeles Monkeypox Virus RT-PCR Los Angeles, CA
Columbia University, Laboratory of Personalized Genomic Medicine Orthopox/Monkeypox PCR New York, NY
LabQ Clinical Diagnostics—Department of Molecular Diagnostics Detection of Monkeypox Using Real Time PCR Budd Lake, NJ
Madison Core Laboratories MPXduPLEX Huntsville, AL
Molecular Diagnostics Laboratory, Pathology Laboratories at the University of Maryland Medical Center CDC Developed Non-Variola Orthopoxvirus (E9L-NVAR) Real-Time PCR Test Baltimore, MD
Neelyx Labs Neelyx Labs Monkeypox Virus Qualitative Real-Time PCR Test Wood Dale, IL
Northwell Health Laboratories Monkeypox Generic PCR Lake Success, NY
Northwell Health Laboratories Non-Variola Orthopoxvirus PCR Lake Success, NY
Temple University Health System—Department of Molecular Pathology Detection of Monkeypox Using Real Time PCR Philadelphia, PA
University of California San Diego, Health Center for Advanced Laboratory Medicine, Microbiology Laboratory Monkeypox and Non-Variola Orthopoxvirus Qualitative Detection San Diego, CA
UW Virology Laboratory UW Monkeypox Virus Qualitative PCR Seattle, WA
Valley Medical and Wellness Monkeypox Screening Assay Burnsville, MN
Wisconsin Diagnostic Laboratories Monkeypox Virus Nucleic Acid Amplification Test Milwaukee, WI
Rittenhouse Molecular Laboratory, Department of Pathology and Laboratory Medicine at the University of Pennsylvania Orthopoxvirus by PCR Philadelphia, PA
Sinochips Kansas LLC, dba, Sinochips Diagnostics Monkeypox Virus Real-Time PCR Test Olathe, KS
Washington State Public Health Laboratory Clade Specific Mpox Virus Multiplex Real-time PCR Assay Shoreline, WA

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 Test
Wisconsin 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, GA
Wadsworth Center, New York State Department of Health New York State Orthopoxvirus (non-Vaccinia virus) Microsphere Immunoassay for IgG Antibody Detection Albany, NY
Centers for Disease Control and Prevention, Poxvirus and Rabies Branch CDC ELISA detection of Orthopoxvirus IgM Atlanta, GA

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