U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Emergency Preparedness and Response
  3. Public Health Preparedness and Response
  4. Medical Countermeasures (MCMs)
  5. MCM Legal, Regulatory and Policy Framework
  6. Emergency Use Authorization
  1. MCM Legal, Regulatory and Policy Framework

Emergency Use Authorization

Image
Emergency sign

Español

About Emergency Use Authorizations (EUAs)

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.

Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below.

Information on terminated and revoked EUAs can be found in archived information.

Public Readiness and Emergency Preparedness Act (PREP Act) 

Information on the PREP Act can be found here.

The PREP Act amended the Public Health Service Act (PHS Act) to add section 319F-3 (42 U.S.C. 247d-6d).  The HHS Secretary has issued several Declarations pursuant to section 319F-3 of the PHS Act to provide liability immunity for activities related to medical countermeasures against COVID-19. 

PREP Act - COVID-19 Related Information

On May 9, 2023, HHS Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The Secretary issued this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024.

Additional resources:

Guidance

In January 2017, FDA finalized the guidance: Emergency Use Authorization of Medical Products and Related Authorities. For more information, please see the January 13, 2017 Federal Register notice.

Printable PDF (288 KB)

In addition, in January 2014, FDA issued a question and answer document (PDF, 762K) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies.

Coronavirus Disease 2019 (COVID-19) EUA Information

FDA expects the COVID-19 public health emergency (PHE) declared by the Department of Health and Human Services under the Public Health Service Act to expire on May 11, 2023. The ending of the COVID-19 PHE will not impact FDA's ability to authorize medical countermeasures for emergency use. Existing COVID-19 EUAs will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so. Read more about what happens to EUAs when a public health emergency ends.

Vaccines

The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.

For additional information about COVID-19 vaccines, see:

Note: In the table below, the Additional Information column contains links to information including fact sheets, EUA letters of authorization, regulatory information, decision memos, health care provider information, and Federal Register notices.

Date of First EUA IssuanceProductAuthorized UseAdditional Information
07/13/2022Novavax COVID-19 Vaccine, AdjuvantedFor the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older

More information about the Novavax COVID-19 Vaccine

Novavax COVID-19 Vaccine, Adjuvanted decision memos and regulatory documents (ZIP file)

12/18/2020Moderna COVID-19 Vaccine 

For the prevention of 2019 coronavirus disease (COVID-19) in individuals 6 months and older

On January 31, 2022, FDA approved the Moderna COVID-19 Vaccine, now known as Spikevax, for the prevention of COVID-19.

More information about the Moderna COVID-19 Vaccine

Moderna COVID-19 Vaccine decision memos and regulatory documents (ZIP file)

12/11/2020Pfizer-BioNTech COVID-19 Vaccine

For the prevention of 2019 coronavirus disease (COVID-19) in individuals 6 months and older

On August 23, 2021, FDA approved the Pfizer-BioNTech COVID-19 Vaccine, now known as Comirnaty, for the prevention of COVID-19.

More information about the Pfizer-BioNTech COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine decision memos and regulatory documents (ZIP file)

Convalescent Plasma

The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUA subsequently issued by FDA is listed in the table below this blue box.

Also see: Recommendations for Investigational COVID-19 Convalescent Plasma

Date of First EUA IssuanceMost Recent Letter of Authorization (PDF)Authorized UseFact Sheets and Manufacturer Instructions/Package Insert (PDF)Federal Register Notice for EUA
08/23/2020

COVID-19 convalescent plasma (365KB) (Reissued February 23, 2021, March 9, 2021 and December 28, 2021)

Letter Granting EUA Amendment (June 2, 2021) (107KB)

Letter Granting EUA Amendment (February 9, 2022) (26KB)

 

COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies is authorized for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment, in inpatient or outpatient settings.

Healthcare Providers (Updated December 28, 2021) (192KB)

Patients and Parents/ Caregivers (Updated December 28, 2021) (151KB)

Decision Memorandum (166KB)

Decision Memorandum (December 27, 2021) (242KB)
 

 

Drugs and Non-Vaccine Biological Products

View the list Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products, for additional information including letters of authorization, fact sheets, Dear Health Care Provider letters, and additional information about COVID-19 therapeutics.

The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table on the page: Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products.

View the FDA’s COVID-19 Drugs page to see all products approved to treat COVID-19 without any remaining EUA authorized uses.

Revocation notices for COVID-19 drug and biological product EUAs are available at: Emergency Use Authorization--Archived Information.

Related links:

 

Information About COVID-19 EUAs for Medical Devices

Information about COVID-19 EUAs for medical devices can be found below and at: Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.

Transition guidances update

March 24, 2023 - The FDA finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA’s recommendations for: 

  • Developing a transition implementation plan, 
  • Submitting a marketing submission, and 
  • Taking other actions with respect to these devices.

The FDA encourages stakeholders to review the two final guidances, attend the webinar noted below, and reach out to the FDA if they have questions. In particular, for manufacturers that are planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.

Additional resources:

Declaration and determination

On February 4, 2020, the Secretary determined pursuant to section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV).

On the basis of this determination, the HHS Secretary issued three declarations related to medical devices:

For identification of the applicable declaration for each EUA, please see each EUA letter of authorization and/or the corresponding Federal Register notice.

Please see the page In Vitro Diagnostics EUAs for information about in vitro diagnostics EUAs, including templates.

For current SARS-CoV-2 in vitro diagnostic EUAs, see:

On February 29, 2020, the FDA issued an immediately in effect guidance with policy specific to development of in vitro diagnostic tests during this public health emergency. This guidance was updated on March 16, 2020, May 4, 2020, and May 11, 2020. On September 27, 2022, FDA updated this policy to ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways. The updated policy describes the FDA’s intent to review only a small subset of new EUA requests for diagnostic tests and encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways.

CDC has granted a right of reference to the performance data contained in CDC's EUA (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.

For additional information, see Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), FAQs on Diagnostic Testing for SARS-CoV-2, EUA Authorized Serology Test Performance, and CLIA and University Laboratory Testing FAQ (CMS).

For a list of all molecular SARS-CoV-2 diagnostic tests that have been cleared or granted De Novo classification, see devices with product codes QOF and QQX in FDA’s medical devices databases for 510(k) and De Novo. For a list of all antigen SARS-CoV-2 diagnostic tests that have been cleared or granted De Novo classification, see devices with product code QVF in FDA’s medical devices databases for 510(k) and De Novo. For a list of all SARS-CoV-2 serology tests that have been cleared or granted De Novo classification, see devices with product code QVP in FDA’s medical devices databases for 510(k) and De Novo.

Please see the page Personal Protective Equipment EUAs for current EUAs.

For additional information, see Recent Final Medical Device Guidance Documents, and Non-NIOSH Approved Respirator FAQ.

See Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators and Decontamination and Bioburden Reduction Systems below for information about June 30, 2021 EUA revocations. 

Please see the following pages for EUA templates and additional information about other types of medical device EUAs for COVID-19:

On June 30, 2021, the FDA announced the revocation of the following EUAs:

As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings.

For additional information, please see Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities [ARCHIVED]. 
Historical information regarding these EUAs can be found on Historical Information about Device Emergency Use Authorizations and Emergency Use Authorization--Archived Information. 

back to About EUAs

mpox EUA Information

mpox Vaccine EUAs

On November 28, 2022, the World Health Organization announced, and the U.S. government supported, renaming monkeypox disease to mpox. In response to this action by the WHO, federal public health agencies will adopt the mpox name in correspondence with the medical community and American public from this point forward.

Effective August 9, 2022, pursuant to section 564 of the FD&C Act, the HHS Secretary declared:

  • There is a public health emergency related to monkeypox, or significant potential for a public health emergency, that affects, or has the significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus; and  
  • On the basis of this determination, circumstances exist justifying the authorization of emergency use of vaccines.

Vaccine EUAs subsequently issued by FDA are listed in the table below.

PREP Act declaration: Effective September 28, 2022, the HHS Secretary amended the declaration first issued on October 10, 2008, and amended and republished effective January 1, 2016 for smallpox countermeasures and countermeasures against other orthopoxviruses pursuant to section 319F-3 of the Public Health Service Act to emphasize that the declaration applies to monkeypox virus, to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox (variola virus), monkeypox virus, and other orthopoxviruses in a declared emergency, and to extend the duration of the declaration. About PREP Act declarations

Date of First EUA IssuanceLetter of Authorization (PDF)Authorized UseFact Sheets and Manufacturer Instructions/Package Insert  (PDF)Additional Information and Decision Memoranda (PDF)Federal Register Notice for EUA
August 9, 2022

Jynneos (283KB) (reissuance December 23, 2024)

Letter granting EUA amendment (August 16, 2022) (133KB)

  • Active immunization by subcutaneous injection for prevention of monkeypox disease in individuals less than 18 years of age determined to be at high risk for monkeypox infection, and
  • Active immunization by intradermal injection for prevention of monkeypox disease in individuals 18 years of age and older determined to be at high risk for monkeypox infection.

Healthcare Providers (391KB) (updated December 23, 2024)

Recipients and Caregivers (171KB) (updated December 23, 2024)

Dear Healthcare Provider Letter (290KB)

Decision Memorandum (295KB) (August 9, 2022)

Decision Memorandum (347KB) (December 23, 2024)

Authorization of Emergency Use of a Biological Product in Response to an Outbreak of Monkeypox; Availability (October 7, 2022)

mpox In Vitro Diagnostics EUAs

Effective September 7, 2022, pursuant to section 564 of the FD&C Act, the HHS Secretary declared: 

  • On the basis of the August 9th determination, 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. See from HHS: HHS Secretary Becerra Issues 564 Declaration to Expand the Availability of Testing for Monkeypox

Diagnostic EUAs subsequently issued by FDA are listed in the table on this page: Monkeypox Emergency Use Authorizations for Medical Devices.

Additional information for product developers is available at:

Note that FDA previously cleared real-time polymerase chain reaction (PCR) tests that detect non-variola orthopoxvirus DNA, including the virus that causes mpox. Learn more about these tests: Monkeypox Tests (In Vitro Diagnostic (IVD) Devices). 

Date of First EUA IssuanceAdditional InformationFederal Register Notices
September 7, 2022

On October 20, 2022, FDA also published lists of certain laboratories that have notified FDA of their laboratory developed monkeypox diagnostic test (LDT), modification to an FDA-cleared or EUA-authorized monkeypox diagnostic test, or laboratory developed monkeypox serology test, as described in Sections IV.A.2, IV.A.3, and IV.C, respectively, of the Policy for Monkeypox Tests to Address the Public Health Emergency. While FDA has not reviewed the laboratory’s validation of the listed tests and has not issued EUAs for these tests, we are providing this information to promote transparency. 

For additional information about monkeypox (mpox), see: FDA mpox Response and Monkeypox and Medical Devices.

back to About EUAs

Other Current EUAs

The tables below provide information on current EUAs:

Information about EUAs that are no longer in effect is available on our EUA archive page.

back to top of page 

The 2016 FDA Doxycycline Emergency Dispensing Order and CDC Doxycycline Emergency Use Instructions (EUI) together replace the need for the doxycycline mass dispensing EUA (issued on July 21, 2011). Therefore, the doxycycline emergency dispensing order and EUI should be used by stakeholders for anthrax preparedness and response instead of the mass dispensing EUA.

The July 21, 2011, doxycycline mass dispensing EUA, and the October 14, 2011, National Postal Model anthrax EUA will be terminated by FDA, and notice of such termination will be published in the Federal Register. For additional information, see Emergency Use Authorization--Archived Information.

back to list of current EUAs

Ebola preparedness and response updates from FDA (all agency activities)

For more information about the diagnostics below, also see Emergency Use Authorizations for Medical Devices: 2014 Ebola Virus Emergency Use Authorizations.

Ebola Diagnostic Tests with De Novo, 510(k) or PMA

  • OraQuickEbola Rapid Antigen Test - On October 10, 2019, FDA allowed marketing (PDF, 255 KB) of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for Ebola virus disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed. Also see the FDA news release: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens

    The OraQuick Ebola Test was reviewed under the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this marketing authorization, the FDA is establishing criteria, called special controls, that determine the requirements for demonstrating accuracy, reliability and effectiveness of tests intended to identify Ebola virus antigens. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and Manufacturer Instructions/Package InsertEUA Determination and Declaration (Effective Date)PREP Act Declaration (if applicable)
EZ1 Real-time RT-PCR Assay 
(DoD)

August 5, 2014 (initial issuance)

October 10, 2014 (reissuance)

 

Authorization (PDF, 61 KB) FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) 
CDC Ebola Virus NP Real-time RT-PCR Assay 
(CDC)

October 10, 2014 (initial issuance) 

March 2, 2015 (reissuance)

October 8, 2019 (amended)

 

Authorization (PDF, 282 KB)

Letter granting EUA amendment(s) (PDF, 134 KB)

 FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) 
CDC Ebola Virus VP40 Real-time RT-PCR Assay 
(CDC)

October 10, 2014 (initial issuance) 

March 2, 2015 (reissuance)

October 8, 2019 (amended)

 

Authorization (PDF, 285 KB)

Letter granting EUA amendment(s) (PDF, 135 KB)

FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) 
FilmArray Biothreat-E test 
(Biofire Defense, LLC)

October 25, 2014 

November 12, 2019 (amended) 

Authorization (PDF,  73 KB)       

Letter granting EUA amendment(s) (PDF, 152 KB)

FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) 
RealStar Ebolavirus RT-PCR Kit 1.0 
(altona Diagnostics, GmbH)

November 10, 2014 (initial issuance)

November 26, 2014 (reissuance)  

 

Authorization (PDF,  263 KB)FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) 
LightMix Ebola Zaire rRT-PCR Test 
(Roche Molecular Systems, Inc.)		December 23, 2014Authorization (PDF,  2.2 MB) FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) 
Xpert Ebola Assay
(Cepheid)

March 23, 2015

June 13, 2023 (amended)

Authorization (PDF,  240 KB)

Letter Granting EUA Amendments (PDF, 171 KB)

FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) 
DPP Ebola Antigen System (Chembio Diagnostic Systems, Inc.)

November 9, 2018

April 2, 2019 (amended)

Authorization  (PDF,  103 KB)

Letter Granting EUA Amendment(s) (PDF, 87 KB)

FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) 

 

back to list of current EUAs

Also see FDA News Release: FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product (July 10, 2018)

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and Manufacturer Instructions/Package InsertEUA Determination and Declaration (Effective Date)PREP Act Declaration (if applicable)
octaplas LGPowder (Octapharma Pharmazeutika Produktionsges.m.b.H.)August 8, 2024 (issuance)Authorization (PDF,  540KB)FR notice

Determination by DoD (June 7, 2018)

Declaration Regarding Emergency Use of Treatment for Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat (July 9, 2018)

 

Pathogen-Reduced Leukocyte-Depleted Freeze Dried Plasma (Centre de Transfusion Sanguine des Armées)

 

July 9, 2018 (initial issuance)

May 8, 2020 (amendment)

August 29, 2023

Authorization (PDF,  203 KB)

Letter granting EUA amendments (PDF, 60 KB)

Letter granting EUA amendments (PDF, 133 KB)

FR notice

Determination by DoD (June 7, 2018)

Declaration Regarding Emergency Use of Treatment for Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat (July 9, 2018)

 

back to list of current EUAs

For more information about the diagnostics below, also see Emergency Use Authorizations for Medical Devices: 2013 H7N9 Influenza Emergency Use Authorization (Potential Emergency).

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheet and Manufacturer Instructions/Package InsertEUA Determination and Declaration (Effective Date)PREP Act Declaration (if applicable) 
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay
 

April 22, 2013 (initial issuance)

 

March 27, 2018 (reissuance)

Authorization  (PDF, 301 KB), re-issued March 27, 2018

 

FR notice

Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013)

Amended Determination of a Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b) (July 18, 2024)

Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.)
Quidel Lyra Influenza A Subtype H7N9 AssayFebruary 14, 2014Authorization (PDF, 57 KB)FR notice

Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013)

Amended Determination of a Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b) (July 18, 2024)

Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.)
A/H7N9 Influenza Rapid TestApril 25, 2014AuthorizationFR notice

Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013)

Amended Determination of a Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b) (July 18, 2024)

Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.)

back to list of current EUAs

For more information about the diagnostics below, also see Emergency Use Authorizations for Medical Devices: 2013 Coronavirus Emergency Use Authorization (Potential Emergency).

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and Manufacturer Instructions/Package InsertEUA Determination and Declaration (Effective Date)PREP Act Declaration (if applicable)
CDC Novel Coronavirus 2012 Real-time RT-PCR Assay

June 5, 2013 (initial issuance)

June 10, 2014 (reissuance)

June 24, 2024 (reissuance)

Authorization (PDF, 2.2 MB)FR noticeDetermination and Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) (May 29, 2013) 
RealStar MERS-CoV RT-PCR Kit U.S.

July 17, 2015
(initial issuance)

February 12, 2016 (reissuance)

 

 

Authorization (PDF, 238 KB)FR noticeDetermination and Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) (May 29, 2013) 

back to list of current EUAs

On July 9, 2018, FDA approved (PDF,  49 KB) the 2 mg Atropine Auto-Injector manufactured by Rafa Laboratories, Ltd., for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides in adults and pediatric patients weighing over 90 lbs [41 kg] (generally over 10 years of age). For more information about the approved 2 mg Rafa Atropine Auto-Injector, see the product label (PDF, 482 KB). The EUA detailed in the table below is still in effect.

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and Manufacturer Instructions/Package InsertEUA Determination and Declaration (Effective Date)PREP Act Declaration (if applicable)
Atropine Auto-Injector (Rafa Laboratories Ltd.)

April 11, 2017 (initial issuance)

May 23, 2017 (amended)

January 24, 2018 (amended)

March 6, 2018 (amended)

May 15, 2018 (amended)

Letter of Authorization (PDF,  514 KB)

Letter granting EUA amendment(s) (PDF, 28 KB)

2nd letter granting EUA amendment(s) (PDF, 33 KB)

3rd letter granting EUA amendment(s) (PDF, 85 KB)

4th letter granting EUA amendment(s) (PDF, 42 KB)

FR
notice
 		Determination and Declaration Regarding Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning (April 11, 2017)Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures (April 11, 2017)

back to list of current EUAs

Zika virus response updates from FDA

For more information about the diagnostics below, also see Emergency Use Authorizations for Medical Devices: Zika Virus Emergency Use Authorization.

Draft EUA review templates for Zika are available by email request to: CDRH-ZIKA-Templates@fda.hhs.gov

Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.

Zika Diagnostic Tests with De Novo, 510(k), or PMA

  • ZIKV Detect 2.0 IgM Capture ELISA - On May 23, 2019, FDA authorized marketing (PDF, 175 KB) of the ZIKV Detect 2.0 IgM Capture ELISA to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S.; previously, tests for detecting Zika virus IgM antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—had been authorized only for emergency use under the FDA’s EUA authority. Also see the FDA news release: FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
  • ADVIA Centaur Zika test – On July 17, 2019, FDA cleared the ADVIA Centaur Zika test. This is the second Zika diagnostic test FDA has allowed to be marketed in the U.S. for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.
  • LIAISON XL Zika Capture IgM Assay II – On October 28, 2019, FDA cleared the LIAISON XL Zika Capture IgM Assay II for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.
  • DPP Zika IgM Assay System – On June 3, 2020, FDA cleared a similar DPP Zika IgM System for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.
Medical ProductDate of EUA IssuanceLettersFederal Register Notice for EUAFact Sheets and Manufacturer Instructions/Package InsertEUA Determination and Declaration (Effective Date)PREP Act Declaration (if applicable)

CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay

CDC statement on this EUA [ARCHIVED]

February 26, 2016 (initial issuance)

June 29, 2016 (amended)

November 15, 2016 (amended)

December 6, 2016 (amended)

May 3, 2017 (amended)

July 31, 2017 (amended)

April 16, 2018 (amended)

September 26, 2018 (amended)

October 5, 2021 (amended)

September 27, 2023 (reissuance)

Authorization (PDF, 329 KB)

Letter granting EUA amendment(s) (PDF, 155 KB)

Letter granting EUA amendment(s) (PDF, 123 KB)

Letter granting EUA amendment(s) (PDF, 110 KB)

Letter granting EUA amendment(s) (PDF, 113 KB)

Letter granting EUA amendment(s) (PDF, 131 KB)

Letter granting EUA amendment(s) (PDF, 131 KB)

FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 

CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR)

CDC statement on this EUA [ARCHIVED]

March 17, 2016 (initial issuance)

September 21, 2016 (amended)

January 12, 2017 (amended)

February 28, 2017 (amended)

April 6, 2017 (amended)

February 26, 2021 (amended)

Authorization (PDF, 82 KB)

Letter granting EUA amendment(s) (PDF, 223 KB)

Letter granting EUA amendment(s) (PDF, 223 KB)

Letter granting EUA amendment(s) (PDF, 223 KB)

Letter granting EUA amendment(s) (PDF, 126 KB)

Letter granting EUA amendment(s) (PDF, 143 KB)

 FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 
Zika Virus RNA Qualitative Real-Time RT-PCR (Quest Diagnostics Infectious Disease, Inc.)

April 28, 2016 (initial issuance)

October 7, 2016 (reissuance)

April 11, 2017 (amended)

Authorization  (PDF, 339 KB)

Letter granting EUA amendment(s) (PDF, 126 KB)

FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 
RealStar Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH)

May 13, 2016 (initial issuance)

October 31, 2016 (amended)

March 6, 2017 (amended)

Authorization (PDF, 342 KB)

Letter Granting EUA Amendment(s) (PDF, 130 KB)

Letter Granting EUA Amendment(s) (PDF, 130 KB)

FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 
Aptima Zika Virus assay (Hologic, Inc.)

June 17, 2016 (initial issuance)

September 7, 2016 (amended)

April 12, 2017 (amended)

March 8, 2018 (amended)

August 24, 2023 (amended)

 

Authorization (PDF, 305 KB)

Letter granting EUA amendment(s) (PDF, 126 KB)

Letter granting EUA amendment(s) (PDF, 124 KB)

Letter granting EUA amendment(s) (PDF, 130 KB)

Letter granting EUA amendment(s) (PDF, 130 KB)

 

 FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 
Zika Virus Real-time RT-PCR Test (Viracor Eurofins)

July 19, 2016 (initial issuance)

February 28, 2017 (amended)

October 5, 2021 (amended)

Authorization (PDF, 334 KB)

Letter granting EUA amendment(s) (PDF, 124 KB)

FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 
VERSANT Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics Inc.)

July 29, 2016 (initial issuance)

December 19, 2016 (amended)

Authorization (PDF, 78 KB)

Letter granting EUA amendment(s) (PDF, 124 KB)

FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 
Sentosa SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.)September 23, 2016Authorization (PDF,  355 KB)FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 
Zika Virus Detection by RT-PCR Test (ARUP Laboratories)

September 28, 2016

October 5, 2021 (amended)

Authorization (PDF,  98 KB)FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 
Abbott RealTime ZIKA (Abbott Molecular Inc.)

November 21, 2016 (initial issuance)

January 6, 2017 (amended)

February 22, 2024 (amended)

Authorization (PDF, 84 KB)

Letter granting EUA amendment(s) (PDF, 150 KB)

Letter granting EUA amendment(s) (PDF, 160 KB)

FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 
Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)

December 9, 2016

October 5, 2021 (amended)

Authorization (PDF, 312 KB)FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 
Gene-RADAR Zika Virus Test (Nanobiosym Diagnostics, Inc.)March 20, 2017Authorization (PDF, 313 KB)FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) 
TaqPath Zika Virus Kit (Thermo Fisher Scientific)August 2, 2017Authorization (PDF, 292 KB)FR notice

Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

 
CII-ArboViroPlex rRT-PCR Assay (Columbia University)August 11, 2017Authorization (PDF, 377 KB)FR noticeEmergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

 

back to list of current EUAs

Related Links

Influenza Diagnostic Tests - In response to requests from the public, FDA is providing a list of in vitro diagnostic tests that have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA), for the detection of influenza in certain specimens from humans. Most tests listed on this page for the detection of seasonal influenza may be capable of detecting influenza A/H5N1, which is a subtype of influenza A. However, only tests specifically designed for subtyping will be able to determine if the person has seasonal flu, or influenza A/H5. (May 2024)

 

 

Back to Top