Emergency Use Authorization
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 EUA 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. HHS EUA Declarations, and associated determinations, supporting use of EUAs are described below. Please note that an HHS EUA Declaration is distinct from, and not dependent on, a Public Health Emergency (PHE) Declaration under section 319 of the PHS Act.
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) to allow HHS to issue a declaration to provide immunity (except for willful misconduct) for activities related to administration or use of ‘covered countermeasures,’ defined to include medical products authorized for emergency use. This PREP Act Declaration is distinct from, and not dependent on, HHS EUA Declarations or section 319 PHE Declarations.
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.
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.
New World Screwworm (NWS)
Effective August 18, 2025, pursuant to section 564 of the FD&C Act, the HHS Secretary:
- Determined that there is a significant potential for 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 New World Screwworm (Cochliomyia hominivorax); and
- declared that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent New World Screwworm myiasis in animals subject to the terms of any authorization issued under that section.
These actions permit FDA to issue EUAs for animal drugs for the treatment or prevention of NWS myiasis in animals. Upon issuance, information for each EUA will be added to the website here: New World Screwworm: Information for Veterinarians | FDA
Additional information:
- Animal Drugs for New World Screwworm | FDA
- Determination of a Significant Potential for a Public Health Emergency and Declaration that Circumstances Exist Justifying an Authorization Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)
Coronavirus Disease 2019 (COVID-19) EUA Information
- Coronavirus Disease (COVID-19) updates from FDA
- The HHS Secretary issued 4 COVID-19 EUA Declarations:
- EUA Declaration (effective February 4, 2020) that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19
- EUA Declaration (effective March 2, 2020) that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak
- EUA Declaration (effective March 24, 2020) that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak
- EUA Declaration (effective March 27, 2020) for drugs and biologic products during the COVID-19 pandemic
- The HHS COVID-19 EUA Declarations were based on an HHS COVID-19 Determination:
- Determination of a Public Health Emergency Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (February 4, 2020)
- Amended Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the FD&C Act (effective March 15, 2023; Federal Register notice March 20, 2023
- EUAs for Drugs and Non-Vaccine Biological Products
- Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products including letters of authorization, fact sheets, Dear Health Care Provider letters, and additional information about COVID-19 therapeutics.
- CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19
- Revocation notices for COVID-19 drug and biological product EUAs are available at: Emergency Use Authorization--Archived Information.
- Related links:
- View the FDA’s COVID-19 Drugs page to see all products approved to treat COVID-19 without any remaining EUA authorized uses.
- Expiration Dating Extension – COVID-19 Therapeutics
- COVID-19 EUAs for 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.
- Blood Purification Devices EUAs
- Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
- In Vitro Diagnostics EUAs
- Infusion Pump EUAs
- Personal Protective Equipment EUAs
- Remote or Wearable Patient Monitoring Devices EUAs
- Respiratory Assist Devices EUAs
- Ventilators and Ventilator Accessories EUAs
- Other Medical Device EUAs
- Medical Device Federal Register Notices
- Revocation notices for COVID-19 device EUAs are available at: Historical Information about Device Emergency Use Authorizations
- Related links:
- SARS-CoV-2 Diagnostic Tests for COVID-19 that have been granted a De Novo, 510(k) clearance or PMA
- Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) and Decontamination and Bioburden Reduction Systems
- Related links:
- Transition guidance for COVID-19 device EUAs
- March 24, 2023 - The FDA finalized two guidances
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices (April 18, 2023)
- March 24, 2023 - The FDA finalized two guidances
- Archived information for revoked COVID-19 Vaccine and Convalescent Plasma EUAs
- Emergency Use Authorization--Archived Information (information about terminated or revoked EUAs)
- COVID-19 CBER-Regulated Biologics
- Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma
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 Issuance | Letter of Authorization (PDF) | Authorized Use | Fact 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) |
| 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:
- Policy for Monkeypox Tests to Address the Public Health Emergency
- Monkeypox Emergency Use Authorizations for Medical Devices (including EUA templates)
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).
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.
Other Current EUAs
The tables below provide information on current EUAs:
- Anthrax EUAs
- Ebola Virus EUA Information
- Freeze Dried Plasma Information
- H7N9 Influenza EUA Information
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
- Nerve Agent EUA Information
- Zika Virus EUA Information
Information about EUAs that are no longer in effect is available on our EUA archive 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.
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 Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA 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 notice |
| Declaration 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) | FR notice |
| Declaration 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) | FR notice |
| Declaration 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) | FR notice |
| Declaration 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 notice |
| Declaration 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, 2014 | Authorization (PDF, 2.2 MB) | FR notice |
| Declaration 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 notice |
| Declaration 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 notice |
| Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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 Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
| octaplas LGPowder (Octapharma Pharmazeutika Produktionsges.m.b.H.) | August 8, 2024 (issuance) June 12, 2025 (amendment) | Authorization (PDF, 540KB) Letter granting EUA amendments (PDF, 148 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) | |
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) |
On July 18, 2024, the Secretary amended the April 19, 2013, determination made pursuant to the FD&C Act, regarding the avian influenza A (H79N) virus, and determined pursuant to his authority under the Act that there is a significant potential for 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 biological agents, namely pandemic influenza A viruses and influenza A viruses with pandemic potential.
Broadening the previous determination to apply to pandemic influenza A viruses and influenza A viruses with pandemic potential—rather than just H7N9 specifically—appropriately covers the range of known and emerging influenza A viruses that present a significant potential for a public health emergency. The amended determination continues to support the existing 2013 EUA declaration and subsequent EUAs for H7N9 IVDs.
For more information about the diagnostics below, also see Emergency Use Authorizations for Medical Devices: 2013 H7N9 Influenza Emergency Use Authorization (Potential Emergency).
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheet and Manufacturer Instructions/Package Insert | EUA 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) | 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 Assay | February 14, 2014 | Authorization (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) | 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 Test | April 25, 2014 | Authorization | FR notice | Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) | 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.) |
For more information about the diagnostics below, also see Emergency Use Authorizations for Medical Devices: 2013 Coronavirus Emergency Use Authorization (Potential Emergency).
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA 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 notice |
| Determination 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 February 12, 2016 (reissuance)
| Authorization (PDF, 238 KB) | FR notice |
| Determination and Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) (May 29, 2013) |
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 Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA 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) |
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 Product | Date of EUA Issuance | Letters | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA 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 notice |
| Emergency 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 notice |
| Emergency 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 notice |
| Emergency 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 notice |
| Emergency 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 notice |
| Emergency 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 notice |
| Emergency 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 notice |
| Emergency 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, 2016 | Authorization (PDF, 355 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) | |
| Zika Virus Detection by RT-PCR Test (ARUP Laboratories) | September 28, 2016 October 5, 2021 (amended) | Authorization (PDF, 98 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) | |
| 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 notice |
| Emergency 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 notice |
| Emergency 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, 2017 | Authorization (PDF, 313 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) | |
| TaqPath Zika Virus Kit (Thermo Fisher Scientific) | August 2, 2017 | Authorization (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, 2017 | Authorization (PDF, 377 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) |
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Related Links
- Coronavirus Disease 2019 (COVID-19)
- Summary of Process for EUA Issuance
- Current Emergency Use Authorizations for Medical Devices
- FAQs: What happens to EUAs when a public health emergency ends?
- How to Submit a Pre-EUA for In vitro Diagnostics (IVDs) to FDA (for test manufacturers)
- Information for Laboratories Implementing IVD Tests Under EUA
- Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019 (June 2, 2020)
- Emergency Use Authorization--Archived Information
- Emergency Dispensing Orders
- 21st Century Cures Act: MCM-Related Cures Provisions
- Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
- Public Readiness and Emergency Preparedness (PREP) Act
- HHS Public Health Emergency EUA Authorization Declarations
- Ebola Preparedness and Response Updates from FDA
- Zika Virus Response Updates from FDA
- Historical Information about Device Emergency Use Authorizations