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  1. MCM Legal, Regulatory and Policy Framework

Emergency Use Authorization

Emergency Use Authorization (EUA) information, and list of all current EUAs

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The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies. 

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow 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 there are no adequate, approved, and available alternatives.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.

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)

Questions & Answers

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.  

Emergency Diagnostics Information

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Information about EUAs that are no longer in effect is available on our EUA archive page.

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Anthrax EUAs

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.

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Ebola Virus EUA Information

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

For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).

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)

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

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

 FR notice

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

 

FilmArray NGDS BT-E Assay 
(Biofire Defense, LLC)

October 25, 2014 (initial issuance) 

March 2, 2015 (reissuance)

 

Authorization (PDF, 326 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  

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

Authorization (PDF,  240 KB)

 FR notice

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

 

Idylla Ebola Virus Triage Test (Biocartis NV)

May 26, 2016

Authorization  (PDF,  321 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)

 

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Enterovirus D68 (EV-D68) EUA Information

For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).

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 Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR)

May 12, 2015

Authorization (PDF, 229 KB)

 FR notice

Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 (February 6, 2015)

 

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Freeze Dried Plasma Information

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)

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

 

July 9, 2018

Authorization (PDF,  203 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)

 

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H7N9 Influenza EUA Information

For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).

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)

Additional information from HHS

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)

Additional information from HHS

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)

Additional information from HHS

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.)

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Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information

For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).

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)

 

 

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)

Additional information from HHS

 

RealStar MERS-CoV RT-PCR Kit U.S.

July 17, 2015
(initial issuance)

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)

Additional information from HHS

 

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Nerve Agent EUA Information

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)

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Zika Virus EUA Information

Zika virus response updates from FDA

Zika virus diagnostic development information

For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).

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.
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

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)

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

March 17, 2016 (initial issuance)

September 21, 2016 (amended)

January 12, 2017 (amended)

February 28, 2017 (amended)

April 6, 2017 (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)

 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)

 

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)

 

 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)

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

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)

Authorization (PDF, 84 KB)

Letter granting EUA amendment(s) (PDF, 150 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

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)

 

LIAISON XL Zika Capture IgM Assay II (DiaSorin Incorporated)

April 5, 2017 (initial issuance)

November 6, 2017 (amended)

December 27, 2018 (amended)

Authorization (PDF, 363 KB)

Letter granting EUA amendment(s) (PDF, 45 KB)

Letter granting EUA amendment(s) (PDF, 66 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)

 

 


DPP Zika IgM Assay System (Chembio Diagnostic Systems, Inc.)

September 27, 2017 (initial issuance)

February 6, 2018 (amended)

August 3, 2018 (amended)

Authorization (PDF, 424 KB)

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

Letter granting EUA amendment(s) (PDF, 129  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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