Emergency Preparedness and Response

Emergency Use Authorization

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Emergency Use Authorization, with Emergency sign

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 the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which was enacted in March 2013

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.  

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Information about EUAs that are no longer in effect is available on our EUA archive page.

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On December 9, 2015, the HHS Secretary amended seven Public Readiness and Emergency Preparedness (PREP) Act declarations, continuing PREP Act coverage for pandemic influenza, Ebola virus disease vaccines and therapeutics, anthrax, botulinum toxin, smallpox, and Acute Radiation Syndrome medical countermeasures. On December 12, 2016, the HHS Secretary amended two PREP Act declarations, continuing PREP Act coverage for Ebola virus disease vaccines and therapeuticsAlso see PREP Act FAQs.

Anthrax: Doxycycline Mass Dispensing EUA Information*

*Note: Based on the April 13, 2016, issuance of the Doxycycline Emergency Dispensing Order and Doxycycline Emergency Use Instructions (EUI), which replace the need for an EUA for doxycycline mass dispensing, this EUA will be terminated by FDA. Notice of such termination will be published in the Federal Register.

 More: current drug information related to anthrax, from the Center for Drug Evaluation and Research

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Anthrax: National Postal Model Anthrax EUA Information

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUA Fact Sheets and LabelingEUA Determination and Declaration (Effective Date)PREP Act Declaration (if applicable) 

Oral formulations of doxycycline products for the post-exposure prophylaxis (PEP) of inhalational anthrax

October 14, 2011

 

(originally issued on October 6, 2008, with subsequent amendments)

Amendment to the Letter of Authorization (October 14, 2011) (PDF, 7 MB)


Amendment to the Letter of Authorization (August 23, 2010) (PDF, 2 MB)

 

Amendment to the Letter of Authorization (February 25, 2009) (PDF, 97 KB)
 

Amended EUA for doxycycline hyclate tablet for USPS as part of the National Postal Model (November 28, 2011)

 

EUA for Pre-event Provision of Potential Use of Doxycycline for Inhalation Anthrax (October 21, 2008)
 

Interim Questions and Answers: Emergency Use Authorization for Oral Formulations of Doxycycline for Post-Exposure Prophylaxis of Inhalational Anthrax

Declaration That Circumstances Exist Justifying Authorization of Emergency Use of All Oral Formulations of Doxycycline Accompanied by Emergency Use Information (June 27, 2013)

Renewal of Declaration ... (July 20, 2012)

Renewal of Declaration ... (July 20, 2011)

Renewal of Declaration ... (October 1, 2010)

Renewal of Declaration ... (October 1, 2009)

Determination and Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information – Federal Register (October 1, 2008)

Anthrax Medical Countermeasures-Amendment (December 9, 2015)

 

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Ebola Virus EUA Information

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and Labeling 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 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)

 

Authorization (PDF, 282 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)

 

Authorization (PDF, 285 KB) FR noticeDeclaration 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 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  

Authorization (PDF,  73 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, 2014

Authorization (PDF,  2.2 MB) FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) 
ReEBOV™ Antigen Rapid Test 
(Zalgen Labs, LLC)

February 24, 2015 (initial issuance)

March 16, 2015 (reissuance)

November 3, 2016 (reissuance)

 

Authorization (PDF,  54 KB) FR noticeDeclaration 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 noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) 
OraQuick® Ebola Rapid Antigen Test - for use with whole blood
(OraSure Technologies, Inc.)

July 31, 2015

Authorization (PDF,  250 KB) FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) 
OraQuick® Ebola Rapid Antigen Test  - for use with cadaveric oral fluid
(OraSure Technologies, Inc.)

March 4, 2016 (initial issuance)

September 26, 2016 (reissuance)

 

 

Authorization (PDF,  266 KB) FR noticeDeclaration 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 noticeDeclaration 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

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and Labeling 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 noticeDetermination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 (February 6, 2015) 

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H7N9 Influenza EUA Information

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

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and LabelingEUA 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

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and LabelingEUA Determination and Declaration (Effective Date)PREP Act Declaration (if applicable)
2 mg Atropine Auto-Injector (Rafa Laboratories Ltd.)

April 11, 2017 (initial issuance)

Amended May 23, 2017

Letter of Authorization (PDF,  514 KB)

Letter granting EUA amendment(s) (PDF, 28 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

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.
Medical ProductDate of EUA IssuanceLettersFederal Register Notice for EUA

Fact Sheets and Labeling 

EUA Determination and Declaration (Effective Date)PREP Act Declaration (if applicable)

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

(Zika MAC-ELISA)

CDC statement on this EUA

February 26, 2016 (initial issuance)

Amended June 29, 2016 

Amended November 15, 2016

Amended December 6, 2016

Amended May 3, 2017

Amended July 31, 2017

Authorization (PDF, 494 KB)

Letter granting EUA amendment(s) (PDF, 532KB)

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

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

Letter granting EUA amendment(s) (PDF, 112KB)

 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)

Amended September 21, 2016

Amended January 12, 2017

Amended March 1, 2017

Amended April 6, 2017 

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)

Amended October 7, 2016

Amended April 11, 2017

Authorization (PDF, 339 KB)

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

Amended October 31, 2016

Amended March 6, 2017

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)

Amended September 7, 2016

Amended April 12, 2017

 

Authorization (PDF, 305 KB)

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

Zika Virus Real-time RT-PCR Test (Viracor Eurofins)

July 19, 2016 (initial issuance)

Amended February 28, 2017

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)

Amended December 19, 2016

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) 

xMAP® MultiFLEX™ Zika RNA Assay (Luminex Corporation)

August 4, 2016 (initial issuance)

Amended January 7, 2017

Amended May 19, 2017

 

Authorization (PDF,  505 KB)

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

ZIKV Detect™ IgM Capture ELISA (InBios International, Inc.)

August 17, 2016 (initial issuance)

Amended March 27, 2017

Authorization (PDF,  528 KB)

Letter granting EUA amendment(s) (PDF, 125 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 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)

Amended January 6, 2017

Authorization (PDF, 84 KB)

Letter granting EUA amendment(s) (PDF, 150 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, 2016Authorization (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) 
LIAISON® XL Zika Capture IgM Assay (DiaSorin Incorporated)April 5, 2017Authorization (PDF, 363 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) 

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, 376 KB) 

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

 

 

 

 

ADVIA Centaur Zika test (Siemens Healthcare Diagnostics Inc.)

September 18, 2017Authorization (PDF, 74.3 KB) 

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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