U.S. flag An official website of the United States government
  1. Home
  2. Emergency Preparedness and Response
  3. Counterterrorism and Emerging Threats
  4. Medical Countermeasures Initiative (MCMi)
  5. MCM Legal, Regulatory and Policy Framework
  6. Emergency Use Authorization--Archived Information
  1. Medical Countermeasures Initiative (MCMi)

Emergency Use Authorization--Archived Information

Emergency Use Authorization--Archived Information

View current EUAs

This page is intended to provide reference information on EUAs that were issued during previous public health emergencies (which have ended) and on amendments and revocations to EUAs.

All EUAs listed on this page are no longer in effect because they have been terminated.

Also see historical information about device EUAs, including links to archived fact sheets and letters of authorization. Some information may no longer be available. Please contact AskMCMi@fda.hhs.gov with questions.

Zika Virus EUA - ARCHIVED INFORMATION

View current EUA information related to Zika virus, including a list of in vitro diagnostics currently authorized for emergency use.

Medical Product Date of EUA Issuance Letter of Authorization or Other EUA-Related Information EUA Determination and Declaration

LightMix Zika rRT-PCR Test (Roche Molecular Systems, Inc.)

August 26, 2016 (initial issuance)

November 23, 2016 (amended)

March 13, 2017 (revoked)

In response to Roche Molecular Systems Inc.’s request dated March 10, 2017 to withdraw the LightMix Zika rRT-PCR Test due to technical performance and business considerations, on March 13, 2017 FDA revoked the EUA for emergency use of the LightMix Zika rRT-PCR Test.  As of March 13, 2017, the LightMix Zika rRT-PCR Test that was authorized by FDA for use by clinical laboratories for the qualitative detection of RNA from Zika virus is no longer authorized by FDA.

Historical information about Zika virus IVDs including letters of authorization, fact sheets, and labeling

Federal Register (FR) notices:

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

ZIKV Detect 2.0 IgM Capture ELISA (InBios International, Inc.)

August 17, 2016 (initial issuance)

March 27, 2017 (amended)

May 18, 2018 (amended)

May 23, 2019 (revoked)

FDA granted the De Novo classification request (PDF, 175 KB) for InBios International, Inc.’s (“InBios”) ZIKV Detect 2.0 IgM Capture ELISA, and established a new classification regulation for Zika virus serological reagents (class II) in 21 CFR 866.3935 on May 23, 2019. FDA has concluded that this is an adequate, approved, and available alternative for the InBios device, which was initially authorized for emergency use in 2016. Accordingly, on May 23, 2019, FDA determined that the criteria for issuance of an EUA under section 564(c) of the Act are no longer met and revoked the EUA for ZIKV Detect 2.0 IgM Capture ELISA, issued on August 17, 2016, and amended on March 27, 2017, and May 18, 2018, pursuant to section 564(g)(2) of the Act. Also see the FDA news release: FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

Historical information about Zika virus IVDs including letters of authorization, fact sheets, and labeling

Federal Register (FR) notices:

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

 

Ebola Virus EUA – ARCHIVED INFORMATION

View current EUA information related to Ebola, including EUAs noted below that have been reissued. Unless otherwise noted, Ebola EUAs in the list below have been reissued, and have current counterparts.

Medical Product Date of EUA Issuance Letter of Authorization or Other EUA-Related Information EUA Determination and Declaration

ReEBOV Antigen Rapid Test
(Zalgen Labs, LLC)

February 24, 2015 (initial issuance)

 

March 16, 2015 (reissuance)

 

November 3, 2016 (reissuance)

This EUA does not have a current counterpart.

On May 18, 2018, FDA revoked the EUA for emergency use of the ReEBOV Antigen Rapid Test, which was authorized by FDA for the presumptive detection of Zaire Ebola virus (detected in the West Africa outbreak in 2014), Sudan Ebola virus, and Bundibugyo Ebola virus in fingerstick (capillary) whole blood, venous whole blood, and plasma from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection). On February 24, 2015, based on a request by Corgenix Inc. (“Corgenix”), FDA issued a letter authorizing the emergency use of this test. On November 3, 2016, FDA reissued the EUA to allow Zalgen Labs, LLC (“Zalgen”) (and its authorized distributors) to distribute the ReEBOV Antigen Rapid Test manufactured by Corgenix , as well as distribute the ReEBOV Antigen Rapid Test manufactured by Zalgen if it met certain conditions, including that FDA concur after receiving performance characteristics for the Zalgen manufactured ReEBOV Antigen Rapid Test.  In a letter to FDA dated March 1, 2018, Zalgen requested to FDA that the transfer of the EUA from Corgenix be withdrawn. In addition, there is no remaining viable inventory of the ReEBOV Antigen Rapid Test manufactured by Corgenix. As a result, this product will no longer be made available. These circumstances make revocation of the EUA appropriate to protect the public health or safety.

Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Virus (Federal Register notice, August 2, 2018)

Historical information about Ebola virus IVDs including letters of authorization, fact sheets, and labeling

Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Virus (Federal Register notice, June 5, 2015)

 

 Declaration (still in effect)

In vitro diagnostics

Various

Historical information about Ebola virus IVDs 2014-2016 including letters of authorization, fact sheets, and labeling

FR notices:

 Declaration (still in effect)

back to list of archived EUAs

 

Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA – ARCHIVED INFORMATION

View current EUA information related to MERS-CoV. MERS-CoV EUAs in the list below have been reissued, and have current counterparts.

Medical Product Date of EUA Issuance Letter of Authorization or Other EUA-Related Information EUA Determination and Declaration PREP Act Declaration (if applicable)

CDC Novel Coronavirus 2012 Real-time RT-PCR Assay

June 5, 2013

(Note: This EUA was reissued in its entirety on June 10, 2014 – current EUA)

Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Middle East Respiratory Syndrome Coronavirus (FR notice, July 17, 2013 ) Determination and Declaration – HHS (still in effect)  (see Determination)

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

July 17, 2015 

(Note: This EUA was reissued in its entirety on  February 12, 2016 – current EUA)

Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Middle East Respiratory Syndrome Coronavirus (FR notice, September 1, 2015 ) Determination and Declaration – HHS (still in effect)  (see Determination)

back to list of archived EUAs

H1N1 EUAs - ARCHIVED INFORMATION

There are no current EUAs for H1N1.

Medical Product Date of EUA Issuance Letter of Authorization or Other EUA-Related Information EUA Determination and Declaration

Antiviral Disposition: Oseltamivir (Tamiflu), Zanamivir (Relenza), and Peramivir

June 22, 2010

Authorization Disposition Letter and Question and Answer Attachment (June 22, 2010 - ARCHIVED)

Tamiflu and Relenza Emergency Use Authorization Disposition Letters and Question and Answer Attachments (June 22, 2010 - ARCHIVED)

Declaration of Emergency Pursuant to Section 564 of the FD&C Act and Renewal of Determination that a Public Health Emergency Exists (March 26, 2010) (PDF, 151 KB - ARCHIVED)

Antivirals

 Various

Peramivir

Tamiflu

Relenza

(see above)

In vitro diagnostics

Various Historical information about 2009 H1N1 Influenza EUAs for IVDs including letters of authorization, fact sheets, and labeling (see above)

Personal Protective Equipment (PPE)

May 1, 2009  Historical information about 2009 H1N1 Influenza EUAs for PPE including letters of authorization and fact sheets (see above)

back to list of archived EUAs

Anthrax Vaccine Adsorbed (AVA) EUA - ARCHIVED INFORMATION

There are no current EUAs for Anthrax Vaccine Adsorbed (AVA); also see information about AVA approval. Note that current anthrax-related EUAs are in place for doxycycline mass dispensing and National Postal Model Anthrax EUA.

Medical Product Date of EUA Issuance Letter of Authorization or Other EUA-Related Information EUA Determination and Declaration  PREP Act Declaration (if applicable)

AVA

January 14, 2005

Extension (FR notice, August 3, 2005)

Termination (FR notice, February 1, 2006)

Determination and Declaration Regarding Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax (FR notice, February 2, 2005)

Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax (FR notice, February 2, 2005)

back to list of archived EUAs

Related Links