Emergency Preparedness and Response

Emergency Use Authorization--Archived Information

This page is intended to provide reference information on EUAs that were issued during previous public health emergencies (which have ended) and on amendments to EUAs.  Learn more about EUAs and view a list of current EUAs on our main EUA page.

All EUAs listed on this page are NO LONGER IN EFFECT because they have been terminated.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 ProductDate of EUA IssuanceLetter of Authorization or Other EUA-Related InformationEUA Determination and Declaration

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

August 26, 2016

Amended November 23, 2016

Revoked March 13, 2017

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) notice:

 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. Ebola EUAs in the list below have been reissued, and have current counterparts.

Medical ProductDate of EUA IssuanceLetter of Authorization or Other EUA-Related InformationEUA Determination and Declaration
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 ProductDate of EUA IssuanceLetter of Authorization or Other EUA-Related InformationEUA Determination and DeclarationPREP 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 ProductDate of EUA IssuanceLetter of Authorization or Other EUA-Related InformationEUA Determination and Declaration
Antiviral Disposition: Oseltamivir (Tamiflu), Zanamivir (Relenza), and PeramivirJune 22, 2010

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

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

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)
Antivirals Various

Peramivir

Tamiflu

Relenza

(see above)

In vitro diagnostics

VariousHistorical 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 ProductDate of EUA IssuanceLetter of Authorization or Other EUA-Related InformationEUA Determination and Declaration PREP Act Declaration (if applicable)
AVAJanuary 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

 

Page Last Updated: 04/06/2017
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