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  1. MCM Legal, Regulatory and Policy Framework

Emergency Use Authorization--Archived Information

View current EUAs

This page is intended to provide reference information on EUAs that were previously issued, and on amendments and revocations to EUAs. Skip to terminated EUAs

Anthrax: Doxycycline Mass Dispensing EUA Information

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, 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.

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)

Oral formulations of doxycycline products for the post-exposure prophylaxis (PEP) of inhalational anthrax (“Doxycycline mass dispensing EUA”)

July 21, 2011

2011 Letter of Authorization (PDF, 9.0 MB)

Authorization of Emergency Use of Oral Formulations of Doxycycline (August 4, 2011) 


 

Stakeholders should refer to the 2016 FDA Doxycycline Emergency Dispensing Order and CDC Doxycycline Emergency Use Instructions (EUI) for current anthrax preparedness information.

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 Regarding Emergency Use of All Oral Formulations of Doxycycline Accompanied by Emergency Use Information (July 20, 2012)

Renewal of Declaration on Emergency Use of Doxycycline (July 20, 2011)

Anthrax Medical Countermeasures-Amendment (The amendment of the October 1, 2008, declaration is effective as of January 1, 2016.)

 

Anthrax: National Postal Model Anthrax EUA Information

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) 

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)
 

Stakeholders should refer to the 2016 FDA Doxycycline Emergency Dispensing Order and CDC Doxycycline Emergency Use Instructions (EUI) for current anthrax preparedness information.

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 (The amendment of the October 1, 2008, declaration is effective as of January 1, 2016.)

 

 Terminated EUAs

The following EUAs 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)

xMAP MultiFLEX Zika RNA Assay (Luminex Corporation)

August 4, 2016 (initial issuance)

January 7, 2017 (amended)

May 19, 2017 (amended)

July 3, 2019 (revoked)

In a letter to FDA dated June 18, 2019, Luminex Corporation requested that the EUA for the xMAP MultiFLEX Zika RNA Assay issued on August 4, 2016, and amended on January 7, 2017, and May 19, 2017, be withdrawn. Luminex has decided to discontinue manufacture of the product and there is no remaining viable inventory of the xMAP MultiFLEX Zika RNA Assay. As a result, this product will no longer be marketed, and these circumstances make revocation appropriate to protect the public health or safety. Accordingly, on July 3, 2019, FDA revoked the EUA for xMAP MultiFLEX Zika RNA Assay, pursuant to section 564(g)(2) of the Act. As of July 3, 2019, the xMAP MultiFLEX Zika RNA Assay 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)

ADVIA Centaur Zika test (Siemens Healthcare Diagnostics Inc.)

September 18, 2017 (initial issuance)

November 16, 2017 (amended)

April 18, 2019 (amended)

July 17, 2019 (revoked)

Siemens Healthcare Diagnostics Inc.’s (“Siemens”) ADVIA Centaur Zika test (K191578) was determined to be substantially equivalent to a legally marketed Class II predicate device, classified under 21 CFR 866.3935, with the generic name “Zika virus serological reagents,” on July 17, 2019. FDA has concluded “that this is an adequate, approved, and available alternative for the Siemens device which was initially authorized for emergency use in 2017 for purposes of section 564(c)(3) of the Act.” In the context of section 564, the term “approved” refers to a product that is approved, licensed, or cleared under section 505, 510(k), or 515 of the FD&C Act or section 351 of the Public Health Service Act. See section 564(a)(2) of the FD&C Act. Accordingly, on July 17, 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 ADVIA Centaur Zika test, issued on September 18, 2017, and amended on November 16, 2017, and April 18, 2019, pursuant to section 564(g)(2) of the Act.

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

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)

ReEBOV Antigen Rapid Test
(Zalgen Labs, LLC)

February 24, 2015 (initial issuance)

 

March 16, 2015 (reissuance)

November 3, 2016 (reissuance)

May 18, 2019 (revoked)

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)

OraQuick Ebola Rapid Antigen Test - for use with whole blood (OraSure Technologies, Inc.)

and

OraQuick Ebola Rapid Antigen Test  - for use with cadaveric oral fluid (OraSure Technologies, Inc.)

Whole blood
July 31, 2015 (initial issuance)

January 30, 2019 (amended)

October 10, 2019 (revoked)

Cadaveric oral fluid
March 4, 2016 (initial issuance)

September 26, 2016 (reissuance)

February 1, 2019 (amended)

October 10, 2019 (revoked)

These EUAs do not have current counterparts because the De Novo request was granted, allowing the test to be marketed in the U.S.

FDA granted the De Novo classification request (PDF, 355 KB) for OraSure Technologies Inc.’s (“OraSure’s”) OraQuick Ebola Rapid Antigen Test, and established a new classification regulation for “Device to detect antigens of biothreat microbial agents in human clinical specimens” (class II) in 21 CFR 866.4002 on October 10, 2019. FDA has concluded that this is an adequate, approved, and available alternative for the OraSure devices which were initially authorized for emergency use in 2015, for use with whole blood specimens and 2016, for cadaveric oral fluid. Accordingly, on October 10, 2019, FDA determined that the criteria for issuance of both Emergency Use Authorizations (EUAs) under section 564(c) of the Federal Food, Drug and Cosmetic Act (the Act) are no longer met and revoked the EUAs for: (1) OraQuick Ebola Rapid Antigen Test for use with whole blood specimens issued on July 31, 2015, and amended on March 18, 2016, and January 30, 2019, and (2) OraQuick Ebola Rapid Antigen Test for use with cadaveric oral fluid issued on March 4, 2016, and amended on November 14, 2016, and February 1, 2019, pursuant to section 564(g)(2) of the Act. Also see the FDA news release: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens

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

Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability (Federal Register notice, April 22, 2016)

 

 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

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