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  1. Medical Device Safety

Historical Information about Device Emergency Use Authorizations

Historical Information about Device Emergency Use Authorizations

All of the EUAs below have been terminated and this information is no longer current.

Personal Protective Equipment (PPE)

Personal Protective Equipment Date* Letter of
Authorization
Fact
Sheet
Disposable N95 Respirators from Strategic National Stockpile 5/1/09 [Authorization]
[Amendment]
[Fact Sheet]

In Vitro Diagnostics (IVD)

Test Date** Letter of
Authorization
Fact
Sheet for
Healthcare
Providers
Fact
Sheet
for
Patients
Labeling
(PDF)

ADVIA Centaur Zika test (Siemens Healthcare Diagnostics Inc.)

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 emergency use authorization (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.

4/18/19 [Authorization]
[Amendment]
[Amendment]
[Healthcare] [Patients] [Labeling]

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

FDA granted the De Novo classification request 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 (https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180069.pdf).  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 emergency use authorization (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.

5/18/18 [Authorization]
[Amendment]
[Amendment]
[Healthcare] [Patients] [Labeling]

xMAP MultiFLEX Zika RNA Assay (Luminex Corporation)

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.

5/19/17 [Authorization] [Amendment] [Amendment] [Healthcare] [Patients] [Labeling]

ReEBOV Antigen Rapid Test (Zalgen Labs, LLC)

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.

11/3/16 [Authorization] [Healthcare] [Patients] [Labeling]

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

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.

8/26/16 [Authorization]
[Amendment]
[Healthcare] [Patients] [Labeling]
ReEBOV™ Antigen Rapid Test (Corgenix Inc.) 3/16/15 [Authorization] [Healthcare] [Patients] [Labeling]
ReEBOV™ Antigen Rapid Test 2/24/15 [Authorization] [Healthcare] [Patients] [Labeling]
RealStar® Ebolavirus RT-PCR Kit 1.0 11/10/14 [Authorization] [Healthcare] [Patients] [Labeling]
BioFire Defense LLC FilmArray NGDS BT-E Assay 10/25/14 [Authorization] [Healthcare] [Patients] [Labeling]
CDC Ebola Virus NP Real-time RT-PCR Assay 10/10/14 [Authorization] [Healthcare] [Patients] [Labeling]
CDC Ebola Virus VP40 Real-time RT-PCR Assay 10/10/14 [Authorization] [Healthcare] [Patients] [Labeling]
DoD EZ1 Real-time RT-PCR Assay (Ebola) 8/5/14 [Authorization] [Healthcare] [Patients] [Labeling]
IQuum Liat™ Influenza A/2009 H1N1 Assay 5/4/10 [Authorization] [Healthcare] [Patients] [Labeling]
Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay 3/23/10 [Authorization] [Healthcare] [Patients] [Labeling]
IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay from IntelligentMDx 3/22/10 [Authorization] [Healthcare] [Patients] [Labeling]
Qiagen artus® Inf. A H1N1 2009 LC RT-PCR Kit 3/11/10 [Authorization] [Healthcare] [Patients] [Labeling]
Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit 2/16/10 [Authorization] [Healthcare] [Patients] [Labeling]
ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test 2/1/10 [Authorization] [Healthcare] [Patients] [Labeling]
ViraCor 2009 H1N1 Influenza A Real-time RT-PCR 1/21/10 [Authorization] [Healthcare] [Patients] [Labeling]
Cepheid Xpert® Flu A Panel for the Diagnosis of 2009 H1N1 Influenza Virus Infection 12/24/09 [Authorization] [Healthcare] [Patients] [Labeling]
CDC rRT-PCR Swine Flu Panel on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Instrument 12/18/09 [Authorization] [Healthcare] [Patients] [Labeling]
CDC Swine Influenza Virus Real-time RT-PCR Detection Panel 12/18/09 [Authorization] [Healthcare] [Patients] [Labeling]
Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR 12/18/09 [Authorization] [Healthcare] [Patients] [Labeling]
Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) Test 12/18/09 [Authorization] [Healthcare] [Patients] [Labeling]
TessArray Resequencing Influenza A Microarray Detection Panel 12/16/09 [Authorization] [Healthcare] [Patients] [Labeling]
GeneSTAT 2009 A/H1N1 Influenza Test 12/9/09 [Authorization] [Healthcare] [Patients] [Labeling]
Roche RealTime ready Influenza A/H1N1 Test 11/13/09 [Authorization] [Healthcare] [Patients] [Labeling]
Prodesse ProFlu-ST Influenza A assay for the diagnosis of 2009 H1N1 Influenza virus infection 10/27/09 [Authorization] [Healthcare] [Patients] [Labeling]
Diatherix 2009 H1N1 Test 10/9/09 [Authorization] [Healthcare] [Patients] [Labeling]
CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel with additional specimens and reagents 5/2/09 [Authorization] [Healthcare] [Patients] [Labeling]

*Note that Secretary’s determination and declaration were issued based on revised authorities under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).

** Date of Authorization or of Latest Amendment