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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All of the EUAs below have been terminated and this information is no longer current.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 EquipmentDate*Letter of
Authorization
Fact
Sheet
Disposable N95 Respirators from Strategic National Stockpile5/1/09[Authorization]
[Amendment]
[Fact Sheet]

In Vitro Diagnostics (IVD)

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

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 In a letter to FDA dated March 1, 2018, Zalgen requested to FDA that the transfer of the EUA from Corgenix be withdrawn.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 Test2/24/15[Authorization][Healthcare][Patients][Labeling]
RealStar® Ebolavirus RT-PCR Kit 1.011/10/14[Authorization][Healthcare][Patients][Labeling]
BioFire Defense LLC FilmArray NGDS BT-E Assay10/25/14[Authorization][Healthcare][Patients][Labeling]
CDC Ebola Virus NP Real-time RT-PCR Assay10/10/14[Authorization][Healthcare][Patients][Labeling]
CDC Ebola Virus VP40 Real-time RT-PCR Assay10/10/14[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 Assay5/4/10[Authorization][Healthcare][Patients][Labeling]
Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay3/23/10[Authorization][Healthcare][Patients][Labeling]
IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay from IntelligentMDx3/22/10[Authorization][Healthcare][Patients][Labeling]
Qiagen artus® Inf. A H1N1 2009 LC RT-PCR Kit3/11/10[Authorization][Healthcare][Patients][Labeling]
Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit2/16/10[Authorization][Healthcare][Patients][Labeling]
ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test2/1/10[Authorization][Healthcare][Patients][Labeling]
ViraCor 2009 H1N1 Influenza A Real-time RT-PCR1/21/10[Authorization][Healthcare][Patients][Labeling]
Cepheid Xpert® Flu A Panel for the Diagnosis of 2009 H1N1 Influenza Virus Infection12/24/09[Authorization][Healthcare][Patients][Labeling]
CDC rRT-PCR Swine Flu Panel on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Instrument12/18/09[Authorization][Healthcare][Patients][Labeling]
CDC Swine Influenza Virus Real-time RT-PCR Detection Panel12/18/09[Authorization][Healthcare][Patients][Labeling]
Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR12/18/09[Authorization][Healthcare][Patients][Labeling]
Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) Test12/18/09[Authorization][Healthcare][Patients][Labeling]
TessArray Resequencing Influenza A Microarray Detection Panel12/16/09[Authorization][Healthcare][Patients][Labeling]
GeneSTAT 2009 A/H1N1 Influenza Test12/9/09[Authorization][Healthcare][Patients][Labeling]
Roche RealTime ready Influenza A/H1N1 Test11/13/09[Authorization][Healthcare][Patients][Labeling]
Prodesse ProFlu-ST Influenza A assay for the diagnosis of 2009 H1N1 Influenza virus infection10/27/09[Authorization][Healthcare][Patients][Labeling]
Diatherix 2009 H1N1 Test10/9/09[Authorization][Healthcare][Patients][Labeling]
CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel with additional specimens and reagents5/2/09[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