Medical Devices

Emergency Use Authorizations

This page lists current and terminated Emergency Use Authorizations that make available diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies.


Zika Virus Emergency Use Authorization

On February 26, 2016, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of Health and Human Services (HHS), Sylvia Burwell, determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves Zika virus. Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb-3(b)(1)), and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under 21 U.S.C. § 360bbb-3(a).

On April 28, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Focus Diagnostics, Inc.'s, Zika Virus RNA Qualitative Real-Time RT-PCR test for the qualitative detection of RNA from Zika virus in human serum specimens from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by qualified laboratories designated by Focus Diagnostics, Inc., and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform high complexity tests.

On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention's (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside a patient-matched serum specimen from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., recent history of travel to geographic regions during a period of active Zika virus transmissions at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated as part of a public health response), by qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3). Where there are positive or equivocal results from the Zika MAC-ELISA, confirmation of the presence of anti-Zika IgM antibodies requires additional testing by CDC, or by authorized laboratories in consultation with CDC, using the CDC-issued algorithm.

On March 17, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, and chikungunya virus in human sera or cerebrospinal fluid (collected alongside a patient-matched serum specimen), and for the qualitative detection of Zika virus RNA in urine and amniotic fluid (each collected alongside a patient-matched serum specimen). The assay is intended for use with specimens collected from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated as part of a public health investigation). Testing is performed by qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3).

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2015 Enterovirus D68 (EV-D68) Emergency Use Authorization

On February 6, 2015, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of Health and Human Services (HHS), Sylvia Burwell, determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves EV-D68. Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb-3(b)(1)), and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for the detection of EV-D68, subject to the terms of any authorization issued under 21 U.S.C. § 360bbb-3(a).

On May 12, 2015, the FDA issued an Emergency Use Authorization (EUA) for the Centers for Disease Control and Prevention (CDC) Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR) for the in vitro qualitative detection of RNA from the Enterovirus D68 (EV-D68) strains detected in North America in 2014 in upper respiratory specimens (such as nasopharyngeal (NP) swabs, oropharyngeal (OP) swabs, dual NP/OP swabs, and/or nasal washes) and sera in conjunction with patient-matched upper respiratory specimen(s) from individuals with signs and symptoms of EV-D68 infection and/or epidemiologic risk factors, by qualified laboratories designated by CDC on specified instruments. This device will be distributed by CDC to qualified laboratories designated by CDC.

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2014 Ebola Virus Emergency Use Authorizations

On September 22, 2006, then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, determined, pursuant to section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. § 247d-6b), that the Ebola virus presents a material threat against the United States population sufficient to affect national security. Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb-3(b)(1)), and on the basis of such determination, the Secretary of HHS declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus, subject to the terms of any authorization issued under 21 U.S.C. § 360bbb-3(a).

On August 5, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the U.S. Department of Defense (DoD) EZ1 Real-time RT-PCR Assay for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in Trizol-inactivated whole blood or Trizol-inactivated plasma specimens from individuals in affected areas with signs and symptoms of Ebola virus infection or who are at risk for exposure or may have been exposed to the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in conjunction with epidemiological risk factors. This authorization is limited to the use of the authorized EZ1 rRT-PCR Assay on specified instruments by laboratories designated by DoD. In response to DoD’s request to amend this EUA, on October 10, 2014 FDA reissued the August 5, 2014, EUA in its entirety with the DoD-requested amendments incorporated. The amendments authorize the use of the DoD EZ1 rRT-PCR Assay in whole blood or plasma specimens, in addition to Trizol-inactivated whole blood or Trizol-inactivated plasma specimens, from individuals in affected areas with signs and symptoms of Ebola virus infection or who are at risk for exposure or may have been exposed to the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in conjunction with epidemiological risk factors, by laboratories designated by DoD. The amendments also include revisions to the Instructions for Use, product insert, and Fact Sheets for Health Care Providers and Patients to address the addition of whole blood and plasma specimens.

On October 10, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Centers for Disease Control and Prevention (CDC) Ebola Virus NP Real-time RT-PCR Assay for the in vitro qualitative detection of Ebola Zaire virus in whole blood, serum, and plasma specimens from individuals in affected areas with signs and symptoms of Ebola virus infection and/or epidemiological risk factors. The CDC Ebola Virus NP Real-time RT-PCR Assay can also be used with urine specimens when tested in conjunction with a patient-matched whole blood, serum, or plasma specimen. This authorization was limited to the use of the authorized CDC Ebola Virus NP Real-time RT-PCR Assay on the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument by qualified laboratories designated by CDC. In response to CDC's request to amend this EUA, on March 2, 2015, FDA reissued the October 10, 2014, EUA in its entirety with the CDC requested amendment incorporated. The amendments authorize use of the CDC Ebola Virus NP Real-time RT-PCR Assay with the BioRad CFX96 Touch Real-Time PCR instrument, in addition to the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument. The Instructions for Use and Fact Sheet for Health Care Providers have also been updated to incorporate this amendment. The amendments also allow the future use of "other authorized instruments", of "other extraction methods" and of "other authorized specimen types" when requested by CDC and concurred with by FDA.

On October 10, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Centers for Disease Control and Prevention (CDC) Ebola Virus VP40 Real-time RT-PCR Assay for the in vitro qualitative detection of Ebola Zaire virus in whole blood, serum, and plasma specimens from individuals in affected areas with signs and symptoms of Ebola virus infection and/or epidemiological risk factors. The CDC Ebola Virus VP40 Real-time RT-PCR Assay can also be used with urine specimens when tested in conjunction with a patient-matched whole blood, serum, or plasma specimen. This authorization was limited to the use of the authorized CDC Ebola Virus VP40 Real-time RT-PCR Assay on the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument by qualified laboratories designated by CDC. In response to CDC's request to amend this EUA, on March 2, 2015, FDA reissued the October 10, 2014, EUA in its entirety with the CDC requested amendment incorporated. The amendments authorize use of the CDC Ebola Virus VP40 Real-time RT-PCR Assay with the BioRad CFX96 Touch Real-Time PCR instrument, in addition to the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument. The Instructions for Use and Fact Sheet for Health Care Providers have also been updated to incorporate this amendment. The amendments also allow the future use of "other authorized instruments", of "other extraction methods" and "other authorized specimen types" when requested by CDC and concurred with by FDA.

On October 25, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the BioFire Defense LLC FilmArray Biothreat-E test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors.  The FilmArray Biothreat-E test can also be used with urine specimens when tested in conjunction with a patient-matched whole blood specimen. This authorization is limited to the use of the authorized FilmArray Biothreat-E test on only the FilmArray Instrument by CLIA Moderate and High Complexity Laboratories.

On October 25, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the BioFire Defense, LLC's FilmArray NGDS BT-E Assay for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in whole blood specimens from individuals with signs and symptoms of Ebola virus infection or who are at risk for exposure or may have been exposed to the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in conjunction with epidemiological risk factors. This authorization is limited to the use of the authorized FilmArray NGDS BT-E Assay on only the FilmArray Instrument by laboratories designated by the United States Department of Defense (DoD). In response to BioFire Defense, LLC's request to amend this EUA, on March 2, 2015, FDA reissued the October 25, 2014, EUA in its entirety with the BioFire Defense, LLC requested amendment incorporated. The amendments authorize use of plasma and serum specimens with the FilmArray NGDS BT-E Assay in addition to whole blood. The Instructions for Use and Fact Sheet for Health Care Providers have also been updated to incorporate this amendment. The amendments also allow the future use of "other specimen types" when requested by BioFire Defense, LLC and concurred with by FDA.

On November 10, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0 for the presumptive detection of RNA from Ebolaviruses [such as Zaire ebolavirus (including the Zaire ebolavirus strain detected in the West Africa outbreak 2014), Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus, and Reston ebolavirus] in EDTA plasma from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. This authorization is limited to the use of the authorized RealStar® Ebolavirus RT-PCR Kit 1.0 on only specified instruments by CLIA high complexity laboratories. The RealStar® Ebolavirus RT-PCR Kit 1.0 does not distinguish between the different Ebola virus species or strains. In response to altona Diagnostics GmbH’s request to amend this EUA, on November 26, 2014 FDA reissued the November 10, 2014, EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. The amendments allow, in addition to altona Diagnostics GmbH, distributors that are authorized by altona Diagnostics GmbH to distribute the RealStar® Ebolavirus RT-PCR Kit 1.0 with certain conditions applicable to such authorized distributor(s). Because this assay may be distributed outside the U.S., the amendments also allow the use of this assay under this EUA, with certain conditions, at non-U.S. laboratories that are similarly qualified as CLIA High Complexity Laboratories. The Instructions for Use and Fact Sheet for Health Care Providers have also been updated to incorporate these amendments.

On December 23, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize use of the LightMix® Ebola Zaire rRT-PCR Test for the presumptive detection of the Ebola Zaire virus in a preparation of whole blood from individuals with signs and symptoms of Ebola disease. The Test runs on only specified instruments by CLIA high complexity laboratories or similarly qualified non-U.S. laboratories.

On February 24, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the ReEBOV™ Antigen Rapid Test 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). The authorized ReEBOV™ Antigen Rapid Test is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. The authorized ReEBOV™ Antigen Rapid Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing. The ReEBOV™ Antigen Rapid Test is authorized for use in laboratories or facilities adequately equipped, trained, and capable of such testing (including treatment centers and public health clinics). The ReEBOV™ Antigen Rapid Test does not distinguish between the different Ebola virus strains. In response to Corgenix Inc.'s request to amend this EUA, on March 16, 2015 FDA reissued the February 24, 2015 EUA in its entirety with the Corgenix Inc. requested amendments incorporated. The amendments allow, in addition to Corgenix Inc., distributors that are authorized by Corgenix Inc. to distribute the ReEBOV™ Antigen Rapid Test with certain conditions applicable to such authorized distributor(s). The Instructions for Use have also been updated to incorporate these amendments.

On March 23, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Xpert® Ebola Assay for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the GeneXpert Instrument Systems in EDTA venous whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. The Xpert® Ebola Assay should be performed in CLIA Moderate and High Complexity Laboratories or in similarly qualified non-U.S. laboratories, by clinical laboratory personnel who have received specific training on the use of the Xpert® Ebola Assay on GeneXpert Instrument Systems.

OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.) - For Use with whole Blood - July 31, 2015

On July 31, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in venipuncture whole blood or fingerstick whole blood specimens 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), by laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics). The test may also detect antigens from Sudan Ebola virus and Bundibugyo Ebola virus; however, it does not distinguish between these different Ebola virus species. The OraQuick® Ebola Rapid Antigen Test is intended for circumstances when the use of a rapid Ebola virus test is determined to be more appropriate than the use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. The OraQuick® Ebola Rapid Antigen Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing of individuals without signs and symptoms of Ebola infection.

OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.) - For Use with Cadaveric Oral Fluid - March 4, 2016

On March 4, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in cadaveric oral fluid swab specimens from individuals with epidemiological risk factors for Ebola virus infection and suspected to have died of Ebola. The test is intended to aid in diagnosing Ebola Zaire virus infection as the cause of death in order to inform decisions on safe and dignified burial procedures to prevent transmission of Ebola virus in the community. The OraQuick® Ebola Rapid Antigen Test for use with cadaveric oral fluid is not intended for use with oral fluid specimens from living individuals.

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2013 Coronavirus Emergency Use Authorization (Potential Emergency)

On May 29, 2013 Secretary Kathleen Sebelius determined that Middle East respiratory syndrome coronavirus (MERS-CoV) poses a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. On the basis of this determination the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the Middle East respiratory syndrome coronavirus (MERS-CoV).
 

On June 5, 2013, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay for the presumptive detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in patients with signs and symptoms of MERS-CoV infection in conjunction with clinical and epidemiological risk factors by qualified laboratories.  In response to CDC’s request to amend this EUA, on June 10, 2014 FDA reissued the June 5, 2013, EUA in its entirety with the CDC-requested amendments incorporated.  The amendments authorize the expanded use of the CDC assay to include testing persons who may not be exhibiting signs and symptoms associated with MERS-CoV infection, but who meet certain epidemiological risk factors (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated as part of a public health investigation). The EUA amendments also include a new fact sheet for contacts of MERS cases and revisions/updates to the instructions for use and fact sheets for patients and health care professionals.  This device will be distributed by CDC to qualified laboratories.

On July 17, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the RealStar® MERS-CoV RT-PCR Kit U.S. for the in vitro qualitative detection of RNA from the Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012, in lower respiratory specimens (tracheal aspirate/tracheal secretions) from individuals with signs and symptoms of infection with MERS-CoV in conjunction with epidemiological risk factors for the presumptive detection of MERS-CoV, by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and similarly qualified non-U.S. laboratories. In response to altona Diagnostics GmbH's request to amend this EUA, on February 12, 2016 FDA reissued the July 17, 2015 EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. The amendments authorize the expanded use of the RealStar® MERS-CoV RT-PCR Kit U.S. to include the in vitro qualitative detection of genomic RNA from MERS-CoV in nasopharyngeal swabs from asymptomatic individuals suspected of exposure to MERS-CoV based on epidemiological risk factors (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-Co V cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated). The amendments also include a new Fact Sheet for Asymptomatic Individuals Suspected of Exposure to MERS-CoV Cases and revisions to the Instructions for Use, and Fact Sheets for Health Care Providers and Patients.

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2013 H7N9 Influenza Emergency Use Authorization (Potential Emergency)

On April 19, 2013 Secretary Kathleen Sebelius determined that avian influenza A(H7N9) poses a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. On the basis of this determination the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A(H7N9) virus.

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).
 

On April 22, 2013, the FDA issued an Emergency Use Authorization (EUA) for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. This test is for the presumptive detection of novel influenza A (H7N9) virus in conjunction with the FDA cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays in patients with signs and symptoms of respiratory infection. This device will be distributed by CDC to the public health and other qualified laboratories.

On February 14, 2014, the FDA issued an Emergency Use Authorization (EUA) for the Lyra™ Influenza A Subtype H7N9 Assay manufactured by Quidel Corporation. This test is for the presumptive detection of novel influenza A (H7N9) virus (detected in China in 2013) in patients with signs and symptoms of respiratory infection who have positive specimens for influenza A viral RNA that are determined to be un-subtypable.

On April 25, 2014, the FDA issued an Emergency Use Authorization (EUA) for the "A/H7N9 Influenza Rapid Test" manufactured by Arbor Vita Corporation. This test is for the presumptive detection of the influenza A (H7N9) virus (detected in China in 2013) for use by Department of Defense (DoD) network laboratories in the U.S. and outside the U.S. or other U.S. government laboratories outside the U.S. for patients with signs and symptoms of respiratory infection in conjunction with epidemiological risk factors, or foreign laboratories. It is intended for testing U.S. citizens living and traveling abroad in China and other affected areas and for U.S. military, Department of State, and other U.S. governmental agency personnel stationed and working in China and other affected areas who may potentially be exposed to influenza A (H7N9) virus (detected in China in 2013) or be exposed to individuals who may carry the influenza A (H7N9) virus (detected in China in 2013).

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Page Last Updated: 04/28/2016
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