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  1. Emergency Use Authorizations for Medical Devices

Historical Information about Device Emergency Use Authorizations

This page is intended to provide reference information on EUAs that were previously issued, including revoked EUAs.


On this page:

 


Decontamination Systems for Personal Protective Equipment

Decontamination System for PPE Date* Letter of
Authorization
Fact
Sheet
Battelle Decontamination System

03/28/2020 (issued)
01/21/2021 (reissued)
04/30/2021 (revoked)

[Authorization] [Fact Sheet for Healthcare Personnel]
[Instructions for Healthcare Facilities (Closed System)]
[Instructions for Healthcare Personnel (Closed System)]
[Instructions for Healthcare Facilities (Open System)]
[Instructions for Healthcare Personnel (Open System)]

Infusion Pumps

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

Umbrella of Infusion Pumps and Infusion Pump Accessories

On September 21, 2020, FDA has determined that circumstances support revocation of the umbrella EUA to protect the public health or safety. Individual EUAs will allow for tailored indications and scopes of authorization, including but not limited to those for different environments of use, routes of administration, and patient populations. In addition, this would allow for individualized conditions of authorization to address any issue unique to a specific device, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA. Accordingly, FDA has decided to revoke this EUA. Instead, FDA may issue individual EUAs for infusion pumps and infusion pump accessories that meet the requisite EUA statutory criteria. Accordingly, the EUA was revoked under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

05/13/2020
(issued)

09/21/2020
(revoked)

[Authorization] [Healthcare] [Patients]  

In Vitro Diagnostics (IVD)

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

BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)

The FDA issued a De Novo classification order for BioFire Diagnostics, BioFire Respiratory Panel 2.1 (RP2.1) as a Class II device under the generic name "Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test" (to be codified in 21 CFR 866.3981) on March 17, 2021. FDA has concluded that this is an adequate, approved, and available alternative for the BioFire Diagnostics, LLC device which was initially authorized for emergency use in 2020. Accordingly, on March 17, 2021, 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 the BioFire Respiratory Panel 2.1 (RP2.1), issued on May 1, 2020, and revised on December 22, 2020, pursuant to section 564(g)(2) of the Act.

12/22/2020
(issued)

03/17/2021
(revoked)

[Authorization]
[Amendment]
[Healthcare] [Patients] [Labeling]

Anti-SARS-CoV-2 Rapid Test (Autobio Diagnostics Co. Ltd.)

On August 6, 2020, based on FDA's continued review of the scientific evidence available for Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin/ EDTA/ sodium citrate) or serum 2, including evidence from an NIH/NCI independent evaluation, FDA determined that the statutory criteria for the authorization in Section 564(c)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act are no longer met. Specifically, FDA determined that it is not reasonable to believe the product may be effective in detecting IgM antibodies against SARS-CoV-2 or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. FDA also concluded that based on the risks to public health from false test results, revocation is appropriate to protect the public health or safety. Accordingly, the EUA was revoked under Section 564(g)(2)(B) & (C) of the FD&C Act.

04/24/2020 (issued)

08/06/2020 (revoked)

[Authorization] [Healthcare] [Recipients] [Labeling]

DPP COVID-19 IgM/IgG System (Chembio Diagnostic System, Inc.)

On June 16, 2020, FDA revoked the EUA for emergency use of Chembio Diagnostic Systems, Inc.'s DPP COVID-19 IgM/IgG System, which was authorized to detect IgM and IgG antibodies against SARS-CoV-2 in serum and plasma (EDTA or lithium heparin), venous whole blood, or fingerstick whole blood specimens. New information from multiple evaluations of the device's clinical performance were reviewed following authorization and data from these evaluations demonstrated poor clinical performance of the device. Given the poor performance, after consideration of the totality of scientific evidence available to the Agency, FDA determined under section 564(g)(2)(B) that the criteria for issuance of emergency authorization in section 564(c) of the Act were longer met for the DPP COVID-19 IgM/IgG System. Specifically, given the poor device performance, FDA concluded that it was not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the test outweigh its known and potential risks. In addition, based on the same information and the risks to public health from false test results, FDA concluded that revocation is appropriate to protect the public health or safety under section 564(g)(2)(C).

04/14/2020 (issued)

06/16/2020 (revoked)

[Authorization] [Healthcare] [Patients] [Labeling]

DPP Zika IgM Assay System (Chembio Diagnostic Systems, Inc.)

Chembio Diagnostic Systems, Inc.'s ("Chembio") DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (K200506) 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 June 3, 2020. FDA has concluded "that this is an adequate, approved, and available alternative for the Chembio 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 June 3, 2020, 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 DPP Zika IgM Assay System, issued on September 27, 2017, and amended on February 6, 2018, and August 3, 2018, pursuant to section 564(g)(2) of the Act.

8/3/18

[Authorization]
[Amendment]
[Amendment]
 

[Healthcare] [Patients] [Labeling]

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.  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]

LIAISON XL Zika Capture IgM Assay II (DiaSorin Incorporated)

DiaSorin Inc.'s ("DiaSorin's") LIAISON XL Zika Capture IgM II assay (K192046) 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 October 28, 2019. FDA has concluded that this is an adequate, approved, and available alternative for DiaSorin's device which was initially authorized for emergency use in 2017, for purposes of section 564(c)(3) of the Federal Food, Drug and Cosmetic Act (the Act)". As used in section 564(c)(3), the term "approved" refers to a product that is approved, authorized, licensed, or cleared under section 505, 510(k), 513, or 515 of the Act or section 351 of the Public Health Service Act. Accordingly, on October 28, 2019, FDA determined that the criteria for issuance of the Emergency Use Authorization (EUA) under section 564(c) of the Act are no longer met and revoked the EUA for LIAISON XL Zika Capture IgM II assay, issued on April 5, 2017, and amended on November 6, 2017, and December 27, 2018, pursuant to section 564(g)(2) of the Act.

4/5/17 [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]

OraQuick Ebola Rapid Antigen Test (OraSure Technologies, Inc.)

FDA granted the De Novo classification request 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.

03/04/16
(Cadaver)
[Authorization]
[Amendment]
[Response
Team
]
[Relatives
 and
 Caregivers
]
[Labeling]
07/31/15
(Blood)
[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]


Personal Protective Equipment (PPE)

Personal Protective Equipment Date* Letter of
Authorization
Fact
Sheet
Nova2200 for Decontaminating Compatible N95 Respirators (NovaSterilis, Inc.)

08/20/2020 (issued)
02/12/2021 (revoked)

[Authorization] [Fact Sheet for Healthcare Personnel]
[Instructions for Healthcare Facilities]
[Instructions for Healthcare Personnel]
[Instructions for Decontamination Personnel]
Protective Barrier Enclosures 05/01/2020 (issued)
08/20/2020 (revoked)
[Authorization] [Fact Sheet for Healthcare Providers]
[Fact Sheet for Patients]
Disposable N95 Respirators from Strategic National Stockpile 05/01/2009

[Authorization]
[Amendment]

[Fact Sheet]

*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

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