U.S. flag An official website of the United States government
  1. Home
  2. Emergency Preparedness and Response
  3. Counterterrorism and Emerging Threats
  4. Medical Countermeasures Initiative (MCMi)
  5. MCM Legal, Regulatory and Policy Framework
  6. Emergency Use Authorization
  1. MCM Legal, Regulatory and Policy Framework

Emergency Use Authorization

Emergency Use Authorization (EUA) information, and list of all current EUAs

Image
Emergency sign

 

 Español

Skip to list of current EUAs

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies. 

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.

Guidance

In January 2017, FDA finalized the guidance: Emergency Use Authorization of Medical Products and Related Authorities. For more information, please see the January 13, 2017 Federal Register notice.

Printable PDF (288 KB)

In February 2020, FDA issued an Immediately in Effect Guidance on policy for diagnostics testing in laboratories certified to perform high complexity testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the public health emergency. For more information, please see the March 6, 2020, Federal Register notice.

Questions & Answers

  • In March 2020, FDA posted FAQs on Diagnostic Testing for SARS-CoV-2.
  • In January 2014, FDA issued a question and answer document (PDF, 762K) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies.  

Emergency Diagnostics Information

Current EUAs

The tables below provide information on current EUAs:

Information about EUAs that are no longer in effect is available on our EUA archive page.

back to top of page 

Anthrax EUAs

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, doxycycline 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. For additional information, see Emergency Use Authorization--Archived Information.

back to list of current EUAs

Coronavirus Disease 2019 (COVID-19) EUA Information

Coronavirus Disease (COVID-19) updates from FDA

In Vitro Diagnostic Products 

On February 4, 2020, the HHS Secretary determined that there is 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 the virus that causes COVID-19.  On the basis of this determination, the Secretary then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19.

CDC has granted a right of reference to the performance data contained in CDC’s EUA request (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.

On February 29, 2020, the FDA issued an immediately in effect guidance with policy specific to this public health emergency. The templates for these EUA submissions are available:

If you need additional information, please refer to the FAQs on Diagnostic Testing for SARS-CoV-2.

Please note: A determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue Emergency Use Authorizations. A separate determination and declaration are needed under section 564 of the Federal Food, Drug, and Cosmetic Act to enable FDA to issue Emergency Use Authorizations, provided other statutory criteria are met.

For more information on the Emergency Use Authorizations listed below, see Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.

Test Kit Manufacturers and Commercial Laboratories
In Vitro Diagnostic 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)
CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC) February 4, 2020 (initial issuance)

March 15, 2020 (reissuance)
Letter of Authorization (PDF, 286 KB)

Letter Granting EUA Amendments (March 30, 2020) (PDF, 66 KB)
  Healthcare (PDF, 144 KB)

Patients (PDF, 121 KB)

Instructions for Use (PDF, 1..7 MB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Wadsworth Center, NYSDOH) February 29, 2020 (initial issuance) March 10, 2020 (reissuance) March 15, 2020 (amendments granted) Letter of Authorization  (PDF, 312 KB)

Letter Granting EUA Amendment(s), March 15, 2020 (PDF, 63 KB)
  Healthcare (PDF, 140 KB)

Patients (PDF, 117 KB)

Instructions for Use (PDF, 314 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
cobas SARS-CoV-2 (Roche Molecular Systems, Inc. (RMS)) March 12, 2020 Letter of Authorization (PDF, 111 KB)

Letter Granting EUA Amendment (March 31, 2020) (PDF, 146 KB)
  Fact Sheet for Healthcare  Providers (PDF, 129 KB)

Fact Sheet for Patients (PDF, 117 KB)

Manufacturer Instructions/ Package  (PDF, 1.4 MB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.) March 13, 2020 Letter of Authorization (PDF, 105 KB)

Letter Granting EUA Amendment(s) (March 24, 2020) (PDF, 64 KB)
  Fact Sheet for Healthcare Providers (PDF, 135 KB)

Fact Sheet for Patients (PDF, 122 KB)

Manufacturer Instructions/ Package (PDF, 269 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Panther Fusion SARS-CoV-2 (Hologic, Inc.) March 16, 2020 Letter of Authorization (PDF, 290 KB)    Fact Sheet for Healthcare Providers (PDF, 135 KB)

Fact Sheet for Patients (PDF, 124 KB)

Manufacturer Instructions/ Package (PDF, 423 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
COVID-19 RT-PCR Test (Laboratory Corporation of America) March 16, 2020 Letter of Authorization (PDF, 296 KB)   Fact Sheet for Healthcare Providers (PDF, 138 KB)

Fact Sheet for Patients (PDF, 122 KB)

EUA Summary (PDF, 426 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Lyra SARS-CoV-2 Assay (Quidel Corp.) March 17, 2020 Letter of Authorization (PDF, 294 KB) 

Letter Granting EUA Amendment(s) (March 23, 2020) (PDF, 136 KB)
  Fact Sheet for Healthcare Providers (PDF, 133 KB)

Fact Sheet for Patients (PDF, 121 KB)

Manufacturer Instructions/ Package Insert (PDF, 479 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Quest SARS-CoV-2 rRT-PCR (Quest Diagnostics Infectious Disease, Inc.) March 17, 2020

Letter of Authorization (PDF, 297 KB)

Letter Granting EUA Amendment(s) (March 26, 2020) (PDF - 137 KB)

  Fact Sheet for Healthcare Providers (PDF, 135 KB)

Fact Sheet for Patients (PDF, 123 KB)

Manufacturer Instructions/ Package Insert (PDF, 234 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Abbott RealTime SARS-CoV-2 assay (Abbott Molecular) March 18, 2020 Letter of Authorization  (PDF, 324 KB)   Fact Sheet for Healthcare Providers (PDF, 155 KB)

Fact Sheet for Patients (PDF, 144 KB)

Manufacturer Instructions/ Package Insert (PDF, 351 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Simplexa COVID-19 Direct (DiaSorin Molecular LLC) March 19, 2020 Letter of Authorization (PDF, 103 KB)

Letter Granting EUA Amendment(s) (March 26, 2020) (PDF, 136 KB)
  Fact Sheet for Healthcare Providers (PDF, 135 KB)

Fact Sheet for Patients (PDF, 122 KB)

Manufacturer Instructions/ Package Insert (PDF, 291 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
ePlex SARS-CoV-2 Test (GenMark Diagnostics, Inc.) March 19, 2020 Letter of Authorization (PDF, 126 KB)   Fact Sheet for Healthcare Providers (PDF, 143 KB)

Fact Sheet for Patients (PDF, 128 KB)

anufacturer Instructions/ Package Insert (PDF, 257 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Primerdesign Ltd COVID-19 genesig Real-Time PCR assay (Primerdesign Ltd) March 20, 2020 Letter of Authorization (PDF, 132 KB)   Fact Sheet for Healthcare Providers (PDF, 137 KB)

Fact Sheet for Patients (PDF, 125 KB)

Manufacturer Instructions/ Package Insert (PDF, 1,013 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Xpert Xpress SARS-CoV-2 test (Cepheid) March 20, 2020 Letter of Authorization (PDF, 140  KB)   Fact Sheet for Healthcare Providers (PDF, 135 KB)

Fact Sheet for Patients (PDF, 121 KB)

Manufacturer Instructions/ Package Insert - Laboratories (PDF, 310 KB)

Manufacturer Instructions/ Package Insert - Point of Care (PDF, 1.47 MB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
BioFire COVID-19 Test (BioFire Defense, LLC) March 23, 2020 Letter of Authorization (PDF, 317  KB)   Fact Sheet for Healthcare Providers (PDF, 135 KB)

Fact Sheet for Patients (PDF, 123 KB)

Manufacturer Instructions/ Package Insert (PDF, 3.44 MB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Accula SARS-Cov-2 Test (Mesa Biotech Inc.) March 23, 2020 Letter of Authorization (PDF, 322  KB)   Fact Sheet for Healthcare Providers (PDF, 135 KB)

Fact Sheet for Patients (PDF, 123 KB)

Manufacturer Instructions/ Package Insert (PDF, 2.29 MB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
PerkinElmer New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.) March 24, 2020 Letter of Authorization (PDF, 319  KB)

Letter Granting EUA Amendment(s)  (April 1, 2020) (PDF, 136 KB)
  Fact Sheet for Healthcare Providers (PDF, 133 KB)

Fact Sheet for Patients (PDF, 121 KB)

Manufacturer Instructions/ Package Insert (PDF, 374 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
AvellinoCoV2 test (Avellino Lab USA, Inc.) March 25, 2020 Letter of Authorization (PDF, 284 KB)   Fact Sheet for Healthcare Providers (PDF, 139 KB)

Fact Sheet for Patients (PDF, 120 KB)

EUA Summary (PDF, 135 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV (BGI Genomics Co. Ltd) March 26, 2020 Letter of Authorization (PDF, 131 KB)   Fact Sheet for Healthcare Providers (PDF, 163 KB)

Fact Sheet for Patients (PDF, 151 KB)

Manufacturer Instructions/ Package Insert (PDF, 1.07 MB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
ID NOW COVID-19 (Abbott Diagnostics Scarborough, Inc.) March 27, 2020 Letter of Authorization (PDF, 356 KB)   Fact Sheet for Healthcare Providers (PDF, 137 KB)

Fact Sheet for Patients (PDF, 124 KB)

Manufacturer Instructions/ Package Insert (PDF, 2.95 MB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
NxTAG CoV Extended Panel Assay (Luminex Molecular Diagnostics, Inc. Luminex Molecular Diagnostics, Inc.) March 27, 2020 Letter of Authorization (PDF, 318 KB)   Fact Sheet for Healthcare Providers (PDF, 136 KB)

Fact Sheet for Patients (PDF, 123 KB)

Manufacturer Instructions/ Package Insert (PDF, 768 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
NeuMoDx SARS-CoV-2 Assay (NeuMoDx Molecular, Inc.) March 30, 2020 Letter of Authorization (PDF,  127 KB)

 
  Fact Sheet for Healthcare Providers (PDF, 135 KB)

Fact Sheet for Patients (PDF, 124 KB)

Manufacturer Instructions/ Package Insert (PDF, 441 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAGEN GmbH) March 30, 2020 Letter of Authorization (PDF,  128 KB)   Fact Sheet for Healthcare Providers (PDF, 140 KB)

Fact Sheet for Patients (PDF, 124 KB)

Manufacturer Instructions/ Package Insert (PDF, 1.81 MB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Cellex Inc. qSARS-CoV-2 IgG/IgM Rapid Test (Cellex Inc.)
 
April 1, 2020 Letter of Authorization (PDF, 328 KB)   Fact Sheet for Healthcare Providers (PDF, 136 KB)

Fact Sheet for Patients (PDF, 123 KB)

Manufacturer Instructions/ Package Insert (PDF, 319 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
COV-19 IDx assay (Ipsum Diagnostics, LLC) April 1, 2020 Letter of Authorization (PDF, 288 KB)   Fact Sheet for Healthcare Providers (PDF, 133 KB)

Fact Sheet for Patients (PDF, 121 KB)

EUA Summary (PDF, 130 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
BioGX SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson & Company (BD)) April 2, 2020 Letter of Authorization (PDF, 154 KB)   Fact Sheet for Healthcare Providers (PDF, 143 KB)

Fact Sheet for Patients (PDF, 131 KB)

Manufacturer Instructions/ Package Insert (PDF, 1.68 MB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
ARIES SARS-CoV-2 Assay (Luminex Corporation) April 3, 2020 Letter of Authorization (PDF, 125 KB)   Fact Sheet for Healthcare Providers (PDF, 138 KB)

Fact Sheet for Patients (PDF, 124 KB)
Manufacturer Instructions/ Package Insert (PDF, 739 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit (ScienCell Research Laboratories) April 3, 2020 Letter of Authorization (PDF, 319 KB)   Fact Sheet for Healthcare Providers (PDF, 141 KB)

Fact Sheet for Patients (PDF, 129 KB)

Manufacturer Instructions/ Package Insert (PDF, 376 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (Co-Diagnostics, Inc.) April 3, 2020 Letter of Authorization (PDF, 317 KB)   Fact Sheet for Healthcare Providers (PDF, 135 KB)

Fact Sheet for Patients (PDF, 123 KB)

Manufacturer Instructions/ Package Insert (PDF, 476 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Gnomegen COVID-19 RT-Digital PCR Detection Kit (Gnomegen LLC) April 6, 2020 Letter of Authorization (PDF,  320 KB)   Fact Sheet for Healthcare Providers (PDF, 135 KB)

Fact Sheet for Patients (PDF, 123 KB)

Manufacturer Instructions/ Package Insert (PDF, 227 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)

High Complexity Molecular-Based Laboratory Developed Tests

On March 31, 2020, the FDA concluded based on the totality of scientific evidence available that molecular-based laboratory developed tests (LDTs) that are authorized for use by the singular developing laboratory are appropriate to protect the public health or safety (as described under the Scope of Authorization (Section II)) under section 564 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360bbb-3). Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests.

High Complexity Molecular-Based Laboratory Developed Tests
Molecular-Based Laboratory Developed Test Laboratory Date of EUA Issuance Letter Granting Inclusion Under EUA EUA Summary
SARS-CoV-2 PCR test Yale New Haven Hospital,
Clinical Virology Laboratory
March 31, 2020 Letter Granting Inclusion (PDF, 72 KB) EUA Summary (PDF,  121 KB)
SARS-CoV-2 RT-PCR test Infectious Disease Diagnostics Laboratory - Children’s Hospital of Philadelphia April 2, 2020 Letter Granting Inclusion (PDF,  121 KB) EUA Summary (PDF, 333  KB)
SARS-Cov-2 Assay Diagnostic Molecular Laboratory – Northwestern Medicine April 2, 3030 Letter Granting Inclusion (PDF, 152 KB) EUA Summary (PDF, 272 KB)
MGH COVID-19 qPCR assay Massachusetts General Hospital April 3, 2020 Letter Granting Inclusion (PDF, 68 KB) EUA Summary (PDF, 122 KB)
Viracor SARS-CoV-2 assay  Viracor Eurofins Clinical Diagnostics April 6, 2020 Letter Granting Inclusion (PDF 120 KB) EUA Summary (PDF, 65 KB)

Personal Protective Equipment

On February 4, 2020, the HHS Secretary determined that there is 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 the virus that causes COVID-19.  On the basis of this determination, the HHS Secretary declared on March 2, 2020, that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak.

Manufacturers and strategic stockpilers are able to submit a request to FDA in order to have their products added to the EUA. 

For additional information, please see Recent Final Medical Device Guidance Documents and Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers.

For more information on the Emergency Use Authorizations listed below, see Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.

Personal Protective Equipment Date of EUA Issuance Letter of Authorization Federal Register Notice for EUA Information for Manufacturers and Strategic Stockpilers EUA Determination and Declaration (Effective Date) PREP Act Declaration (if applicable)
NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency March 2, 2020

March 27, 2020 (reissuance)

March 28, 2020 (reissuance)
Letter of Authorization (PDF, 232 KB)

EUA Clarification Letter on Respirators (PDF, 49 KB)
  Manufacturers of authorized respirators do not need to submit attestation to the FDA to request authorization.  

Strategic stockpilers of authorized expired filtering facepiece respirators (FFRs) do not need to submit a request to the FDA to request authorization.
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020)

Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (PDF, 42 KB) (March 2, 2020)
Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators March 24, 2020

March 28, 2020 (reissuance)
Letter of Authorization (PDF, 208 KB)   Non-NIOSH Approved Respirator EUA FAQ Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020)

Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (PDF, 42 KB) (March 2, 2020)
Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Battelle Decontamination System  March 28, 2020

March 29, 2020 (reissuance)
Letter of Authorization (PDF, 151 KB)   Fact Sheet for Healthcare Providers (PDF, 273 KB)

Instructions for Healthcare Facilities (PDF, 212 KB)

Instructions for Healthcare Personnel (PDF, 183 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020)

Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (PDF, 42 KB) (March 2, 2020)
Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China April 3, 2020 Letter of Authorization (PDF, 255 KB)   Appendix A: Authorized Respirators (PDF, 104 KB) Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF, 159 KB) (February 4, 2020)

Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (PDF, 42 KB) (March 2, 2020)
Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)

Other Medical Devices

In continuing response to the COVID-19 pandemic, on March 24, 2020, and based on the February 4, 2020 HHS EUA determination, the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak.

Manufacturers and other stakeholders are able to submit a request to FDA in order to have their products added to the EUA. 

Please see Recent Final Medical Device Guidance Documents for additional information..

For more information on the Emergency Use Authorizations listed below, see Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.

Medical Device 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)
Ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories March 24, 2020 Letter of Authorization (PDF, 359 KB)

Appendix A: Criteria for Safety, Performance and Labeling (PDF, 214 KB)

Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories (Updated April 4, 2020) (PDF, 129 KB)
  Fact Sheet for Healthcare Providers (PDF, 133 KB)

Fact Sheet for Patients (PDF, 126 KB)
Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (PDF,  147 KB) (March 24, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)

Therapeutics

On March 28, 2020, FDA issued an EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products  donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19. These drugs will be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible. The EUA requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions. The SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states.

Therapeutic 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)
Chloroquine phosphate and hydroxychloroquine sulfate for treatment of COVID-19 March 28, 2020 Letter of Authorization (PDF, 229 KB)

 
  Chloroquine Phosphate Fact Sheet for Healthcare Providers (PDF, 217 KB)

Chloroquine Phosphate Fact Sheet for Patients (PDF, 147 KB)

Hydroxychloroquine Sulfate Fact Sheet for Healthcare Providers (PDF, 206 KB)

Hydroxychloroquine Sulfate Fact Sheet for Patients (PDF, 148 KB)
Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (PDF, 119 KB) (March 27, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)

back to list of current EUAs

Ebola Virus EUA Information

Ebola preparedness and response updates from FDA (all agency activities)

For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).

Ebola Diagnostic Tests with De Novo, 510(k) or PMA

  • OraQuickEbola Rapid Antigen Test - On October 10, 2019, FDA allowed marketing (PDF, 255 KB) of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for Ebola virus disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed. Also see the FDA news release: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens

    The OraQuick Ebola Test was reviewed under the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this marketing authorization, the FDA is establishing criteria, called special controls, that determine the requirements for demonstrating accuracy, reliability and effectiveness of tests intended to identify Ebola virus antigens. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
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)

EZ1 Real-time RT-PCR Assay 
(DoD)

August 5, 2014 (initial issuance)

October 10, 2014 (reissuance)

 

Authorization (PDF, 61 KB)

 FR notice

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014)

 

CDC Ebola Virus NP Real-time RT-PCR Assay 
(CDC)

October 10, 2014 (initial issuance) 

March 2, 2015 (reissuance)

October 8, 2019 (amended)

 

Authorization (PDF, 282 KB)

Letter granting EUA amendment(s) (PDF, 134 KB)

 FR notice

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014)

 

CDC Ebola Virus VP40 Real-time RT-PCR Assay 
(CDC)

October 10, 2014 (initial issuance) 

March 2, 2015 (reissuance)

October 8, 2019 (amended)

 

Authorization (PDF, 285 KB)

Letter granting EUA amendment(s) (PDF, 135 KB)

 FR notice

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014)

 

FilmArray NGDS BT-E Assay 
(Biofire Defense, LLC)

October 25, 2014 (initial issuance) 

March 2, 2015 (reissuance)

 

Authorization (PDF, 326 KB)

 FR notice

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014)

 

FilmArray Biothreat-E test 
(Biofire Defense, LLC)

October 25, 2014 

November 12, 2019 (amended) 

Authorization (PDF,  73 KB)       

Letter granting EUA amendment(s) (PDF, 152 KB)

 FR notice

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014)

 

RealStar Ebolavirus RT-PCR Kit 1.0 
(altona Diagnostics, GmbH)

November 10, 2014 (initial issuance)

November 26, 2014 (reissuance)  

 

Authorization (PDF,  263 KB)

 FR notice

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014)

 

LightMix Ebola Zaire rRT-PCR Test 
(Roche Molecular Systems, Inc.)

December 23, 2014

Authorization (PDF,  2.2 MB)

 FR notice

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014)

 

Xpert Ebola Assay
(Cepheid)

March 23, 2015

Authorization (PDF,  240 KB)

 FR notice

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014)

 

Idylla Ebola Virus Triage Test (Biocartis NV)

May 26, 2016

Authorization  (PDF,  321 KB)

 FR notice

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014)

 

DPP Ebola Antigen System (Chembio Diagnostic Systems, Inc.)

November 9, 2018

April 2, 2019 (amended)

Authorization  (PDF,  103 KB)

Letter Granting EUA Amendment(s) (PDF, 87 KB)

FR notice

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014)

 

back to list of current EUAs

Enterovirus D68 (EV-D68) EUA Information

For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).

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)

CDC Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR)

May 12, 2015

Authorization (PDF, 229 KB)

 FR notice

Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 (February 6, 2015)

 

back to list of current EUAs

Freeze Dried Plasma Information

Also see FDA News Release: FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product (July 10, 2018)

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)

Pathogen-Reduced Leukocyte-Depleted Freeze Dried Plasma (Centre de Transfusion Sanguine des Armées)

 

July 9, 2018

Authorization (PDF,  203 KB)

 FR notice

Determination by DoD (June 7, 2018)

Declaration Regarding Emergency Use of Treatment for Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat (July 9, 2018)

 

back to list of current EUAs

H7N9 Influenza EUA Information

For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).

Medical Product Date of EUA Issuance Letter of Authorization Federal Register Notice for EUA Fact Sheet and Manufacturer Instructions/Package Insert EUA Determination and Declaration (Effective Date) PREP Act Declaration (if applicable) 

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay
 

April 22, 2013 (initial issuance)

 

March 27, 2018 (reissuance)

Authorization  (PDF, 301 KB), re-issued March 27, 2018

 

FR notice

Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013)

Additional information from HHS

Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.)

Quidel Lyra Influenza A Subtype H7N9 Assay

February 14, 2014

Authorization (PDF, 57 KB)

FR notice

Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013)

Additional information from HHS

Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.)

A/H7N9 Influenza Rapid Test

April 25, 2014

Authorization

FR notice

Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013)

Additional information from HHS

Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.)

back to list of current EUAs

Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information

For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).

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)

CDC Novel Coronavirus 2012 Real-time RT-PCR Assay

June 5, 2013 (initial issuance)

June 10, 2014 (reissuance)

 

 

Authorization (PDF, 2.2 MB)

FR notice

Determination and Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) (May 29, 2013)

Additional information from HHS

 

RealStar MERS-CoV RT-PCR Kit U.S.

July 17, 2015
(initial issuance)

February 12, 2016 (reissuance)

 

 

Authorization (PDF, 238 KB)

 FR notice

Determination and Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) (May 29, 2013)

Additional information from HHS

 

 back to list of current EUAs

Nerve Agent EUA Information

On July 9, 2018, FDA approved (PDF,  49 KB) the 2 mg Atropine Auto-Injector manufactured by Rafa Laboratories, Ltd., for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides in adults and pediatric patients weighing over 90 lbs [41 kg] (generally over 10 years of age). For more information about the approved 2 mg Rafa Atropine Auto-Injector, see the product label (PDF, 482 KB). The EUA detailed in the table below is still in effect.

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)

Atropine Auto-Injector (Rafa Laboratories Ltd.)

April 11, 2017 (initial issuance)

May 23, 2017 (amended)

January 24, 2018 (amended)

March 6, 2018 (amended)

May 15, 2018 (amended)

Letter of Authorization (PDF,  514 KB)

Letter granting EUA amendment(s) (PDF, 28 KB)

2nd letter granting EUA amendment(s) (PDF, 33 KB)

3rd letter granting EUA amendment(s) (PDF, 85 KB)

4th letter granting EUA amendment(s) (PDF, 42 KB)

FR
notice

 

Determination and Declaration Regarding Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning (April 11, 2017)

Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures (April 11, 2017)

back to list of current EUAs

Zika Virus EUA Information

Zika virus response updates from FDA

Zika virus diagnostic development information

For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).

Draft EUA review templates for Zika are available by email request to: CDRH-ZIKA-Templates@fda.hhs.gov

Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.

Zika Diagnostic Tests with De Novo, 510(k), or PMA

  • ZIKV Detect 2.0 IgM Capture ELISA - On May 23, 2019, FDA authorized marketing (PDF, 175 KB) of the ZIKV Detect 2.0 IgM Capture ELISA to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S.; previously, tests for detecting Zika virus IgM antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—had been authorized only for emergency use under the FDA’s EUA authority. Also see the FDA news release: FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
  • ADVIA Centaur Zika test – On July 17, 2019, FDA cleared the ADVIA Centaur Zika test. This is the second Zika diagnostic test FDA has allowed to be marketed in the U.S. for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.
  • LIAISON XL Zika Capture IgM Assay II – On October 28, 2019, FDA cleared the LIAISON XL Zika Capture IgM Assay II for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.
Medical Product Date of EUA Issuance Letters Federal Register Notice for EUA

Fact Sheets and Manufacturer Instructions/Package Insert

EUA Determination and Declaration (Effective Date) PREP Act Declaration (if applicable)

CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay

CDC statement on this EUA

February 26, 2016 (initial issuance)

June 29, 2016 (amended)

November 15, 2016 (amended)

December 6, 2016 (amended)

May 3, 2017 (amended)

July 31, 2017 (amended)

April 16, 2018 (amended)

September 26, 2018 (amended)

Letter granting EUA amendment(s) (PDF, 155 KB)

Letter granting EUA amendment(s) (PDF, 123 KB)

Letter granting EUA amendment(s) (PDF, 110 KB)

Letter granting EUA amendment(s) (PDF, 113 KB)

Letter granting EUA amendment(s) (PDF, 131 KB)

Letter granting EUA amendment(s) (PDF, 131 KB)

 FR notice

 Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR)

CDC statement on this EUA

March 17, 2016 (initial issuance)

September 21, 2016 (amended)

January 12, 2017 (amended)

February 28, 2017 (amended)

April 6, 2017 (amended)

Authorization (PDF, 82 KB)

Letter granting EUA amendment(s) (PDF, 223 KB)

Letter granting EUA amendment(s) (PDF, 223 KB)

Letter granting EUA amendment(s) (PDF, 223 KB)

Letter granting EUA amendment(s) (PDF, 126 KB)

 FR notice

 Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

Zika Virus RNA Qualitative Real-Time RT-PCR (Quest Diagnostics Infectious Disease, Inc.)

April 28, 2016 (initial issuance)

October 7, 2016 (reissuance)

April 11, 2017 (amended)

Authorization  (PDF, 339 KB)

Letter granting EUA amendment(s) (PDF, 126 KB)

 FR notice

 Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

RealStar Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH)

May 13, 2016 (initial issuance)

October 31, 2016 (amended)

March 6, 2017 (amended)

Authorization (PDF, 342 KB)

Letter Granting EUA Amendment(s) (PDF, 130 KB)

Letter Granting EUA Amendment(s) (PDF, 130 KB)

 FR notice

 Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

Aptima Zika Virus assay (Hologic, Inc.)

June 17, 2016 (initial issuance)

September 7, 2016 (amended)

April 12, 2017 (amended)

March 8, 2018 (amended)

 

Authorization (PDF, 305 KB)

Letter granting EUA amendment(s) (PDF, 126 KB)

Letter granting EUA amendment(s) (PDF, 124 KB)

Letter granting EUA amendment(s) (PDF, 130 KB)

 

 FR notice

 Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

Zika Virus Real-time RT-PCR Test (Viracor Eurofins)

July 19, 2016 (initial issuance)

February 28, 2017 (amended)

Authorization (PDF, 334 KB)

Letter granting EUA amendment(s) (PDF, 124 KB)

 FR notice

 Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

VERSANT Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics Inc.)

July 29, 2016 (initial issuance)

December 19, 2016 (amended)

Authorization (PDF, 78 KB)

Letter granting EUA amendment(s) (PDF, 124 KB)

 FR notice

 Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

Sentosa SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.)

September 23, 2016

Authorization (PDF,  355 KB)

 FR notice

 Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

Zika Virus Detection by RT-PCR Test (ARUP Laboratories)

September 28, 2016

Authorization (PDF,  98 KB)

 FR notice

Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

Abbott RealTime ZIKA (Abbott Molecular Inc.)

November 21, 2016 (initial issuance)

January 6, 2017 (amended)

Authorization (PDF, 84 KB)

Letter granting EUA amendment(s) (PDF, 150 KB)

 FR notice

Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)

December 9, 2016

Authorization (PDF, 312 KB)

 FR notice

Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

Gene-RADAR Zika Virus Test (Nanobiosym Diagnostics, Inc.)

March 20, 2017

Authorization (PDF, 313 KB)

 FR notice

Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

TaqPath Zika Virus Kit (Thermo Fisher Scientific)

August 2, 2017

Authorization (PDF, 292 KB)

 FR notice

Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

 

CII-ArboViroPlex rRT-PCR Assay (Columbia University)

August 11, 2017

Authorization (PDF, 377 KB)

 FR notice

Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

 


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

September 27, 2017 (initial issuance)

February 6, 2018 (amended)

August 3, 2018 (amended)

Authorization (PDF, 424 KB)

Letter granting EUA amendment(s) (PDF, 130 KB)

Letter granting EUA amendment(s) (PDF, 129  KB)

 FR notice

Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)

 

 back to list of current EUAs

Related Links

 

Subscribe

Sign up to receive email alerts on emergency preparedness and response topics from FDA, including EUA updates.