Emergency Use Authorization (Eua) Information, and List of All Current Euas

02/04/2020 Emergency Use Authorization | FDA
Emergency Use Authorization

Emergency Use Authorization (EUA) information, and list of all current EUAs
Español (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/autorizacion-de-uso-de-emergencia)
Skip to list of current EUAs (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#current)
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 (/federal-food-drug-and-cosmetic-act-fdc-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 (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-
counterterrorism-legislation#bioshield) and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (/emergency-preparedness-and-
response/mcm-legal-regulatory-and-policy-framework/pandemic-and-all-hazards-preparedness-reauthorization-act-2013-pahpra) (PAHPRA), the 21st Century Cures Act (/emergency-
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization 1/27
preparedness-and-response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation#21CC) of 2016, and Public Law 115-92 (/emergency-preparedness-and-
response/mcm-legal-regulatory-and-policy-framework/mcm-related-counterterrorism-legislation#PL11592) of 2017.
Guidance
In January 2017, FDA nalized the guidance: Emergency Use Authorization of Medical Products and Related Authorities (/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-
medical-products-and-related-authorities). For more information, please see the January 13, 2017 Federal Register notice (https://www.federalregister.gov/documents/2017/01/13/2017-00721/emergency-use-
authorization-of-medical-products-and-related-authorities-guidance-for-industry-and).
Printable PDF (288 KB) (/media/97321/download)
In February 2020, FDA issued an Immediately in Effect Guidance on policy for diagnostics testing (/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-
during-public-health-emergency) in laboratories certi ed 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 (https://www.federalregister.gov/documents/2020/03/06/2020-04630/policy-for-diagnostics-testing-in-laboratories-certi ed-to-
perform-high-complexity-testing-under).
Questions & Answers

In March 2020, FDA posted FAQs on Diagnostic Testing for SARS-CoV-2 (/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2).
In January 2014, FDA issued a question and answer document (/media/87718/download) (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

Emergency Use Authorizations (/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations) (current device EUAs)
How to Submit a Pre-EUA for In vitro Diagnostics (IVDs) to FDA (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/how-submit-pre-eua-vitro-
diagnostics-fda) (for test manufacturers)
Information for Laboratories Implementing IVD Tests Under EUA (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/information-laboratories-
implementing-ivd-tests-under-eua)
Current EUAs
The tables below provide information on current EUAs:
Anthrax EUAs
Coronavirus Disease 2019 (COVID-19) EUA Information
Ebola Virus EUA Information (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#ebola)

Enterovirus D68 (EV-D68) EUA Information (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#enterovirus)
Freeze Dried Plasma Information (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#FrenchFDP)
H7N9 Influenza EUA Information (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#H7N9)
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-
use-authorization#MERS)
Nerve Agent EUA Information (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#nerveagents)
Zika Virus EUA Information (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#zika)
Information about EUAs that are no longer in effect is available on our EUA archive page (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-
use-authorization-archived-information).
back to top of page (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#top)
Anthrax EUAs
The 2016 FDA Doxycycline Emergency Dispensing Order (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-dispensing-orders#doxy) and CDC Doxycycline
Emergency Use Instructions (EUI) (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-dispensing-orders#doxy) 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 (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-
authorization-archived-information).
back to list of current EUAs (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#current)
Coronavirus Disease 2019 (COVID-19) EUA Information

Coronavirus Disease (COVID-19) updates from FDA (/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19)
In Vitro Diagnostic Products

Personal Protective Equipment
Other Medical Devices
Therapeutics
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 (/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-
during-public-health-emergency) with policy specific to this public health emergency. The templates for these EUA submissions are available:
“Accelerated” Template for Laboratories Certified to Perform High-Complexity Testing Under CLIA: EUA Template (/media/135658/download) (updated March 6, 2020)
Test Kit Manufacturer: EUA Template (/media/135900/download) (updated March 12, 2020)
If you need additional information, please refer to the FAQs on Diagnostic Testing for SARS-CoV-2 (/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-
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
(https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx), 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 (https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-
authorizations#coronavirus2019), see Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.
Test Kit Manufacturers and Commercial Laboratories

Federal
In Vitro Register
Diagnostic Date of EUA Notice for Fact Sheets and Manufacturer EUA Determination and
Product Issuance Letter of Authorization EUA Instructions/ Package Insert Declaration (Effective Date) PREP Act Declaration (if applicable)
CDC 2019-Novel February 4, Letter of Authorization Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
Coronavirus 2020 (initial (/media/134919/download)(PDF, (/media/134920/download) (PDF, Emergency and Declaration that for medical countermeasures against COVID-19
(2019-nCoV) issuance) 286 KB) 144 KB) Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Real-Time RT- Authorizations Pursuant to 4, 2020)
PCR Diagnostic March 15, Letter Granting EUA Patients Section 564(b) of the FD&C Act
Panel (CDC) 2020 Amendments (March 30, 2020) (/media/134921/download) (PDF, (/media/135010/download)(PDF,
(reissuance) (/media/136572/download) 121 KB) 159 KB) (February 4, 2020)
(PDF, 66 KB)
Instructions for Use
(/media/134922/download) (PDF,
1..7 MB)
New York SARS- February 29, Letter of Authorization Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
CoV-2 Real-time 2020 (initial (/media/135661/download) (/media/135662/download)(PDF, Emergency and Declaration that for medical countermeasures against COVID-19
Reverse issuance) (PDF, 312 KB) 140 KB) Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Transcriptase March 10, Authorizations Pursuant to 4, 2020)
(RT)-PCR 2020 Letter Granting EUA Patients Section 564(b) of the FD&C Act
Diagnostic Panel (reissuance) Amendment(s), March 15, 2020 (/media/135663/download) (PDF, (/media/135010/download)(PDF,
(Wadsworth March 15, (/media/136122/download) 117 KB) 159 KB) (February 4, 2020)
Center, NYSDOH) 2020 (PDF, 63 KB)
(amendments Instructions for Use
granted) (/media/135847/download) (PDF,
314 KB)
cobas SARS- March 12, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
CoV-2 (Roche 2020 (/media/136046/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
Molecular (PDF, 111 KB) (/media/136047/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Systems, Inc. 129 KB) Authorizations Pursuant to 4, 2020)
(RMS)) Letter Granting EUA Amendment Section 564(b) of the FD&C Act
(March 31, 2020 Fact Sheet for Patients (/media/135010/download)(PDF,
(/media/136589/download)) (/media/136048/download) (PDF, 159 KB) (February 4, 2020)
(PDF, 146 KB) 117 KB)
Manufacturer Instructions/
Package
1.4 MB)
Federal
In Vitro Register
TaqPath COVID- March 13, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
19 Combo Kit 2020 (/media/136113/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
(Thermo Fisher (PDF, 105 KB) (/media/136111/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Scienti c, Inc.) 135 KB) Authorizations Pursuant to 4, 2020)
Letter Granting EUA Section 564(b) of the FD&C Act
Amendment(s) (March 24, 2020) Fact Sheet for Patients (/media/135010/download)(PDF,
(/media/136413/download) (/media/136114/download) (PDF, 159 KB) (February 4, 2020)
(PDF, 64 KB) 122 KB)
Package
269 KB)
Panther Fusion March 16, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
SARS-CoV-2 2020 (/media/136153/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
(Hologic, Inc.) (PDF, 290 KB) (/media/136154/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
135 KB) Authorizations Pursuant to 4, 2020)
Section 564(b) of the FD&C Act
Fact Sheet for Patients (/media/135010/download)(PDF,
(/media/136155/download) (PDF, 159 KB) (February 4, 2020)
124 KB)
Package
423 KB)
COVID-19 RT- March 16, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
PCR Test 2020 (/media/136148/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
(Laboratory (PDF, 296 KB) (/media/136149/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Corporation of 138 KB) Authorizations Pursuant to 4, 2020)
America) Section 564(b) of the FD&C Act
122 KB)
EUA Summary
426 KB)
Federal
In Vitro Register
Lyra SARS-CoV-2 March 17, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
Assay (Quidel 2020 (/media/136224/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
Corp.) (PDF, 294 KB) (/media/136226/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
(PDF, 136 KB) 121 KB)
Package Insert
479 KB)
Quest SARS- March 17, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
CoV-2 rRT-PCR 2020 (/media/136228/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
(Quest (PDF, 297 KB) (/media/136229/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Diagnostics 135 KB) Authorizations Pursuant to 4, 2020)
Infectious Section 564(b) of the FD&C Act
Letter Granting EUA
Disease, Inc.) Fact Sheet for Patients (/media/135010/download)(PDF,
Amendment(s) (March 26, 2020)
(/media/136487/download) (PDF 123 KB)
- 137 KB)
Package Insert
234 KB)
Abbott RealTime March 18, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
SARS-CoV-2 2020 (/media/136255/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
assay (Abbott (PDF, 324 KB) (/media/136256/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Molecular) 155 KB) Authorizations Pursuant to 4, 2020)
144 KB)
Package Insert
351 KB)
Federal
In Vitro Register
Simplexa COVID- March 19, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
19 Direct 2020 (/media/136288/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
(DiaSorin (PDF, 103 KB) (/media/136285/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Molecular LLC) 135 KB) Authorizations Pursuant to 4, 2020)
(PDF, 136 KB) 122 KB)
Package Insert
291 KB)
ePlex SARS-CoV- March 19, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
2 Test (GenMark 2020 (/media/136283/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
Diagnostics, (PDF, 126 KB) (/media/136281/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Inc.) 143 KB) Authorizations Pursuant to 4, 2020)
128 KB)
anufacturer Instructions/
Package Insert
257 KB)
Primerdesign March 20, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
Ltd COVID-19 2020 (/media/136306/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
genesig Real- (PDF, 132 KB) (/media/136308/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Time PCR assay 137 KB) Authorizations Pursuant to 4, 2020)
(Primerdesign Section 564(b) of the FD&C Act
Ltd) Fact Sheet for Patients (/media/135010/download)(PDF,
125 KB)
Package Insert
1,013 KB)
Federal
In Vitro Register
Xpert Xpress March 20, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
SARS-CoV-2 test 2020 (/media/136316/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
(Cepheid) (PDF, 140 KB) (/media/136313/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
121 KB)
Package Insert - Laboratories
310 KB)
Package Insert - Point of Care
1.47 MB)
BioFire COVID- March 23, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
19 Test (BioFire 2020 (/media/136356/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
Defense, LLC) (PDF, 317 KB) (/media/136357/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
123 KB)
Package Insert
3.44 MB)
Accula SARS- March 23, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
Cov-2 Test 2020 (/media/136345/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
(Mesa Biotech (PDF, 322 KB) (/media/136347/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Inc.) 135 KB) Authorizations Pursuant to 4, 2020)
(/media/136349) (PDF, 123 KB) 159 KB) (February 4, 2020)
Package Insert
2.29 MB)
Federal
In Vitro Register
PerkinElmer New March 24, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
Coronavirus 2020 (/media/136407/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
Nucleic Acid (PDF, 319 KB) (/media/136408/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Detection Kit 133 KB) Authorizations Pursuant to 4, 2020)
(PerkinElmer, Letter Granting EUA Section 564(b) of the FD&C Act
Inc.) Amendment(s) (April 1, 2020) Fact Sheet for Patients (/media/135010/download)(PDF,
(PDF, 136 KB) 121 KB)
Package Insert
374 KB)
AvellinoCoV2 March 25, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
test (Avellino 2020 (/media/136450/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
Lab USA, Inc.) (PDF, 284 KB) (/media/136451/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
120 KB)
EUA Summary
135 KB)
Real-Time March 26, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
Fluorescent RT- 2020 (/media/136473/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
PCR Kit for (PDF, 131 KB) (/media/136471/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Detecting SARS- 163 KB) Authorizations Pursuant to 4, 2020)
2019-nCoV (BGI Section 564(b) of the FD&C Act
Genomics Co. Fact Sheet for Patients (/media/135010/download)(PDF,
Ltd) (/media/136474/download) (PDF, 159 KB) (February 4, 2020)
151 KB)
Package Insert
1.07 MB)
Federal
In Vitro Register
ID NOW COVID- March 27, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
19 (Abbott 2020 (/media/136522/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
Diagnostics (PDF, 356 KB) (/media/136523/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Scarborough, 137 KB) Authorizations Pursuant to 4, 2020)
Inc.) Section 564(b) of the FD&C Act
124 KB)
Package Insert
2.95 MB)
NxTAG CoV March 27, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
Extended Panel 2020 (/media/136497/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
Assay (Luminex (PDF, 318 KB) (/media/136498/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Molecular 136 KB) Authorizations Pursuant to 4, 2020)
Diagnostics, Inc. Section 564(b) of the FD&C Act
Luminex Fact Sheet for Patients (/media/135010/download)(PDF,
Molecular (/media/136499/download) (PDF, 159 KB) (February 4, 2020)
Diagnostics, 123 KB)
Inc.)
Package Insert
768 KB)
NeuMoDx SARS- March 30, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
CoV-2 Assay 2020 (/media/136566/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
(NeuMoDx (PDF, 127 KB) (/media/136564/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Molecular, Inc.) 135 KB) Authorizations Pursuant to 4, 2020)
124 KB)
Package Insert
441 KB)
Federal
In Vitro Register
QIAstat-Dx March 30, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
Respiratory 2020 (/media/136569/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
SARS-CoV-2 (PDF, 128 KB) (/media/136568/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Panel (QIAGEN 140 KB) Authorizations Pursuant to 4, 2020)
GmbH) Section 564(b) of the FD&C Act
124 KB)
Package Insert
1.81 MB)
Cellex Inc. April 1, 2020 Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
qSARS-CoV-2 (/media/136622/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
IgG/IgM Rapid (PDF, 328 KB) (/media/136623/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Test (Cellex Inc.) 136 KB) Authorizations Pursuant to 4, 2020)
123 KB)
Package Insert
319 KB)
COV-19 IDx April 1, 2020 Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
assay (Ipsum (/media/136618/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
Diagnostics, (PDF, 288 KB) (/media/136619/download) (PDF, Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
LLC) 133 KB) Authorizations Pursuant to 4, 2020)
121 KB)
EUA Summary
130 KB)
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.
EUA Letter of Authorization - Laboratories Who Have Developed a Molecular-Based Test (LDTs) for Coronavirus Disease 2019 (COVID-19) (/media/136598/download) (PDF, 144
KB)
Fact Sheet for Healthcare Providers (/media/136599/download) (PDF, 134 KB)
Fact Sheet for Patients (/media/136600/download) (PDF, 123 KB)

See the table below for a current list of included laboratories and their LDTs
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, March 31, 2020 Letter Granting Inclusion EUA Summary (/media/136602/download)
Clinical Virology Laboratory (/media/136601/download) (PDF, 72 KB) (PDF, 121 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 (/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-
products/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 (/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-increase-us-supplies-through-instructions-ppe-and).
For more information on the Emergency Use Authorizations listed below (https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-
authorizations#coronavirus2019), see Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.
Federal
Personal Register
Protective Date of EUA Notice for Information for Manufacturers EUA Determination and
Equipment Issuance Letter of Authorization EUA and Strategic Stockpilers Declaration (Effective Date) PREP Act Declaration (if applicable)
NIOSH-Approved March 2, 2020 Letter of Authorization Manufacturers of authorized Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
Air Purifying (/media/135763/download) respirators do not need to Emergency and Declaration that for medical countermeasures against COVID-19
Respirators for Use March 27, (PDF, 232 KB) submit attestation to the FDA Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
in Health Care 2020 to request authorization. Authorizations Pursuant to 4, 2020)
Settings During (reissuance) EUA Clari cation Letter on Section 564(b) of the FD&C Act
Response to the Respirators Strategic stockpilers of (/media/135010/download)(PDF,
COVID-19 Public March 28, (/media/136023/download)(PDF, authorized expired ltering 159 KB) (February 4, 2020)
Health Emergency 2020 49 KB) facepiece respirators (FFRs) do
(reissuance) not need to submit a request to Declaration that Circumstances
the FDA to request Exist Justifying Authorizations
authorization. Pursuant to Section 564 of the
Federal Food, Drug, and
Cosmetic Act
(/media/135787/download)(PDF,
42 KB) (March 2, 2020)
Federal
Personal Register
Protective Date of EUA Notice for Information for Manufacturers EUA Determination and
Equipment Issuance Letter of Authorization EUA and Strategic Stockpilers Declaration (Effective Date) PREP Act Declaration (if applicable)
Imported, Non- March 24, Letter of Authorization Non-NIOSH Approved Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
NIOSH-Approved 2020 (/media/136403/download) Respirator EUA FAQ (/medical- Emergency and Declaration that for medical countermeasures against COVID-19
Disposable Filtering (PDF, 208 KB) devices/emergency-situations- Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
Facepiece March 28, medical-devices/non-niosh- Authorizations Pursuant to 4, 2020)
Respirators 2020 approved-respirator-eua-faq) Section 564(b) of the FD&C Act
(reissuance) (/media/135010/download)(PDF,
159 KB) (February 4, 2020)
Declaration that Circumstances

Exist Justifying Authorizations
Pursuant to Section 564 of the
Federal Food, Drug, and
Cosmetic Act
42 KB) (March 2, 2020)
Battelle March 28, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Health Notice of Declaration under the Public Readiness and Emergency Preparedness Act
Decontamination 2020 (/media/136529/download) Providers Emergency and Declaration that for medical countermeasures against COVID-19
System (PDF, 151 KB) (/media/136530/download) Circumstances Exist Justifying (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
March 29, (PDF, 273 KB) Authorizations Pursuant to 4, 2020)
2020 Section 564(b) of the FD&C Act
(reissuance) Instructions for Healthcare (/media/135010/download)(PDF,
Facilities 159 KB) (February 4, 2020)
(/media/136531/download)
(PDF, 212 KB) Declaration that Circumstances
Exist Justifying Authorizations
Instructions for Healthcare Pursuant to Section 564 of the
Personnel Federal Food, Drug, and
(/media/136532/download) Cosmetic Act
(PDF, 183 KB) (/media/135787/download)(PDF,
42 KB) (March 2, 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 (/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-

guidance-documents) for additional information..
For more information on the Emergency Use Authorizations listed below (/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations), see Coronavirus
Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.
Date of EUA Federal Register Fact Sheets and Manufacturer EUA Determination and
Medical Device Issuance Letter of Authorization Notice for EUA Instructions/ Package Insert Declaration (Effective Date) PREP Act Declaration (if applicable)
Date of EUA Federal Register Fact Sheets and Manufacturer EUA Determination and
Medical Device Issuance Letter of Authorization Notice for EUA Instructions/ Package Insert Declaration (Effective Date) PREP Act Declaration (if applicable)
Ventilators, March 24, Letter of Authorization Fact Sheet for Healthcare Determination of a Public Notice of Declaration under the Public Readiness and Emergency Preparedness Act
anesthesia gas 2020 (/media/136423/download) Providers Health Emergency and for medical countermeasures against COVID-19
machines modi ed (PDF, 359 KB) (/media/136424/download) (PDF, Declaration that (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
for use as 133 KB) Circumstances Exist 4, 2020)
ventilators, and Appendix A: Criteria for Justifying Authorizations
positive pressure Safety, Performance and Fact Sheet for Patients Pursuant to Section 564(b) of
breathing devices Labeling (/media/136425/download) (PDF, the FD&C Act
modi ed for use as (/media/136437/download) 126 KB) (/media/136421/download)
ventilators (PDF, 214 KB) (PDF, 147 KB) (March 24,
(collectively 2020)
referred to as Appendix B: Authorized
"ventilators"), Ventilators, Ventilator Tubing A agencia nacional de saúde dos EUA aprova em carater emergencial e da todo
ventilator tubing Connectors, and Ventilator caminho para adaptar ventiladores usados para anestesias cirurgicas,
connectors, and Accessories equipamentos de pressão positiva para somar aos ventiladores de respiração
ventilator (/media/136528/download) caros e convencionais.
accessories (PDF, 129 KB)
Therapeutics
On March 28, 2020, FDA issued an EUA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile
(https://www.phe.gov/about/sns/Pages/default.aspx) (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. De 28 de março até o presente momento no mundo é o único protocolo terapeutico aprovado em carater de emergencia para combate da doença. As seções acima não
trabalham o combate direto da doença. Acima há apenas liberaçoes de dos Kits de Teste para doença, dos EPIs que protegem e dos equipamentos (ventiladores etc..)
para dar apenas suporte de vida. Nada disso cura ou diminui a infecção!!! Apenas o protocolo (Therapeutics) citado nessa seção.
Federal
Date of EUA Register Notice Fact Sheets and Manufacturer EUA Determination and
Therapeutic Product Issuance Letter of Authorization for EUA Instructions/ Package Insert Declaration (Effective Date) PREP Act Declaration (if applicable)
Chloroquine phosphate March 28, Letter of Authorization Chloroquine Phosphate Fact Declaration That Notice of Declaration under the Public Readiness and Emergency Preparedness Act
and 2020 (/media/136534/download) Sheet for Healthcare Providers Circumstances Exist for medical countermeasures against COVID-19
hydroxychloroquine (PDF, 229 KB) (/media/136535/download) (PDF, Justifying Authorizations (https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx)(February
sulfate for treatment of 217 KB) Pursuant to Section 564 of 4, 2020)
COVID-19 the FD&C Act
Chloroquine Phosphate Fact (/media/136539/download)
Sheet for Patients (PDF, 119 KB) (March 27,
Declaração Emergencial Americana para
A Carta de Autorização do uso controlado (/media/136536/download) (PDF, 2020) emprego de Tratamentos em Protocolos
da Cloroquina vem com todo esclarecimento 147 KB) Emergenciais.
relacionado a:
- Defesa da emergencia e o porque não da Hydroxychloroquine Sulfate Fact Aqui no Brasil é como se fosse um Decreto
tempo de espera do estudo profundo dos Sheet for Healthcare Providers Executivo do Ministro da Saúde dando
casos clinicos, que convencionalmente (/media/136537/download) (PDF, poderes para se usar procedimento, isentando
duram 2 anos. 206 KB) de punição e processos, fabricantes,
- Determina exatamente o protocolo de uso distribuidores, hospitais e médicos em caso de
Hydroxychloroquine Sulfate Fact morte do paciente.
das drogas em hospitais e em condições
Sheet for Patients
bem especificas (leiam a carta de 8 paginas
de autorização em anexo caso queiram a 148 KB)
verdade.
Ebola Virus EUA Information
Ebola preparedness and response updates from FDA (/emergency-preparedness-and-response/mcm-issues/ebola-preparedness-and-response-updates-

fda) (all agency activities)
For more information about the diagnostics below, also see Emergency Use Authorizations (/medical-devices/emergency-situations-medical-devices/emergency-use-
authorizations) (current device EUAs).
Ebola Diagnostic Tests with De Novo, 510(k) or PMA

OraQuickEbola Rapid Antigen Test (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm?ID=DEN190025)- On October 10, 2019, FDA allowed marketing
(https://www.accessdata.fda.gov/cdrh_docs/pdf19/DEN190025.pdf) (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 uid). The OraQuick Ebola Rapid Antigen Test is the rst 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 con rmed. Also see the FDA news release: FDA allows marketing of rst
rapid diagnostic test for detecting Ebola virus antigens (/news-events/press-announcements/fda-allows-marketing- rst-rapid-diagnostic-test-detecting-ebola-virus-antigens)
The OraQuick Ebola Test was reviewed under the De Novo premarket review pathway (/medical-devices/premarket-submissions/de-novo-classi cation-request), 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 classi cation, 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 Date of EUA Issuance Letter of Authorization Federal Register Notice for EUA Fact Sheets and Manufacturer EUA Determination and Declaration (Effective Date) PREP Act
Product Instructions/Package Insert Declarati
(if
applicabl
EZ1 Real-time August 5, 2014 (initial Authorization FR notice Healthcare Declaration Regarding Emergency Use of In Vitro
RT-PCR Assay issuance) (/media/89984/download) (https://www.federalregister.gov/articles/2014/09/17/2014- (/media/89986/download) (PDF, 58 Diagnostics for Detection of Ebola Virus
(DoD) (PDF, 61 KB) 22086/authorization-of-emergency-use-of-an-in-vitro- KB) (https://www.federalregister.gov/articles/2014/08/12/2014-
October 10, 2014
diagnostic-device-for-detection-of-ebola-zaire-virus) 19026/declaration-regarding-emergency-use-of-in-vitro-
(reissuance) Patients (/media/89988/download)
diagnostics-for-detection-of-ebola-virus) (August 4, 2014)
(PDF, 59 KB)

Instruction Booklet
(/media/89989/download) (PDF, 1.1
MB)
CDC Ebola October 10, Authorization FR notice Healthcare Declaration Regarding Emergency Use of In Vitro
Virus NP Real- 2014 (initial issuance) (/media/91083/download) (https://www.federalregister.gov/articles/2014/12/24/2014- (/media/91087/download) (PDF, 207 Diagnostics for Detection of Ebola Virus
time RT-PCR (PDF, 282 KB) 30108/authorizations-of-emergency-use-of-in-vitro-diagnostic- KB) (https://www.federalregister.gov/articles/2014/08/12/2014-
March 2, 2015
Assay devices-for-detection-of-ebola-zaire-virus) 19026/declaration-regarding-emergency-use-of-in-vitro-
(reissuance) Letter granting EUA Patients (/media/91092/download)
(CDC) diagnostics-for-detection-of-ebola-virus) (August 4, 2014)
amendment(s) (PDF, 134 (PDF, 149 KB)
October 8, 2019
KB)
(amended) Instructions for Use
(/media/91097/download) (PDF, 496

KB)
CDC Ebola October 10, Authorization FR notice Healthcare Declaration Regarding Emergency Use of In Vitro
Virus VP40 2014 (initial issuance) (/media/91105/download) (https://www.federalregister.gov/articles/2014/12/24/2014- (/media/91111/download) (PDF, 207 Diagnostics for Detection of Ebola Virus
Real-time RT- (PDF, 285 KB) 30108/authorizations-of-emergency-use-of-in-vitro-diagnostic- KB) (https://www.federalregister.gov/articles/2014/08/12/2014-
March 2, 2015
PCR Assay devices-for-detection-of-ebola-zaire-virus) 19026/declaration-regarding-emergency-use-of-in-vitro-
(reissuance) Letter granting EUA Patients (/media/91118/download)
(CDC) diagnostics-for-detection-of-ebola-virus) (August 4, 2014)
October 8, 2019
KB)
(amended) Instructions for Use

KB)
FilmArray October 25, Authorization FR notice Healthcare Declaration Regarding Emergency Use of In Vitro
NGDS BT-E 2014 (initial issuance) (/media/91070/download) (https://www.federalregister.gov/articles/2015/02/09/2015- (/media/91149/download) (PDF, 40 Diagnostics for Detection of Ebola Virus
Assay (PDF, 326 KB) 02467/authorizations-of-emergency-use-of-in-vitro-diagnostic- KB) (https://www.federalregister.gov/articles/2014/08/12/2014-
March 2, 2015
(Bio re devices-for-detection-of-ebola-virus) 19026/declaration-regarding-emergency-use-of-in-vitro-
Defense, LLC) diagnostics-for-detection-of-ebola-virus) (August 4, 2014)
(PDF, 40 KB)

KB)
FilmArray October 25, 2014 Authorization FR notice Healthcare Declaration Regarding Emergency Use of In Vitro
Biothreat-E (/media/89580/download) (https://www.federalregister.gov/articles/2015/02/09/2015- (/media/89585/download) (PDF, 227 Diagnostics for Detection of Ebola Virus
November 12, 2019
test (PDF, 73 KB) 02467/authorizations-of-emergency-use-of-in-vitro-diagnostic- KB) (https://www.federalregister.gov/articles/2014/08/12/2014-
(amended)
(Bio re devices-for-detection-of-ebola-virus) 19026/declaration-regarding-emergency-use-of-in-vitro-
Letter granting EUA Patients (/media/89604/download)
Defense, LLC) diagnostics-for-detection-of-ebola-virus) (August 4, 2014)
KB)
MB)
RealStar November 10, Authorization FR notice Healthcare Declaration Regarding Emergency Use of In Vitro
Ebolavirus RT- 2014 (initial issuance) (/media/123410/download) (https://www.federalregister.gov/articles/2015/02/09/2015- (/media/120428/download) (PDF, 81 Diagnostics for Detection of Ebola Virus
PCR Kit 1.0 (PDF, 263 KB) 02467/authorizations-of-emergency-use-of-in-vitro-diagnostic- KB) (https://www.federalregister.gov/articles/2014/08/12/2014-
November 26, 2014
(altona devices-for-detection-of-ebola-virus) 19026/declaration-regarding-emergency-use-of-in-vitro-
Diagnostics, diagnostics-for-detection-of-ebola-virus) (August 4, 2014)
(PDF, 92 KB)
GmbH)
KB)
LightMix December 23, 2014 Authorization FR notice Healthcare Declaration Regarding Emergency Use of In Vitro
Ebola Zaire (/media/120431/download) (https://www.federalregister.gov/articles/2015/03/17/2015- (/media/120432/download) (PDF, 59 Diagnostics for Detection of Ebola Virus
rRT-PCR Test (PDF, 2.2 MB) 06039/authorization-of-emergency-use-of-an-in-vitro- KB) (https://www.federalregister.gov/articles/2014/08/12/2014-
(Roche diagnostic-device-for-detection-of-ebola-zaire-virus) 19026/declaration-regarding-emergency-use-of-in-vitro-
Patients (/media/120433/download)
Molecular diagnostics-for-detection-of-ebola-virus) (August 4, 2014)
(PDF, 60 KB)
Systems, Inc.)
(/system/404) (PDF, 328 KB)
Xpert Ebola March 23, 2015 Authorization FR notice Healthcare Declaration Regarding Emergency Use of In Vitro
Assay (/media/91315/download) (https://www.federalregister.gov/articles/2015/06/05/2015- (/media/91934/download) (PDF, 310 Diagnostics for Detection of Ebola Virus
(Cepheid) (PDF, 240 KB) 13699/authorizations-of-emergency-use-of-in-vitro-diagnostic- KB) (https://www.federalregister.gov/articles/2014/08/12/2014-
devices-for-detection-of-ebola-virus) 19026/declaration-regarding-emergency-use-of-in-vitro-
(PDF, 211 KB)

KB)
Idylla Ebola May 26, 2016 Authorization FR notice Healthcare Declaration Regarding Emergency Use of In Vitro
Virus Triage (/media/98460/download) (https://www.federalregister.gov/articles/2016/07/08/2016- (/media/98451/download)(PDF, 203 Diagnostics for Detection of Ebola Virus
Test (Biocartis (PDF, 321 KB) 16176/authorizations-of-emergency-use-in-vitro-diagnostic- KB) (https://www.federalregister.gov/articles/2014/08/12/2014-
NV) device-for-detection-of-ebola-zaire-virus) 19026/declaration-regarding-emergency-use-of-in-vitro-
Patients
KB)

MB)
DPP Ebola November 9, 2018 Authorization FR notice Healthcare Declaration Regarding Emergency Use of In Vitro
Antigen (/media/117735/download) (https://www.federalregister.gov/documents/2019/02/13/2019- (/media/117736/download)(PDF, 122 Diagnostics for Detection of Ebola Virus
April 2, 2019
System (PDF, 103 KB) 02134/authorization-of-emergency-use-of-an-in-vitro- KB) (https://www.federalregister.gov/articles/2014/08/12/2014-
(amended)
(Chembio diagnostic-device-for-detection-of-ebola-virus) 19026/declaration-regarding-emergency-use-of-in-vitro-
Letter Granting EUA Patients (/media/117737/download)
Diagnostic diagnostics-for-detection-of-ebola-virus) (August 4, 2014)
Amendment(s) (PDF, 119 KB)
Systems, Inc.)
(PDF, 87 KB)
MB)
Enterovirus D68 (EV-D68) EUA Information

Medical Date of Letter of Authorization Federal Register Notice for EUA Fact Sheets and Manufacturer EUA Determination and Declaration (Effective Date) PREP Act
Product EUA Instructions/Package Insert Declaration
Issuance (if
applicable)
CDC May 12, Authorization FR notice Healthcare Determination and Declaration Regarding Emergency Use of
Enterovirus 2015 (/media/120425/download) (https://www.federalregister.gov/articles/2015/07/01/2015- (/media/92008/download) New In Vitro Diagnostics for Detection of Enterovirus D68
D68 2014 (PDF, 229 KB) 16125/authorization-of-emergency-use-of-an-in-vitro- (PDF, 214 KB) (https://www.federalregister.gov/articles/2015/02/27/2015-
Real-time diagnostic-device-for-detection-of-enterovirus-d68) 04121/determination-and-declaration-regarding-emergency-
Patients
RT-PCR use-of-new-in-vitro-diagnostics-for-detection-of) (February 6,
Assay (EV- 2015)
(PDF, 150 KB)
D68 2014
rRT-PCR) Instructions for Use
531 KB)
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 (/news-events/press-announcements/fda-takes-action-support-american-military-personnel-granting-authorization-freeze-dried-plasma) (July 10,
2018)
Medical Date of Letter of Authorization Federal Register Notice for EUA Fact Sheets and Manufacturer EUA Determination and Declaration (Effective Date) PREP Act
Product EUA Instructions/Package Insert Declaration
Issuance (if
applicable)
Pathogen- July 9, Authorization FR notice Fact Sheet for U.S. Military Determination by DoD (June 7, 2018)
Reduced 2018 (/media/114282/download) (https://www.federalregister.gov/documents/2018/08/13/2018- Medical Personnel
Declaration Regarding Emergency Use of Treatment for
Leukocyte- (PDF, 203 KB) 17303/authorization-of-emergency-use-of-a-freeze-dried- (/media/119949/download)
Hemorrhage or Coagulopathy During an Emergency Involving
Depleted plasma-treatment-for-hemorrhage-or-coagulopathy) (PDF, 140 KB)
Agents of Military Combat
Freeze
Fact Sheet for Recipients (https://www.federalregister.gov/documents/2018/07/31/2018-
Dried
(/media/119948/download) 16331/emergency-use-of-treatment-for-uncontrolled-
Plasma
(PDF, 74 KB) hemorrhage-due-to-agents-of-military-combat-correction) (July
(Centre de
9, 2018)
Transfusion
Sanguine
des
Armées)
H7N9 Influenza EUA Information
Medical Date of EUA Letter of Authorization Federal Register Notice for EUA Fact Sheet and Manufacturer EUA Determination and Declaration (Effective Date) PREP Act Declaration (if ap
Product Issuance Instructions/Package Insert
CDC April 22, Authorization FR notice Healthcare Determination and Declaration Regarding Emergency Use of in Vitro Pandemic In uenza Medica
Human 2013 (initial (/media/85910/download) (https://www.federalregister.gov/articles/2013/06/25/2013- (/media/85915/download) Diagnostics for Detection of the Avian In uenza A (H7N9) Virus (https://www.federalregister
In uenza issuance) (PDF, 301 KB), re-issued 15096/authorization-of-emergency-use-of-an-in-vitro- (PDF, 46 KB) (https://www.federalregister.gov/articles/2013/04/30/2013- 31087/pandemic-in uenza-m
Virus Real- March 27, 2018 diagnostic-for-detection-of-the-novel-avian-in uenza) 10055/determination-and-declaration-regarding-emergency-use-of-in- amendment)(The amendme
Patients
Time RT- vitro-diagnostics-for-detection-of-the) (April 19, 2013) declaration as amended Jun
PCR March 27, 2008, declaration and Febru
(PDF, 32 KB) Additional information from HHS
Diagnostic 2018 effective as of January 1, 20
(http://www.phe.gov/emergency/news/healthactions/phe/Pages/H7N9-
Panel- (reissuance) Instructions for Use
in uenza-virus.aspx)
In uenza (/media/85454/download)
A/H7 (PDF, 433 KB)
(Eurasian
Lineage)
Assay

Quidel February 14, Authorization FR notice Healthcare Determination and Declaration Regarding Emergency Use of in Vitro Pandemic In uenza Medica
Lyra 2014 (/media/87767/download) (https://www.federalregister.gov/articles/2014/04/17/2014- (/media/87775/download) Diagnostics for Detection of the Avian In uenza A (H7N9) Virus (https://www.federalregister
In uenza (PDF, 57 KB) 08706/authorization-of-emergency-use-of-an-in-vitro- (PDF, 42 KB) (https://www.federalregister.gov/articles/2013/04/30/2013- 31087/pandemic-in uenza-m
A Subtype diagnostic-device-for-detection-of-novel-in uenza-a) 10055/determination-and-declaration-regarding-emergency-use-of-in- amendment)(The amendme
Patients
H7N9 vitro-diagnostics-for-detection-of-the) (April 19, 2013) declaration as amended Jun
Assay 2008, declaration and Febru
(PDF, 40 KB) Additional information from HHS
effective as of January 1, 20
A/H7N9 April 25, Authorization (/medical- FR notice Healthcare (/medical- Determination and Declaration Regarding Emergency Use of in Vitro Pandemic In uenza Medica
In uenza 2014 devices/emergency- (https://www.federalregister.gov/articles/2014/06/23/2014- devices/emergency- Diagnostics for Detection of the Avian In uenza A (H7N9) Virus (https://www.federalregister
Rapid Test situations-medical- 14547/authorization-of-emergency-use-of-an-in-vitro- situations-medical- (https://www.federalregister.gov/articles/2013/04/30/2013- 31087/pandemic-in uenza-m
devices/ah7n9-in uenza- diagnostic-device-for-detection-of-novel-in uenza-a) devices/fact-sheet-health- 10055/determination-and-declaration-regarding-emergency-use-of-in- amendment)(The amendme
rapid-test-letter- care-providers- vitro-diagnostics-for-detection-of-the) (April 19, 2013) declaration as amended Jun
authorization) interpreting-ah7n9- 2008, declaration and Febru
Additional information from HHS
in uenza-rapid-test- effective as of January 1, 20
results)
Patients (/medical-
devices/emergency-
situations-medical-
devices/fact-sheet-
patients-understanding-
results-ah7n9-in uenza-
rapid-test)
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information

Medical Date of EUA Letter of Authorization Federal Register Notice for EUA Fact Sheets and Manufacturer EUA Determination and Declaration (Effective Date) PREP Act
Product Issuance Instructions/Package Insert Declaration
(if
applicable)
CDC Novel June 5, Authorization FR notice Healthcare (/medical- Determination and Declaration Regarding Emergency Use of In Vitro
Coronavirus 2013 (initial (/media/88518/download) (https://www.federalregister.gov/documents/2013/07/17/2013- devices/emergency-situations- Diagnostics for Detection of Middle East Respiratory Syndrome
2012 Real- issuance) (PDF, 2.2 MB) 17103/authorization-of-emergency-use-of-an-in-vitro- medical-devices/fact-sheet- Coronavirus (MERS-CoV)
time RT-PCR diagnostic-for-detection-of-middle-east-respiratory) health-care-professionals- (https://www.federalregister.gov/articles/2013/06/05/2013-
June 10,
Assay interpreting-cdc-novel- 13333/determination-and-declaration-regarding-emergency-use-of-in-
2014
coronavirus-2012-real-time-rt-pcr- vitro-diagnostics-for-detection-of) (May 29, 2013)
(reissuance)
assay)
Additional information from HHS

Patients (/medical- (http://www.phe.gov/emergency/news/healthactions/phe/Pages/mers-
devices/emergency-situations- cov.aspx)
medical-devices/fact-sheet-
patients-understanding-results-
cdc-novel-coronavirus-2012-real-
time-rt-pcr-assay)
Contacts
1.2 MB)

743 KB)
RealStar July 17, Authorization FR notice Healthcare Determination and Declaration Regarding Emergency Use of In Vitro
MERS-CoV 2015 (/media/93040/download) (https://www.federalregister.gov/documents/2015/09/01/2015- (/media/93048/download) (PDF, Diagnostics for Detection of Middle East Respiratory Syndrome
RT-PCR Kit (initial (PDF, 238 KB) 21585/authorization-of-emergency-use-of-an-in-vitro- 269 KB) Coronavirus (MERS-CoV)
U.S. issuance) diagnostic-device-for-detection-of-middle-east) (https://www.federalregister.gov/articles/2013/06/05/2013-
Patients
13333/determination-and-declaration-regarding-emergency-use-of-in-
February 12, (/media/93056/download) (PDF,
vitro-diagnostics-for-detection-of) (May 29, 2013)
2016 241 KB)
(reissuance) Additional information from HHS
(http://www.phe.gov/emergency/news/healthactions/phe/Pages/mers-
cov.aspx)
840 KB)

Fact Sheet for Asymptomatic
Individuals Suspected of
Exposure to MERS-CoV Cases
285 KB)
Nerve Agent EUA Information

On July 9, 2018, FDA approved (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/212319Orig1s000ltr.pdf) (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 (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/212319s000lbl.pdf) (PDF, 482 KB). The EUA detailed in the table below is still in effect.
Medical Date of Letter of Authorization Federal Register Notice for EUA Fact Sheets and Manufacturer EUA Determination and Declaration (Effective Date) PREP Act Declaration (if appl
Product EUA Instructions/Package Insert
Issuance
Atropine April 11, Letter of Authorization FR Healthcare Determination and Declaration Regarding Nerve Agent or Nerve Agents and Certain Inse
Auto- 2017 (/media/104550/download) notice (/media/104559/download) Certain Insecticide (Organophosphorus and/or Carbamate) and/or Carbamate) Counterm
Injector (initial (PDF, 514 KB) (https://www.federalregister.gov/documents/2017/06/30/2017- (PDF, 531 KB) Poisoning (https://www.federalregister.g
(Rafa issuance) 13664/emergency-use-authorizations-injectable-treatment-for- (https://www.federalregister.gov/documents/2017/04/17/2017- 09455/nerve-agents-and-certa
Letter granting EUA Patients and Caregivers
Laboratories nerve-agent-or-certain-insecticide) 07685/determination-and-declaration-regarding-emergency-use- organophosphorus-andor-carb
May 23, amendment(s) (/media/104564/download)
Ltd.) of-injectable-treatments-for-nerve-agent-or) (April 11, 2017) 11, 2017)
2017 (/media/105590/download) (PDF, 675 KB)
(amended) (PDF, 28 KB)
January 2nd letter granting EUA

24, 2018 amendment(s)
(amended) (/media/110881/download)
(PDF, 33 KB)
March 6,
2018 3rd letter granting EUA
(amended) amendment(s)
May 15,
(PDF, 85 KB)
2018
(amended) 4th letter granting EUA
amendment(s)
(PDF, 42 KB)
Zika Virus EUA Information
Zika virus response updates from FDA (/emergency-preparedness-and-response/mcm-issues/zika-virus-response-updates-fda)
Zika virus diagnostic development information (/emergency-preparedness-and-response/mcm-issues/zika-virus-diagnostic-development)
For more information about the diagnostics below, also see Emergency Use Authorizations (/medical-devices/emergency-situations-medical-
devices/emergency-use-authorizations) (current device EUAs).
Draft EUA review templates for Zika are available by email request to: CDRH-ZIKA-Templates@fda.hhs.gov (mailto:CDRH-ZIKA-Templates@fda.hhs.gov?Subject=EUA template
request)
Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov (mailto: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 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm?ID=DEN180069) - On May 23, 2019, FDA authorized marketing
(https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180069.pdf) (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 rst 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 rst diagnostic test for detecting Zika virus
antibodies (/news-events/press-announcements/fda-authorizes-marketing- rst-diagnostic-test-detecting-zika-virus-antibodies)
ADVIA Centaur Zika test (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191578) – 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 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192046) – 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 Letters Federal Register Notice for EUA Fact Sheets and Manufacturer EUA Determination and Declaratio
Issuance Instructions/Package Insert
CDC Zika Immunoglobulin M (IgM) Antibody February 26, Letter granting EUA amendment(s) FR notice Healthcare Emergency Use of In Vitro Diagnos
Capture Enzyme-Linked Immunosorbent Assay 2016 (initial (/media/101616/download) (PDF, 155 (https://www.federalregister.gov/articles/2016/03/28/2016- (/media/96355/download) (PDF, 83 Zika Virus and/or Diagnosis of Zik
issuance) KB) 06888/authorization-of-emergency-use-of-an-in-vitro- KB) (https://www.federalregister.gov/a
CDC statement on this EUA
diagnostic-device-for-diagnosis-of-zika-virus) 04624/emergency-use-of-in-vitro-d
(http://www.cdc.gov/media/releases/2016/s0226- June 29, Letter granting EUA amendment(s) Patients (/media/120190/download)
detection-of-zika-virus-andor-diagn
laboratory-test-for-zika-virus.html) 2016 (amended) (/media/101586/download) (PDF, 123 (PDF, 220 KB)
(February 26, 2016)
KB)
November 15, Instructions for Use
2016 (amended) Letter granting EUA amendment(s) (/media/96373/download) (PDF, 5.5
(/media/120186/download) MB)
December 6,
(PDF, 110 KB)
2016 (amended)
Letter granting EUA amendment(s)
May 3, 2017
(amended)
KB)
July 31, 2017
(amended)
April 16, 2018 KB)
(amended)
September 26, (/media/120189/download) (PDF, 131
2018 (amended) KB)
CDC Trioplex Real-time RT-PCR Assay (Trioplex March 17, 2016 Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
rRT-PCR) (initial (/media/96683/download) (PDF, 82 (https://www.federalregister.gov/articles/2016/04/22/2016- (/media/120193/download)(PDF, 224 Zika Virus and/or Diagnosis of Zik
issuance) KB) 09370/authorization-of-emergency-use-of-an-in-vitro- KB) (https://www.federalregister.gov/a
CDC statement on this EUA
diagnostic-device-for-detection-of-zika-virus) 04624/emergency-use-of-in-vitro-d
(http://www.cdc.gov/media/releases/2016/s0318- September 21, Letter granting EUA amendment(s) Patients (/media/120194/download)
zika-lab-test.html) 2016 (amended) (/media/100200/download) (PDF, 223 (PDF, 200 KB)
(February 26, 2016)
KB)
January 12, Instructions for Use
2017 (amended) Letter granting EUA amendment(s) (/media/123606/download) (PDF, 4
(/media/102439/download) (PDF, 223 MB)
February 28,
KB)
2017 (amended)
April 6,
2017 (amended)
KB)

KB)
Zika Virus RNA Qualitative Real-Time RT-PCR April 28, 2016 Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
(Quest Diagnostics Infectious Disease, Inc.) (initial (/media/122435/download) (https://www.federalregister.gov/articles/2016/06/17/2016- (/media/120128/download) (PDF, 53 Zika Virus and/or Diagnosis of Zik
issuance) (PDF, 339 KB) 14380/authorizations-of-emergency-use-of-in-vitro-diagnostic- KB) (https://www.federalregister.gov/a
devices-for-detection-of-zika-virus) 04624/emergency-use-of-in-vitro-d
October 7, 2016 Letter granting EUA amendment(s) Patients (/media/120129/download)
(reissuance) (/media/120127/download) (PDF, 126 (PDF, 27 KB)
(February 26, 2016)
KB)
April 11, 2017 Instructions for Use
(amended) (/media/120130/download)
(/media/97712/download)(PDF, 439
KB)
RealStar Zika Virus RT-PCR Kit U.S. (altona May 13, 2016 Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
Diagnostics GmbH) (initial (/media/120121/download) (PDF, 342 (https://www.federalregister.gov/articles/2016/06/17/2016- (/media/120124/download) Zika Virus and/or Diagnosis of Zik
issuance) KB) 14380/authorizations-of-emergency-use-of-in-vitro-diagnostic- (/media/90487/download)(PDF, 232 (https://www.federalregister.gov/a
devices-for-detection-of-zika-virus) KB) 04624/emergency-use-of-in-vitro-d
October 31, Letter Granting EUA Amendment(s)
2016 (amended) (/media/120122/download) (PDF, 130 Patients (/media/120125/download)
(February 26, 2016)
KB) (PDF, 213 KB)
March 6, 2017
(amended) Letter Granting EUA Amendment(s) Instructions for Use
(/media/120123/download) (PDF, 130 (/media/120126/download)(PDF, 972
KB) KB)
Aptima Zika Virus assay (Hologic, Inc.) June 17, 2016 Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
(initial (/media/120114/download) (PDF, 305 (https://www.federalregister.gov/articles/2016/07/08/2016- (/media/120118/download) Zika Virus and/or Diagnosis of Zik
issuance) KB) 16177/authorizations-of-emergency-use-in-vitro-diagnostic- (PDF, 208 KB) (https://www.federalregister.gov/a
device-for-detection-of-zika-virus) 04624/emergency-use-of-in-vitro-d
September 7, Letter granting EUA amendment(s) Patients (/media/120119/download)
2016 (amended) (/media/122434/download) (PDF, 126 (PDF, 190 KB)
(February 26, 2016)
KB)
April 12, 2017 Instructions for Use
(amended) Letter granting EUA amendment(s) (/media/120120/download)
(/media/120116/download)(PDF, (PDF, 276 KB)
March 8, 2018
124 KB)
(amended)

(/media/120117/download)(PDF, 130
KB)
Zika Virus Real-time RT-PCR Test (Viracor July 19, 2016 Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
Euro ns) (initial (/media/120033/download) (PDF, 334 (https://www.federalregister.gov/articles/2016/09/07/2016- (/media/120035/download) Zika Virus and/or Diagnosis of Zik
issuance) KB) 21353/authorization-of-emergency-use-of-an-in-vitro- (PDF, 229 KB) (https://www.federalregister.gov/a
diagnostic-device-for-detection-of-zika-virus#h-6) 04624/emergency-use-of-in-vitro-d
February 28, Letter granting EUA amendment(s) Patients (/media/120036/download)
(February 26, 2016)
KB)
(PDF, 623 KB)
VERSANT Zika RNA 1.0 Assay (kPCR) Kit July 29, 2016 Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
(Siemens Healthcare Diagnostics Inc.) (initial (/media/99444/download) (PDF, 78 (https://www.federalregister.gov/documents/2016/10/28/2016- (/media/120031/download)(PDF, 170 Zika Virus and/or Diagnosis of Zik
issuance) KB) 26066/emergency-use-authorizations-in-vitro-diagnostic- KB) (https://www.federalregister.gov/a
devices-for-detection-andor-diagnosis-of-zika-virus) 04624/emergency-use-of-in-vitro-d
December 19, Letter granting EUA amendment(s) Patients (/media/120032/download)
(February 26, 2016)
KB)
KB)
Sentosa SA ZIKV RT-PCR Test (Vela Diagnostics September 23, Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
USA, Inc.) 2016 (/media/120017/download) (https://www.federalregister.gov/documents/2016/11/03/2016- (/media/120018/download) Zika Virus and/or Diagnosis of Zik
(PDF, 355 KB) 26532/authorizations-of-emergency-use-of-in-vitro-diagnostic- (PDF, 270 KB) (https://www.federalregister.gov/a
(PDF, 236 KB)
(February 26, 2016)
MB)
Zika Virus Detection by RT-PCR Test (ARUP September 28, Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
Laboratories) 2016 (/media/120014/download) (PDF, 98 (https://www.federalregister.gov/documents/2016/11/03/2016- (/media/120015/download) (PDF, 52 Zika Virus and/or Diagnosis of Zik
KB) 26532/authorizations-of-emergency-use-of-in-vitro-diagnostic- KB) (https://www.federalregister.gov/a
(PDF, 200 KB)
(February 26, 2016)
(PDF, 505 KB)
Abbott RealTime ZIKA (Abbott Molecular Inc.) November 21, Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
2016 (initial (/media/101657/download) (PDF, 84 (https://www.federalregister.gov/documents/2016/12/20/2016- (/media/120011/download) (PDF, Zika Virus and/or Diagnosis of Zik
issuance) KB) 30532/authorization-of-emergency-use-of-an-in-vitro- 208 KB) (https://www.federalregister.gov/a
January 6, 2017 Letter granting EUA amendment(s) Patients (/media/120012/download)
(amended) (/media/120010/download) (PDF, 150 (PDF, 217 KB)
(February 26, 2016)
KB)
MB)
Zika ELITe MGB Kit U.S. (ELITechGroup Inc. December 9, Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
Molecular Diagnostics) 2016 (/media/119919/download) (PDF, 312 (https://www.federalregister.gov/documents/2017/01/09/2017- (/media/119920/download) (PDF, Zika Virus and/or Diagnosis of Zik
KB) 00084/authorization-of-emergency-use-of-an-in-vitro- 213 KB) (https://www.federalregister.gov/a
(PDF, 179 KB)
(February 26, 2016)
(PDF, 718 KB)
Gene-RADAR Zika Virus Test (Nanobiosym March 20, 2017 Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
Diagnostics, Inc.) (/media/119915/download)(PDF, 313 (https://www.federalregister.gov/documents/2017/06/30/2017- (/media/119916/download) (PDF, Zika Virus and/or Diagnosis of Zik
KB) 13720/emergency-use-authorizations-in-vitro-diagnostic- 267 KB) (https://www.federalregister.gov/a
(PDF, 240 KB)
(February 26, 2016)
(PDF, 338 KB)
TaqPath Zika Virus Kit (Thermo Fisher Scienti c) August 2, 2017 Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
(/media/119906/download)(PDF, 292 (https://www.federalregister.gov/documents/2017/10/26/2017- (/media/119907/download) (PDF, Zika Virus and/or Diagnosis of Zik
KB) 23224/authorizations-of-emergency-use-of-in-vitro-diagnostic- 252 KB) (https://www.federalregister.gov/a
(PDF, 180 KB)
(February 26, 2016)

(PDF, 756 KB)
CII-ArboViroPlex rRT-PCR Assay (Columbia August 11, 2017 Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos
University) (/media/107073/download) (PDF, 377 (https://www.federalregister.gov/documents/2017/10/26/2017- (/media/107081/download) (PDF, Zika Virus and/or Diagnosis of Zik
KB) 23224/authorizations-of-emergency-use-of-in-vitro-diagnostic- 229 KB) (https://www.federalregister.gov/a
(PDF, 176 KB)
(February 26, 2016)
(PDF, 657 KB)
September 27, Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos

DPP Zika IgM Assay System (Chembio Diagnostic 2017 (initial (/media/119895/download) (PDF, 424 (https://www.federalregister.gov/documents/2017/11/17/2017- (/media/119898/download) Zika Virus and/or Diagnosis of Zik
Systems, Inc.) issuance) KB) 25010/authorizations-of-emergency-use-of-in-vitro-diagnostic- (PDF, 204 KB) (https://www.federalregister.gov/a
February 6, Letter granting EUA amendment(s) Patients (/media/119899/download)
2018 (amended) (/media/119896/download)(PDF, 130 (PDF, 144 KB)
(February 26, 2016)
KB)
August 3, 2018 Instructions for Use
(amended) Letter granting EUA amendment(s) (/media/119900/download) (PDF, 7.0
(/media/119897/download)(PDF, 129 MB)
KB)
Related Links
Summary of Process for EUA Issuance (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/summary-process-eua-issuance)
Emergency Use Authorization--Archived Information (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-

information)
Emergency Dispensing Orders (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-dispensing-orders)
21st Century Cures Act: MCM-Related Cures Provisions (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-

cures-provisions)
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/pandemic-

and-all-hazards-preparedness-reauthorization-act-2013-pahpra)
Public Readiness and Emergency Preparedness (PREP) Act (https://www.phe.gov/preparedness/legal/prepact/pages/default.aspx)
HHS Public Health Emergency EUA Authorization Declarations (http://www.phe.gov/emergency/news/healthactions/Lists/EUA/AllItems.aspx)
Ebola Preparedness and Response Updates from FDA (/emergency-preparedness-and-response/mcm-issues/ebola-preparedness-and-response-updates-fda)

Zika Virus Response Updates from FDA (/emergency-preparedness-and-response/mcm-issues/zika-virus-response-updates-fda)
Emergency Use Authorizations (Medical Devices) (/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations)
Historical Information about Device Emergency Use Authorizations (/medical-devices/emergency-situations-medical-devices/historical-information-about-device-emergency-use-

authorizations)

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Emergency Use Authorization

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Printable PDF (288 KB) (/media/97321/download)

Questions & Answers

Emergency Diagnostics Information

Ebola Virus EUA Information (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#ebola)

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Coronavirus Disease 2019 (COVID-19) EUA Information

In Vitro Diagnostic Products

In Vitro Diagnostic Products

Test Kit Manufacturers and Commercial Laboratories

High Complexity Molecular-Based Laboratory Developed Tests

Fact Sheet for Healthcare Providers (/media/136599/download) (PDF, 134 KB)

Fact Sheet for Patients (/media/136600/download) (PDF, 123 KB)

High Complexity Molecular-Based Laboratory Developed Tests

Personal Protective Equipment

Declaration that Circumstances

Other Medical Devices

Please see Recent Final Medical Device Guidance Documents (/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-

Ebola Virus EUA Information

Ebola preparedness and response updates from FDA (/emergency-preparedness-and-response/mcm-issues/ebola-preparedness-and-response-updates-

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

Instructions for Use

Instructions for Use

back to list of current EUAs (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#current)

Enterovirus D68 (EV-D68) EUA Information

back to list of current EUAs (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#current)

Freeze Dried Plasma Information

back to list of current EUAs (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#current)

H7N9 Influenza EUA Information

back to list of current EUAs (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#current)

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

Instructions for Use

back to list of current EUAs (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#current)

Nerve Agent EUA Information

January 2nd letter granting EUA

back to list of current EUAs (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#current)

Zika Virus EUA Information

Zika virus response updates from FDA (/emergency-preparedness-and-response/mcm-issues/zika-virus-response-updates-fda)

Zika virus diagnostic development information (/emergency-preparedness-and-response/mcm-issues/zika-virus-diagnostic-development)

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

Letter granting EUA amendment(s)

September 27, Authorization FR notice Healthcare Emergency Use of In Vitro Diagnos

back to list of current EUAs (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#current)

Emergency Use Authorization--Archived Information (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization-archived-

21st Century Cures Act: MCM-Related Cures Provisions (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) (/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/pandemic-

Public Readiness and Emergency Preparedness (PREP) Act (https://www.phe.gov/preparedness/legal/prepact/pages/default.aspx)

HHS Public Health Emergency EUA Authorization Declarations (http://www.phe.gov/emergency/news/healthactions/Lists/EUA/AllItems.aspx)

Ebola Preparedness and Response Updates from FDA (/emergency-preparedness-and-response/mcm-issues/ebola-preparedness-and-response-updates-fda)

Emergency Use Authorizations (Medical Devices) (/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations)

Historical Information about Device Emergency Use Authorizations (/medical-devices/emergency-situations-medical-devices/historical-information-about-device-emergency-use-

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