Emergency Use Authorization
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), 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.
Questions & Answers
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
- Emergency Use Authorizations (current device EUAs)
- How to Submit a Pre-EUA for In vitro Diagnostics (IVDs) to FDA (for test manufacturers)
- Information for Laboratories Implementing IVD Tests Under EUA
Current EUAs
The tables below provide information on current EUAs:
- Anthrax: Doxycycline Mass Dispensing EUA Information and National Postal Model Anthrax EUA Information
- Ebola Virus EUA Information
- Enterovirus D68 (EV-D68) EUA Information
- Freeze Dried Plasma Information
- H7N9 Influenza EUA Information
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
- Nerve Agent EUA Information
- Zika Virus EUA Information
Information about EUAs that are no longer in effect is available on our EUA archive page.
Anthrax: Doxycycline Mass Dispensing EUA Information*
*Note: Based on the April 13, 2016, issuance of the Doxycycline Emergency Dispensing Order and Doxycycline Emergency Use Instructions (EUI), which replace the need for an EUA for doxycycline mass dispensing, this EUA will be terminated by FDA. Notice of such termination will be published in the Federal Register.
More: current drug information related to anthrax, from the Center for Drug Evaluation and Research
Anthrax: National Postal Model Anthrax EUA Information
| 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) |
|---|---|---|---|---|---|---|
|
Oral formulations of doxycycline products for the post-exposure prophylaxis (PEP) of inhalational anthrax |
October 14, 2011
(originally issued on October 6, 2008, with subsequent amendments) |
Amendment to the Letter of Authorization (October 14, 2011) (PDF, 7 MB)
Amendment to the Letter of Authorization (February 25, 2009) (PDF, 97 KB) |
|
Renewal of Declaration ... (July 20, 2012) Renewal of Declaration ... (July 20, 2011) Renewal of Declaration ... (October 1, 2010) Renewal of Declaration ... (October 1, 2009) Determination and Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information – Federal Register (October 1, 2008) |
Anthrax Medical Countermeasures-Amendment (December 9, 2015) |
Ebola Virus EUA Information
Additional information on Ebola virus EUAs (diagnostics)
Ebola preparedness and response updates from FDA (all agency activities)
Enterovirus D68 (EV-D68) EUA Information
| 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) |
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) |
H7N9 Influenza EUA Information
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
| 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 |
|
||
| RealStar® MERS-CoV RT-PCR Kit U.S. |
July 17, 2015 February 12, 2016 (reissuance)
|
Authorization (PDF, 238 KB) | FR notice |
|
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) Amended May 23, 2017 Amended January 24, 2018 Amended March 6, 2018 Amended May 15, 2018 |
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) |
|
|
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) |
Zika Virus EUA Information
Zika virus diagnostic development information
Draft EUA review templates for Zika are available by email request to: CDRH-ZIKA-Templates@fda.hhs.gov
Related Links
Summary of Process for EUA Issuance Emergency Use Authorization--Archived Information Emergency Dispensing Orders 21st Century Cures Act: MCM-Related Cures Provisions Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) - Public Readiness and Emergency Preparedness (PREP) Act
HHS Public Health Emergency EUA Authorization Declarations Ebola Response Updates from FDA [ARCHIVED]Zika Virus Response Updates from FDA - Emergency Use Authorizations (Medical Devices)
Historical Information about Device Emergency Use Authorizations