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  1. MCM Legal, Regulatory and Policy Framework

Emergency Use Authorization

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About Emergency Use Authorizations (EUAs)

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize 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 certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.

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 EUAs. 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. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below.

Information on terminated and revoked EUAs can be found in archived information.

Public Readiness and Emergency Preparedness Act (PREP Act) 

Information on the PREP Act can be found here.

The PREP Act amended the Public Health Service Act (PHS Act) to add section 319F-3 (42 U.S.C. 247d-6d).  The HHS Secretary has issued several Declarations pursuant to section 319F-3 of the PHS Act to provide liability immunity for activities related to medical countermeasures against COVID-19. 

PREP Act - COVID-19 Related Information

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 addition, 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.

 


Coronavirus Disease 2019 (COVID-19) EUA Information

Vaccines

The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.

For additional information about COVID-19 vaccines, see:

Date of First EUA Issuance Most Recent Letter of Authorization (PDF) Authorized Use Fact Sheets and Manufacturer Instructions/ Package Insert (PDF) Federal Register Notice for EUA
02/27/2021

Janssen COVID-19 Vaccine (409KB) (Reissued June 10, 2021)

Letter Granting EUA Amendment (March 29, 2021) (152KB)

Letter Granting EUA Amendment (April 23, 2021) (229KB)

Concurrence Letter (June 10, 2021) (26KB)

Concurrence Letter (June 15, 2021) (57KB)

For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older

Healthcare Providers (470KB)

Recipients and Caregivers (242KB)

Frequently Asked Questions on the Janssen COVID-19 Vaccine

Decision Memorandum (974KB, February 2021 initial EUA issuance)

Decision Memorandum (362KB, June 2021 EUA reissuance)

Decision Memorandum Addendum (59KB, June 2021 EUA reissuance)

More information about the Janssen COVID-19 Vaccine

COVID-19 Vaccine Expiration Dating Extensions

 
12/18/2020

Moderna COVID-19 Vaccine (392KB) (Reissued February 25, 2021)

Letter Granting EUA Amendment (April 1, 2021) (193KB)

For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older

Healthcare Providers (501KB)

Recipients and Caregivers (251KB)

Decision Memorandum (769KB)

Frequently Asked Questions on the Moderna COVID-19 Vaccine

More information about the Moderna COVID-19 Vaccine

12/11/2020

Pfizer-BioNTech COVID-19 Vaccine (217KB) (Reissued February 25, 2021 and May 10, 2021)

Letter Granting EUA Amendment (January 6, 2021) (164KB)

Letter Granting EUA Amendment (January 22, 2021) (190KB)

Letter Granting EUA Amendment (April 6, 2021) (166KB)

Letter Granting EUA Amendment (May 19, 2021) (184KB)

For the prevention of 2019 coronavirus disease (COVID-19) for individuals 12 years of age and older

Healthcare Providers (959KB)

Recipients and Caregivers (155KB)

Decision Memorandum (709KB, December 2020 initial EUA issuance)

Decision Memorandum (868KB, May 2021 EUA reissuance)

Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine

More information about the Pfizer-BioNTech COVID-19 Vaccine

Drug and Biological Therapeutic Products

The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.

Related information: FDA Combating COVID-19 With Therapeutics (PDF, 610 KB)

Date of First EUA Issuance Most Recent Letter of Authorization (PDF) Authorized Use 1 Fact Sheets and Manufacturer Instructions/ Package Insert (PDF) Federal Register Notice for EUA
05/26/2021 Sotrovimab (388KB) For the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Healthcare Providers (467KB)

Patients, Parents, and Caregivers (140KB)

Frequently Asked Questions on the Emergency Use Authorization of Sotrovimab (288KB)

None currently
03/12/2021 Propofol‐Lipuro 1% (344KB) To maintain sedation via continuous infusion in patients greater than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting. 2

Healthcare Providers (420KB)

Patients, Parents, and Caregivers (172KB)

None currently
02/09/2021 Bamlanivimab and Etesevimab (344KB) (Reissued February 25, 2021) For the treatment of mild-to-moderate COVID-19 in adult and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Healthcare Providers (550KB) (updated May 14, 2021)

Patients, Parents, and Caregivers (130KB) (updated May 14, 2021)

  • Spanish (131KB) (updated May 14, 2021)

Dear Healthcare Provider Letter (370KB)

Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab and Etesevimab (267KB) (updated May 19, 2021)

Important update about bamlanivimab/etesevimab with regard to the P.1 variant in the state of Illinois (from ASPR and FDA, May 7, 2021)

Important update about bamlanivimab/etesevimab with regard to the P.1 variant in the state of Massachusetts (from ASPR and FDA, May 21, 2021)

Important update about bamlanivimab/etesevimab with regard to the P.1 and the B.1.351 variants in multiple states (from ASPR and FDA, May 26, 2021)

CDER Scientific Review Documents Supporting EUA

None currently
11/21/2020 REGEN-COV (Casirivimab and Imdevimab) (378KB) (Reissued February 3, 2021, February 25, 2021 and June 3, 2021) Casirivimab and imdevimab to be administered together for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Healthcare Providers (608KB) (updated June 3, 2021)

Patients, Parents, and Caregivers (147KB) (updated June 3, 2021)

  • Spanish (75KB) (updated May 14, 2021)

Dear Healthcare Provider Letter (567KB) (updated June 3, 2021)

Frequently Asked Questions on the Emergency Use Authorization of REGEN-COV (Casirivimab and Imdevimab) (311KB) (updated June 4, 2021)

CDER Scientific Review Documents Supporting EUA

11/19/2020 Baricitinib (Olumiant) in Combination with remdesivir (Veklury) (322KB) For emergency use by healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Healthcare Providers (155KB)

Patients, Parents, and Caregivers (55KB)

Frequently Asked Questions on the Emergency Use Authorization for Olumiant (baricitinib) in Combination with Veklury (remdesivir) for Treatment of Mild to Moderate COVID-19 (270KB)

CDER Scientific Review Documents Supporting EUA

08/23/2020

COVID-19 convalescent plasma (285KB) (Reissued February 23, 2021 and March 9, 2021)

Letter Granting EUA Amendment (June 2, 2021) (107KB)

For the treatment of hospitalized patients with Coronavirus Disease 2019 (COVID-19)

Healthcare Providers (176KB)

Patients and Parents/ Caregivers (124KB)

Decision Memorandum (166KB)

08/13/2020 REGIOCIT replacement solution that contains citrate for regional citrate anticoagulation (RCA) of the extracorporeal circuit (92KB) To be used as a replacement solution only in adult patients treated with continuous renal replacement therapy (CRRT), and for whom regional citrate anticoagulation is appropriate, in a critical care setting Healthcare Providers (108KB)

Patients and Caregivers (52KB)

REGIOCIT package insert for EUA (140KB)
05/08/2020 Fresenius Kabi Propoven 2% (209KB) To maintain sedation via continuous infusion in patients older than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting 2  Healthcare Providers (288KB)

Patients and Parent/Caregivers (39KB)

Propoven 2% Wall Chart (2.4MB)
05/01/2020 Remdesivir for Certain Hospitalized COVID-19 Patients (423KB) (Reissued August 28, 2020, October 1, 2020, and October 22, 2020)

For emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.

On October 22, 2020, FDA approved Veklury (remdesivir) for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.  This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the EUA for Veklury continues to authorize Veklury for emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.

For additional information, also see: FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness

Healthcare Providers (375KB)

Patients and Parent/ Caregivers (94KB)

Frequently Asked Questions on the EUA for Veklury (remdesivir) for Certain Hospitalized Patients (194KB) (Updated February 4, 2021)

04/30/2020 Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions (171KB) 3
[also listed under Medical Device EUAs]
To provide continuous renal replacement therapy (CRRT) to treat patients in an acute care environment during the COVID-19 pandemic.

Healthcare Providers (135KB)

Patients (125KB)

Instructions for Use, Bloodline/ Tubing (83KB)

Instructions for Use, UltraFlux (147KB)

Instructions for Use, multiFiltratePRO (15.07MB)

Summary of Product Characteristics (SmPC) (308KB)

Instructions for Use, MultiPlus (110KB)

1 The virus that causes COVID-19 has led to an increased number of patients requiring critical care, such as  with severe respiratory illness. As a result, there is a shortage of adequate, FDA-approved  drugs used for their treatment, such as propofol for sedation of mechanically ventilated patients.  

2 In the circumstances of this public health emergency, it would not be feasible to require healthcare providers to seek to limit Fresenius Propoven 2% Emulsion or Propofol-Lipuro 1% only to be used for patients with suspected or confirmed COVID-19; therefore, this authorization does not limit use to such patients.

3 The multiBic/multiPlus Solutions include multiBic dialysate and replacement fluid and multiPlus dialysate. The multiBic replacement fluid is regulated as a drug by CDER. The multiFiltrate PRO System, multiBic dialysate and the multiPlus dialysate solutions are regulated as devices by CDRH.

Information About COVID-19 EUAs for Medical Devices

Information about COVID-19 EUAs for medical devices can be found below and at: Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.

On February 4, 2020, the Secretary determined pursuant to section 564 of the FD&C Act 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 a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV).

On the basis of this determination, the HHS Secretary issued three declarations related to medical devices:

  • Determination of Public Health Emergency (effective February 4, 2020), and declaration 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
  • Emergency Use Declaration (effective March 2, 2020), that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak
  • Emergency Use Authorization Declaration (effective March 24, 2020), 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

For identification of the applicable declaration for each EUA, please see each EUA letter of authorization and/or the corresponding Federal Register notice.

Related information: FDA Combating COVID-19 With Medical Devices (PDF, 708 KB)

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Other 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.

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