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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

On May 9, 2023, HHS Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The Secretary issued this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024.

Additional resources:

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

FDA expects the COVID-19 public health emergency (PHE) declared by the Department of Health and Human Services under the Public Health Service Act to expire on May 11, 2023. The ending of the COVID-19 PHE will not impact FDA's ability to authorize medical countermeasures for emergency use. Existing COVID-19 EUAs will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so. Read more about what happens to EUAs when a public health emergency ends.

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:

Note: In the table below, the Additional Information column contains links to information including fact sheets, EUA letters of authorization, regulatory information, decision memos, health care provider information, and Federal Register notices.

Date of First EUA Issuance Product Authorized Use Additional Information
07/13/2022

Novavax COVID-19 Vaccine, Adjuvanted

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

More information about the Novavax COVID-19 Vaccine

Novavax COVID-19 Vaccine, Adjuvanted decision memos and regulatory documents (ZIP file)

12/18/2020

Moderna COVID-19 Vaccine 

For the prevention of 2019 coronavirus disease (COVID-19) in individuals 6 months and older

On January 31, 2022, FDA approved the Moderna COVID-19 Vaccine, now known as Spikevax, for the prevention of COVID-19.

More information about the Moderna COVID-19 Vaccine

Moderna COVID-19 Vaccine decision memos and regulatory documents (ZIP file)

12/11/2020

Pfizer-BioNTech COVID-19 Vaccine

For the prevention of 2019 coronavirus disease (COVID-19) in individuals 6 months and older

On August 23, 2021, FDA approved the Pfizer-BioNTech COVID-19 Vaccine, now known as Comirnaty, for the prevention of COVID-19.

More information about the Pfizer-BioNTech COVID-19 Vaccine

Pfizer-BioNTech COVID-19 Vaccine decision memos and regulatory documents (ZIP file)

Convalescent Plasma

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 EUA subsequently issued by FDA is listed in the table below this blue box.

Also see: Recommendations for Investigational COVID-19 Convalescent Plasma

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
08/23/2020

COVID-19 convalescent plasma (365KB) (Reissued February 23, 2021, March 9, 2021 and December 28, 2021)

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

Letter Granting EUA Amendment (February 9, 2022) (26KB)

 

COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies is authorized for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment, in inpatient or outpatient settings.

Healthcare Providers (Updated December 28, 2021) (192KB)

Patients and Parents/ Caregivers (Updated December 28, 2021) (151KB)

Decision Memorandum (166KB)

Decision Memorandum (December 27, 2021) (242KB)
 

 

Drugs and Non-Vaccine Biological Products

View the list Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products, for additional information including letters of authorization, fact sheets, Dear Health Care Provider letters, and additional information about COVID-19 therapeutics.

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 on the page: Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products.

View the FDA’s COVID-19 Drugs page to see all products approved to treat COVID-19 without any remaining EUA authorized uses.

Revocation notices for COVID-19 drug and biological product EUAs are available at: Emergency Use Authorization--Archived Information.

Related links:

 

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.

Transition guidances update

March 24, 2023 - The FDA finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA’s recommendations for: 

  • Developing a transition implementation plan, 
  • Submitting a marketing submission, and 
  • Taking other actions with respect to these devices.

The FDA encourages stakeholders to review the two final guidances, attend the webinar noted below, and reach out to the FDA if they have questions. In particular, for manufacturers that are planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.

Additional resources:

Declaration and determination

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:

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

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mpox EUA Information

mpox Vaccine EUAs

On November 28, 2022, the World Health Organization announced, and the U.S. government supported, renaming monkeypox disease to mpox. In response to this action by the WHO, federal public health agencies will adopt the mpox name in correspondence with the medical community and American public from this point forward.

Effective August 9, 2022, pursuant to section 564 of the FD&C Act, the HHS Secretary declared:

  • There is a public health emergency related to monkeypox, or significant potential for a public health emergency, that affects, or has the significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus; and  
  • On the basis of this determination, circumstances exist justifying the authorization of emergency use of vaccines.

Vaccine EUAs subsequently issued by FDA are listed in the table below.

PREP Act declaration: Effective September 28, 2022, the HHS Secretary amended the declaration first issued on October 10, 2008, and amended and republished effective January 1, 2016 for smallpox countermeasures and countermeasures against other orthopoxviruses pursuant to section 319F-3 of the Public Health Service Act to emphasize that the declaration applies to monkeypox virus, to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox (variola virus), monkeypox virus, and other orthopoxviruses in a declared emergency, and to extend the duration of the declaration. About PREP Act declarations

Date of First EUA Issuance Letter of Authorization (PDF) Authorized Use Fact Sheets and Manufacturer Instructions/Package Insert  (PDF) Additional Information and Decision Memoranda (PDF) Federal Register Notice for EUA
August 9, 2022

Jynneos (602KB)

Letter granting EUA amendment (August 16, 2022) (133KB)

  • Active immunization by subcutaneous injection for prevention of monkeypox disease in individuals less than 18 years of age determined to be at high risk for monkeypox infection, and
  • Active immunization by intradermal injection for prevention of monkeypox disease in individuals 18 years of age and older determined to be at high risk for monkeypox infection.

Healthcare Providers (343KB) (updated August 16, 2022)

Recipients and Caregivers (465KB)

Dear Healthcare Provider Letter (290KB)

Decision Memorandum (295KB)

Authorization of Emergency Use of a Biological Product in Response to an Outbreak of Monkeypox; Availability (October 7, 2022)

mpox In Vitro Diagnostics EUAs

Effective September 7, 2022, pursuant to section 564 of the FD&C Act, the HHS Secretary declared

  • On the basis of the August 9th determination, the Secretary of HHS has subsequently declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. See from HHS: HHS Secretary Becerra Issues 564 Declaration to Expand the Availability of Testing for Monkeypox

Diagnostic EUAs subsequently issued by FDA are listed in the table on this page: Monkeypox Emergency Use Authorizations for Medical Devices.

Additional information for product developers is available at:

Note that FDA previously cleared real-time polymerase chain reaction (PCR) tests that detect non-variola orthopoxvirus DNA, including the virus that causes mpox. Learn more about these tests: Monkeypox Tests (In Vitro Diagnostic (IVD) Devices)

Date of First EUA Issuance Additional Information Federal Register Notices
September 7, 2022

On October 20, 2022, FDA also published lists of certain laboratories that have notified FDA of their laboratory developed monkeypox diagnostic test (LDT), modification to an FDA-cleared or EUA-authorized monkeypox diagnostic test, or laboratory developed monkeypox serology test, as described in Sections IV.A.2, IV.A.3, and IV.C, respectively, of the Policy for Monkeypox Tests to Address the Public Health Emergency. While FDA has not reviewed the laboratory’s validation of the listed tests and has not issued EUAs for these tests, we are providing this information to promote transparency. 

For additional information about monkeypox (mpox), see: FDA mpox Response and Monkeypox and Medical Devices.

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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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Related Links

Influenza Diagnostic Tests - In response to requests from the public, FDA is providing a list of in vitro diagnostic tests that have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA), for the detection of influenza in certain specimens from humans. Most tests listed on this page for the detection of seasonal influenza may be capable of detecting influenza A/H5N1, which is a subtype of influenza A. However, only tests specifically designed for subtyping will be able to determine if the person has seasonal flu, or influenza A/H5. (May 2024)

 

 

 
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