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In this section: MCM Legal, Regulatory and Policy Framework
* MCM Legal, Regulatory and Policy Framework
* Emergency Use Authorization
* Expiration Dating Extension
* MCM Emergency Use Authorities
* MCM-Related Counterterrorism Legislation
* MCM-Related Legal and Policy Presentations, Publications and Q&As
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* Vaccine EUA Questions and Answers for Stakeholders
* FAQs: What happens to EUAs when a public health emergency ends?
1. Home
2. Emergency Preparedness and Response
3. Counterterrorism and Emerging Threats
4. Medical Countermeasures Initiative (MCMi)
5. MCM Legal, Regulatory and Policy Framework
6. Emergency Use Authorization
1. MCM Legal, Regulatory and Policy Framework
EMERGENCY USE AUTHORIZATION
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On this page:
* About Emergency Use Authorizations (EUAs)
* PREP Act
* EUA Guidance
* COVID-19 EUAs
* Vaccines
* Convalescent Plasma
* Drugs and Non-Vaccine Biological Products
* Information About COVID-19 EUAs for Medical Devices (including diagnostic
tests)
* mpox EUAs
* Vaccines
* Diagnostic tests (monkeypox virus)
* Other Current EUAs
* Related Links
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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
* Notice of Declaration under the Public Readiness and Emergency Preparedness
Act for medical countermeasures against COVID-19 (February 4, 2020)
* COVID-19 PREP Act Declarations and Amendments (HHS)
* Advisory Opinion 02-02 on the PREP Act and the Secretary's Declaration under
the Act (PDF, 278 KB, May 19, 2020)
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.
* Coronavirus Disease (COVID-19) updates from FDA
* Detailed Information for all COVID-19 EUAs, including authorizations and fact
sheets
* COVID-19 EUAs for Vaccines
* COVID-19 EUA for Convalescent Plasma
* COVID-19 EUAs for Drugs and Non-Vaccine Biological Products
* COVID-19 EUAs for Medical Devices, including:
* Blood Purification Devices EUAs
* Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
* In Vitro Diagnostics EUAs
* Decontamination Systems for Personal Protective Equipment EUAs
* Infusion Pump EUAs
* Personal Protective Equipment EUAs
* Remote or Wearable Patient Monitoring Devices EUAs
* Respiratory Assist Devices EUAs
* Ventilators and Ventilator Accessories EUAs
* Other Medical Device EUAs
* Information About COVID-19 EUAs for Medical Devices
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.
* Determination of a Public Health Emergency and Declaration that Circumstances
Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act
(February 4, 2020)
* Amended Determination of a Public Health Emergency or Significant Potential
for a Public Health Emergency Pursuant to Section 564(b) of the FD&C Act
(effective March 15, 2023; Federal Register notice March 20, 2023)
* Emergency Use Authorization Declaration (March 27, 2020)
For additional information about COVID-19 vaccines, see:
* COVID-19 Vaccines
* Emergency Use Authorization for Vaccines Explained
* Infographic: The Path for a COVID-19 Vaccine From Research to Emergency Use
Authorization (PDF, 723 KB)
* Vaccine EUA Questions and Answers for Stakeholders
Search:
Show 102550100All entries
Date of First EUA IssuanceMost Recent Letter of Authorization (PDF)Authorized
UseFact Sheets and Manufacturer Instructions/Package Insert (PDF)Additional
Information and Decision Memoranda (PDF)Federal Register Notice for
EUA07/13/2022
Novavax COVID-19 Vaccine, Adjuvanted (892KB) (Reissued August 19, September 12,
and October 19, 2022)
Letter Granting EUA Amendment (March 28, 2023) (187KB)
For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18
years of age and older
Healthcare Providers (600KB, updated March 28, 2023)
Recipients and Caregivers (708KB, updated October 19, 2022)
* View the Fact Sheet for Recipients and Caregivers in multiple additional
languages
More information about the Novavax COVID-19 Vaccine
Decision Memorandum (2.16MB, July 13, 2022)
Decision Memorandum (1.81MB, August 19, 2022)
Decision Memorandum (812KB, October 19, 2022)
* Federal Register notice, August 29, 2022
02/27/2021
Janssen COVID-19 Vaccine (413KB) (Reissued June 10, October 20 and November 19,
2021, May 5, 2022, and March 13, 2023)
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)
Concurrence Letter (June 16, 2021) (70KB)
Concurrence Letter (July 2, 2021) (317.7KB)
Letter Granting EUA Amendment (July 12, 2021) (210KB)
Concurrence Letter (July 13, 2021) (213KB)
Concurrence Letter (July 28, 2021) (63KB)
Letter Granting EUA Amendment (August 30, 2021) (80KB)
Concurrence Letter (September 8, 2021) (353KB)
Concurrence Letter (September 14, 2021) (253KB)
Concurrence Letter (September 29, 2021) (28KB)
Concurrence Letter (November 5, 2021) (212KB)
Letter Granting EUA Amendment (December 14, 2021) (253KB)
Letter Granting EUA Amendment (January 11, 2022) (439KB)
Letter Granting EUA Amendment (January 31, 2022) (393KB)
Concurrence Letter (March 4, 2022) (33KB)
Concurrence Letter (April 7, 2022) (136KB)
For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18
years of age and older for whom other FDA-authorized or approved COVID-19
vaccines are not accessible or clinically appropriate, and in individuals 18
years of age and older who elect to receive the Janssen COVID-19 Vaccine because
they would otherwise not receive a COVID-19 vaccine
Healthcare Providers (634KB, updated March 13, 2023)
Recipients and Caregivers (294KB, updated March 13, 2023)
* View the Fact Sheet for Recipients and Caregivers in multiple additional
languages
More information about the Janssen COVID-19 Vaccine
COVID-19 Vaccine Expiration Dating Extensions
Decision Memorandum (974KB, February 2021 initial EUA issuance)
Decision Memorandum (362KB, June 2021 EUA reissuance)
Decision Memorandum Addendum (59KB, June 2021 EUA reissuance)
Decision Memorandum Addendum (61KB, July 1, 2021 Assessment of Certain Janssen
COVID-19 Vaccine Batches)
Decision Memorandum Addendum (58KB, July 13, 2021 Assessment of Certain Janssen
COVID-19 Vaccine Batches)
Decision Memorandum Addendum (60KB, September 8, 2021 Assessment of Certain
Janssen COVID-19 Vaccine Batches)
Decision Memorandum Addendum (55KB, September 14, 2021 Assessment of Certain
Janssen COVID-19 Vaccine Batches)
Decision Memorandum Addendum (57KB, September 29, 2021 Assessment of Certain
Janssen COVID-19 Vaccine Batches)
Decision Memorandum (605KB, October 20, 2021 EUA reissuance)
Memorandum to the File (940KB, October 20, 2021 EUA amendment to support use of
a Janssen COVID-19 Vaccine heterologous booster dose following primary
vaccination with other authorized COVID-19 vaccines)
Decision Memorandum Addendum (59KB, November 5, 2021 Assessment of Certain
Janssen COVID-19 Vaccine Batches)
Decision Memorandum Addendum (64KB, November 18, 2021)
Review Memorandum (86KB, December 22, 2021)
Addendum to Dec. 22, 2021 Review Memorandum (398KB, December 22, 2021)
Decision Memorandum Addendum (87KB, December 30, 2021)
Decision Memorandum Addendum (87KB, January 6, 2022)
Review Memorandum (84KB, January 7, 2022)
Addendum to Jan 7, 2022 Review Memorandum (81KB, January 7, 2022)
Decision Memorandum (257KB, May 5, 2022)
Decision Memorandum (542KB, March 13, 2023)
* Federal Register notice, May 27, 2021
12/18/2020
Moderna COVID-19 Vaccine (1.43MB) (Reissued February 25, July 7, August 12,
October 20, and November 19, 2021, January 7, January 31, March 15, March 29,
June 17, August 31, October 12, and December 8, 2022)
Letter Granting EUA Amendment (April 1, 2021) (193KB)
Letter Granting EUA Amendment (June 25, 2021) (90KB)
Letter Granting EUA Amendment (August 30, 2021) (58KB)
Letter Granting EUA Amendment (December 9, 2021) (192KB)
Concurrence Letter (September 20, 2022) (886KB)
Concurrence Letter (September 26, 2022) (137KB)
Concurrence Letter (September 28, 2022) (139KB)
Concurrence Letter (October 6, 2022) (174KB)
Concurrence Letter (October 14, 2022) (177KB)
Concurrence Letter (October 20, 2022) (172KB)
Concurrence Letter (October 28, 2022) (190KB)
Concurrence Letter (November 4, 2022) (138KB)
Concurrence Letter (November 4, 2022) (177KB)
Concurrence Letter (November 19, 2022) (171KB)
Concurrence Letter (November 28, 2022) (176KB)
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.
Healthcare Providers (1.74MB, updated December 8, 2022) – labels with magenta
borders - 6 months through 5 years of age
Healthcare Providers (1.92MB) – Bivalent Booster labels with yellow borders - 6
months through 5 years of age
Healthcare Providers (1.70MB, updated December 8, 2022) – labels with purple and
teal borders - 6 years through 11 years of age
Healthcare Providers (1.74MB, updated December 8, 2022) – labels with light blue
borders
Healthcare Providers (2.06MB, updated December 8, 2022) – Bivalent Booster for 6
years and older, gray borders
Recipients and Caregivers (762KB, updated December 8, 2022) – 6 months through 5
years of age
Recipients and Caregivers (779KB, updated December 8, 2022) - 6 years and older
* View the Fact Sheet for Recipients and Caregivers in multiple additional
languages
Moderna Dear Healthcare Provider Letter (610KB, September 7, 2022)
Moderna Dear Healthcare Provider Letter (628KB, October 12, 2022)
Moderna Dear Healthcare Provider Letter (678KB, December 8, 2022)
Important Prescribing Information for Vaccine Providers on Vial Presentation
Available to Provide Doses for Ages 6 Years Through 11 Years (719KB, August 31,
2022)
Moderna COVID-19 Vaccine Presentations Wall Chart (441KB, updated March 12,
2023)
More information about the Moderna COVID-19 Vaccine
Decision Memorandum (769KB)
Decision Memorandum (65KB, August 12, 2021 EUA reissuance)
Decision Memorandum (606KB, October 20, 2021 EUA reissuance)
Memorandum to the File (605KB, October 20, 2021 EUA amendment to support use of
a Moderna COVID-19 Vaccine heterologous booster dose following primary
vaccination with other authorized COVID-19 vaccines)
Decision Memorandum Addendum (89KB, November 18, 2021)
Decision Memorandum (85KB, November 19, 2021)
Decision Memorandum Addendum (101KB, November 19, 2021)
Decision Memorandum Addendum (92KB, December 30, 2021)
Decision Memorandum (112KB, January 6, 2022)
Decision Memorandum (278KB, March 28, 2022)
Decision Memorandum (2.48MB, June 17, 2022)
Decision Memorandum (703KB, August 31, 2022)
Decision Memorandum (193KB, September 20, 2022)
Decision Memorandum Addendum (183KB, September 26, 2021)
Decision Memorandum Addendum #2 (188KB, September 28, 2021)
Decision Memorandum Addendum #3 (183KB, October 6, 2022)
Decision Memorandum Addendum #4 (184KB, October 14, 2022)
Decision Memorandum Addendum #5 (183KB, October 20, 2022)
Decision Memorandum (2.63MB, October 12, 2022)
Decision Memorandum Addendum #6 (184KB, October 28, 2022)
Decision Memorandum Addendum #7 (183KB, November 4, 2022)
Decision Memorandum Addendum #8 (183KB, November 19, 2022)
Decision Memorandum Addendum #9 (182KB, November 28, 2022)
Decision Memorandum (865KB, December 8, 2022)
* Federal Register notice, January 19, 2021
12/11/2020
Pfizer-BioNTech COVID-19 Vaccine (648KB) (Reissued February 25, May 10, June 25,
August 12, August 23, September 22, October 20, October 29, November 19,
December 9, December 16, 2021, January 3, March 29, May 17, June 17, July 8,
August 31, October 12, December 8, 2022, and March 14, 2023)
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)
Concurrence Letter (August 22, 2021) (68KB)
Letter Granting EUA Amendment (September 1, 2021) (98KB)
Letter Granting EUA Amendment (January 31, 2022) (170KB)
Letter Granting EUA Amendment (April 13, 2022) (375KB)
Letter Granting EUA Amendment (April 26, 2022) (179KB)
Letter Granting EUA Amendment (June 1, 2022) (164KB)
Letter Granting EUA Amendment (June 28, 2022) (128KB)
Letter Granting EUA Amendment (October 18, 2022) (203KB)
Letter Granting EUA Amendment (November 22, 2022) (347KB)
Letter Granting EUA Amendment (December 22, 2022) (204KB)
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.
Healthcare Providers (1.58MB, updated March 14, 2023) –for-6 months through 4
years of age, maroon cap (must dilute)
Healthcare Providers (2.41MB, updated December 8, 2022) – for 5-11 years of age,
orange cap (must dilute)
Healthcare Providers (2.60MB, updated December 8, 2022) – Bivalent Booster for
5-11 years of age, orange cap (must dilute)
Healthcare Providers (1.29MB, updated December 22, 2022) – for 12 years of age
and older, purple cap (must dilute)
Healthcare Providers (2.62MB, updated December 8, 2022) – for 12 years of age
and older, gray cap (no dilution)
Healthcare Providers (2.37MB, updated December 8, 2022) – Bivalent Booster for
12 years of age and older, gray cap (no dilution)
Recipients and Caregivers (210KB, updated March 14, 2023) –for-6 months through
4 years of age
Recipients and Caregivers (663KB, updated December 8, 2022) – 5-11 years of age
Recipients and Caregivers (671KB, updated December 8, 2022) –12 years of age and
older
* View the Fact Sheet for Recipients and Caregivers in multiple additional
languages
Pfizer Dear Healthcare Provider Letter (200KB, June 17, 2022)
Pfizer Dear Healthcare Provider Letter (395KB, August 31, 2022)
Pfizer Dear Healthcare Provider Letter (386KB, October 12, 2022)
Pfizer Dear Healthcare Provider Letter (281KB, December 8, 2022)
Pfizer-BioNTech COVID-19 Vaccine Presentations Wall Chart (588KB, January 10,
2023)
More information about the Pfizer-BioNTech COVID-19 Vaccine
COVID-19 Vaccine Expiration Dating Extensions
Decision Memorandum (709KB, December 2020 initial EUA issuance)
Decision Memorandum (868KB, May 2021 EUA reissuance)
Decision Memorandum (93KB, August 12, 2021 EUA reissuance)
Decision Memorandum (362KB, September 24, 2021)
Decision Memorandum (630KB, October 20, 2021 EUA reissuance)
Decision Memorandum (508KB, October 29, 2021)
Decision Memorandum (135KB, November 19, 2021)
Decision Memorandum Addendum (96KB, November 19, 2021)
Decision Memorandum (135KB, December 8, 2021)
Decision Memorandum (140KB, December 30, 2021)
Decision Memorandum Addendum (87KB, January 6, 2022)
Decision Memorandum (279KB, March 28, 2022)
Decision Memorandum (481KB, May 17, 2022
Decision Memorandum (973KB, June 17, 2022)
Decision Memorandum (962KB, August 31, 2022)
Decision Memorandum (382KB, October 12, 2022)
Decision Memorandum (394KB, December 8, 2022)
Decision Memorandum (602KB, March 14, 2023)
* Federal Register notice, January 19, 2021
Showing 1 to 4 of 4 entries
* Previous
* 1
* Next
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.
* Determination of a Public Health Emergency and Declaration that Circumstances
Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act
(February 4, 2020)
* Amended Determination of a Public Health Emergency or Significant Potential
for a Public Health Emergency Pursuant to Section 564(b) of the FD&C
Act (effective March 15, 2023; Federal Register notice March 20, 2023)
* Emergency Use Authorization Declaration (March 27, 2020)
Also see: Recommendations for Investigational COVID-19 Convalescent Plasma
Search:
Show 102550100All entries
Date of First EUA IssuanceMost Recent Letter of Authorization (PDF)Authorized
UseFact Sheets and Manufacturer Instructions/Package Insert (PDF)Federal
Register Notice for EUA08/23/2020
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)
* Federal Register notice, February 19, 2021
Showing 1 to 1 of 1 entries
* Previous
* 1
* Next
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.
* Determination of a Public Health Emergency and Declaration that Circumstances
Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act
(February 4, 2020)
* Amended Determination of a Public Health Emergency or Significant Potential
for a Public Health Emergency Pursuant to Section 564(b) of the FD&C Act
(effective March 15, 2023; Federal Register notice March 20, 2023)
* Emergency Use Authorization Declaration (March 27, 2020)
COVID-19 EUA FAERS PUBLIC DASHBOARD
The dashboard provides weekly updates of adverse event reports submitted to
FAERS for drugs and therapeutic biological products used under EUA during the
COVID-19 public health emergency. After launching the FAERS Public Dashboard,
click on the COVID-19 EUA link at the top of the home page to open the COVID-19
EUA FAERS Public Dashboard.
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:
* CDER Scientific Review Documents Supporting Emergency Use Authorizations for
Drug and Biological Therapeutic Products | COVID-19
* Expiration Dating Extension – COVID-19 Therapeutics
* Office of the Assistant Secretary for Preparedness and Response (ASPR)
Important Updates: COVID-19 Therapeutics
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:
* Transition Plan for Medical Devices That Fall Within Enforcement Policies
Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
* Transition Plan for Medical Devices Issued Emergency Use Authorizations
(EUAs) Related to Coronavirus Disease 2019 (COVID-19)
* Webinar on Guidances on COVID-19 Transition Plans for Medical Devices (April
18, 2023)
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:
* 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
* Amended Determination of a Public Health Emergency or Significant Potential
for a Public Health Emergency Pursuant to Section 564(b) of the FD&C Act
(effective March 15, 2023; Federal Register notice March 20, 2023)
* 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.
IN VITRO DIAGNOSTICS
Please see the page In Vitro Diagnostics EUAs for information about in vitro
diagnostics EUAs, including templates.
For current SARS-CoV-2 in vitro diagnostic EUAs, see:
* Molecular Diagnostic Tests for SARS-CoV-2
* Antigen Diagnostic Tests for SARS-CoV-2
* Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
* IVDs for Management of COVID-19 Patients
On February 29, 2020, the FDA issued an immediately in effect guidance with
policy specific to development of in vitro diagnostic tests during this public
health emergency. This guidance was updated on March 16, 2020, May 4, 2020, and
May 11, 2020. On September 27, 2022, FDA updated this policy to ensure continued
access to tests while encouraging the transition of these important public
health tools to traditional premarket review pathways. The updated policy
describes the FDA’s intent to review only a small subset of new EUA requests for
diagnostic tests and encourages developers of all test types interested in
marketing authorization to pursue authorization through the de novo
classification or 510(k) clearance pre-market review pathways.
CDC has granted a right of reference to the performance data contained in CDC's
EUA (FDA submission number EUA200001) to any entity seeking an FDA EUA for a
COVID-19 diagnostic device.
Templates for these EUA submissions are available to help facilitate the
preparation, submission, and authorization of an EUA.
For additional information, see Policy for Coronavirus Disease-2019 Tests During
the Public Health Emergency (Revised), FAQs on Diagnostic Testing for
SARS-CoV-2, EUA Authorized Serology Test Performance, and CLIA and University
Laboratory Testing FAQ (CMS).
SARS-COV-2 DIAGNOSTIC TESTS FOR COVID-19 THAT HAVE BEEN GRANTED A DE NOVO,
510(K) CLEARANCE OR PMA
For a list of all molecular SARS-CoV-2 diagnostic tests that have been cleared
or granted De Novo classification, see devices with product codes QOF and QQX in
FDA’s medical devices databases for 510(k) and De Novo. For a list of all
antigen SARS-CoV-2 diagnostic tests that have been cleared or granted De Novo
classification, see devices with product code QVF in FDA’s medical devices
databases for 510(k) and De Novo.
* 510(k) Premarket Database
* De Novo Premarket Database
PERSONAL PROTECTIVE EQUIPMENT (PPE)
Please see the page Personal Protective Equipment EUAs for current EUAs.
For additional information, see Recent Final Medical Device Guidance Documents,
and Non-NIOSH Approved Respirator FAQ.
See Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators and Decontamination and Bioburden Reduction Systems below for
information about June 30, 2021 EUA revocations.
OTHER MEDICAL DEVICE EUAS
Please see the following pages for EUA templates and additional information
about other types of medical device EUAs for COVID-19:
* Blood Purification Devices EUAs
* Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
* Infusion Pump EUAs
* Remote or Wearable Patient Monitoring Devices EUAs
* Respiratory Assist Devices EUAs
* Ventilators and Ventilator Accessories EUAs
* Other Medical Device EUAs
REVOKED EUAS FOR NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS
(FFRS) AND DECONTAMINATION AND BIOBURDEN REDUCTION SYSTEMS
On June 30, 2021, the FDA announced the revocation of the following EUAs:
* Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
(effective July 6, 2021)
* Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in
China (effective July 6, 2021)
* Decontamination and Bioburden Reduction System EUAs for Personal Protective
Equipment (effective June 30, 2021)
As of the effective date of the revocations, these devices will no longer be
authorized for use by health care personnel in health care settings.
For additional information, please see Update: FDA No Longer Authorizes Use of
Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health
Care Personnel and Facilities.
Historical information regarding these EUAs can be found on Historical
Information about Device Emergency Use Authorizations and Emergency Use
Authorization--Archived Information.
MEDICAL DEVICE FEDERAL REGISTER NOTICES
* Authorization of Emergency Use of Certain Medical Devices During COVID-19;
Availability (through April 10, 2020)
* Authorization of Emergency Use of Certain Medical Devices During COVID-19;
Availability (April 11, 2020- May 15, 2020)
* Authorization of Emergency Use of Certain Medical Devices During COVID-19;
Availability (May 15, 2020- September 14, 2020)
* Authorization of Emergency Use of Certain Medical Devices During COVID-19;
Availability (September 15, 2020 - February 15, 2021)
* Authorization of Emergency Use of Certain Medical Devices During COVID-19;
Availability (February 16, 2021- May 31, 2021)
* Authorization of Emergency Use of Certain Medical Devices During COVID-19;
Availability (June 1, 2021 - September 10, 2021)
* Emergency Use Authorization: Certain Medical Devices during COVID-19
(September 11, 2021 - January 24, 2022)
* Authorization of Emergency Use of Certain Medical Devices During COVID-19;
Availability (January 25, 2022 - June 15, 2022)
* Emergency Use Authorization: Certain Medical Devices during COVID-19 (June
16, 2022 - December 6, 2022)
* Emergency Use Authorization: Certain Medical Devices during COVID-19
(December 7, 2022 - February 24, 2023)
* Authorization and Revocations of Emergency Use of Certain In Vitro Diagnostic
Devices for Detection and/or Diagnosis of COVID-19; Availability (for one
authorization effective May 28, 2021, and three revocations effective July
19, 2022)
* Revocation notices for device EUAs are available at: Historical Information
about Device Emergency Use Authorizations
back to About EUAs
MPOX EUA INFORMATION
MPOX VACCINE EUAS
On November 28, 2022, the World Health Organization announcedExternal Link
Disclaimer, 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
Search:
Show 102550100All entries
Date of First EUA IssuanceLetter of Authorization (PDF)Authorized UseFact Sheets
and Manufacturer Instructions/Package Insert (PDF)Additional Information and
Decision Memoranda (PDF)Federal Register Notice for EUAAugust 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)
* 中文 (Chinese, Simplified)
* 한국어 (Korean)
* Español (Spanish)
* Tagalog (Tagalog)
* Tiếng Việt (Vietnamese)
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)
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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:
* Policy for Monkeypox Tests to Address the Public Health Emergency
* Monkeypox Emergency Use Authorizations for Medical Devices (including EUA
templates)
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).
Search:
Show 102550100All entries
Date of First EUA IssuanceAdditional InformationFederal Register
NoticesSeptember 7, 2022
* Monkeypox Emergency Use Authorizations for Medical Devices - Including a list
of current medical device EUAs for mpox
* FAQs on Testing for Monkeypox - Answers to frequently asked questions
relating to the development and performance of tests to detect the virus that
causes mpox, primarily intended for test developers
* Monkeypox Update: FDA Takes Significant Action to Help Expand Access to
Testing (September 7, 2022)
* Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection
of Monkeypox Virus; Availability (October 7, 2022)
* Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection
of Monkeypox Virus; Availability (October 27, 2022)
* Authorization of Emergency Use of an In Vitro Diagnostic Device in Response
to an Outbreak of Mpox; Availability (December 30, 2022)
* Emergency Use Authorization: In Vitro Diagnostic Device in Response to an
Outbreak of Mpox (January 11, 2023)
* Emergency Use Authorization: In Vitro Diagnostic Devices in Response to an
Outbreak of Mpox (January 31, 2023)
* Emergency Use Authorization: In Vitro Diagnostic Device in Response to an
Outbreak of Mpox (March 10, 2023)
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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.
back to About EUAs
OTHER CURRENT EUAS
The tables below provide information on current EUAs:
* Anthrax EUAs
* Ebola Virus 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.
back to top of page
ANTHRAX EUAS
The 2016 FDA Doxycycline Emergency Dispensing Order and CDC Doxycycline
Emergency Use Instructions (EUI) together replace the need for the doxycycline
mass dispensing EUA (issued on July 21, 2011). Therefore, the doxycycline
emergency dispensing order and EUI should be used by stakeholders for anthrax
preparedness and response instead of the mass dispensing EUA.
The July 21, 2011, doxycycline mass dispensing EUA, and the October 14, 2011,
National Postal Model anthrax EUA will be terminated by FDA, and notice of such
termination will be published in the Federal Register. For additional
information, see Emergency Use Authorization--Archived Information.
back to list of current EUAs
EBOLA VIRUS EUA INFORMATION
Ebola preparedness and response updates from FDA (all agency activities)
For more information about the diagnostics below, also see Emergency Use
Authorizations for Medical Devices: 2014 Ebola Virus Emergency Use
Authorizations.
EBOLA DIAGNOSTIC TESTS WITH DE NOVO, 510(K) OR PMA
* OraQuickEbola Rapid Antigen Test - On October 10, 2019, FDA allowed marketing
(PDF, 255 KB) of a rapid diagnostic test (RDT) to detect Ebola virus antigens
(proteins) in human blood from certain living individuals and samples from
certain recently deceased individuals suspected to have died from Ebola
(cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first
rapid diagnostic test the FDA has allowed to be marketed in the U.S. for
Ebola virus disease (EVD). The test provides a rapid, presumptive diagnosis
that must be confirmed. Also see the FDA news release: FDA allows marketing
of first rapid diagnostic test for detecting Ebola virus antigens
The OraQuick Ebola Test was reviewed under the De Novo premarket review
pathway, a regulatory pathway for low-to-moderate-risk devices of a new type.
Along with this marketing authorization, the FDA is establishing criteria,
called special controls, that determine the requirements for demonstrating
accuracy, reliability and effectiveness of tests intended to identify Ebola
virus antigens. These special controls, when met along with general controls,
provide a reasonable assurance of safety and effectiveness for tests of this
type. This action also creates a new regulatory classification, which means
that subsequent devices of the same type with the same intended use may go
through the FDA’s 510(k) pathway, whereby devices can obtain clearance by
demonstrating substantial equivalence to a predicate device.
Medical Product Date of EUA Issuance Letter of Authorization Federal Register
Notice for EUA Fact Sheets and Manufacturer Instructions/Package Insert EUA
Determination and Declaration (Effective Date) PREP Act Declaration (if
applicable)
EZ1 Real-time RT-PCR Assay
(DoD)
August 5, 2014 (initial issuance)
October 10, 2014 (reissuance)
Authorization (PDF, 61 KB)
FR notice
* Healthcare (PDF, 58 KB)
* Patients (PDF, 59 KB)
* Instruction Booklet (PDF, 1.1 MB)
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of
Ebola Virus (August 4, 2014)
CDC Ebola Virus NP Real-time RT-PCR Assay
(CDC)
October 10, 2014 (initial issuance)
March 2, 2015 (reissuance)
October 8, 2019 (amended)
Authorization (PDF, 282 KB)
Letter granting EUA amendment(s) (PDF, 134 KB)
FR notice
* Healthcare (PDF, 207 KB)
* Patients (PDF, 149 KB)
* Instructions for Use (PDF, 496 KB)
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of
Ebola Virus (August 4, 2014)
CDC Ebola Virus VP40 Real-time RT-PCR Assay
(CDC)
October 10, 2014 (initial issuance)
March 2, 2015 (reissuance)
October 8, 2019 (amended)
Authorization (PDF, 285 KB)
Letter granting EUA amendment(s) (PDF, 135 KB)
FR notice
* Healthcare (PDF, 207 KB)
* Patients (PDF, 149 KB)
* Instructions for Use (PDF, 494 KB)
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of
Ebola Virus (August 4, 2014)
FilmArray Biothreat-E test
(Biofire Defense, LLC)
October 25, 2014
November 12, 2019 (amended)
Authorization (PDF, 73 KB)
Letter granting EUA amendment(s) (PDF, 152 KB)
FR notice
* Healthcare (PDF, 227 KB)
* Patients (PDF, 191 KB)
* Instructions for Use (PDF, 1.6 MB)
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of
Ebola Virus (August 4, 2014)
RealStar Ebolavirus RT-PCR Kit 1.0
(altona Diagnostics, GmbH)
November 10, 2014 (initial issuance)
November 26, 2014 (reissuance)
Authorization (PDF, 263 KB)
FR notice
* Healthcare (PDF, 81 KB)
* Patients (PDF, 92 KB)
* Instructions for Use (PDF, 797 KB)
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of
Ebola Virus (August 4, 2014)
LightMix Ebola Zaire rRT-PCR Test
(Roche Molecular Systems, Inc.)
December 23, 2014
Authorization (PDF, 2.2 MB)
FR notice
* Healthcare (PDF, 59 KB)
* Patients (PDF, 60 KB)
* Instructions for Use (PDF, 328 KB)
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of
Ebola Virus (August 4, 2014)
Xpert Ebola Assay
(Cepheid)
March 23, 2015
Authorization (PDF, 240 KB)
FR notice
* Healthcare (PDF, 310 KB)
* Patients (PDF, 211 KB)
* Instructions for Use (PDF, 625 KB)
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of
Ebola Virus (August 4, 2014)
DPP Ebola Antigen System (Chembio Diagnostic Systems, Inc.)
November 9, 2018
April 2, 2019 (amended)
Authorization (PDF, 103 KB)
Letter Granting EUA Amendment(s) (PDF, 87 KB)
FR notice
* Healthcare (PDF, 122 KB)
* Patients (PDF, 119 KB)
* Instructions for Use (PDF, 2 MB)
Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of
Ebola Virus (August 4, 2014)
back to list of current EUAs
FREEZE DRIED PLASMA INFORMATION
Also see FDA News Release: FDA takes action to support American military
personnel by granting an authorization for freeze-dried plasma product to enable
broader access while the agency works toward approval of the product (July 10,
2018)
Medical Product Date of EUA Issuance Letter of Authorization Federal Register
Notice for EUA Fact Sheets and Manufacturer Instructions/Package Insert EUA
Determination and Declaration (Effective Date) PREP Act Declaration (if
applicable)
Pathogen-Reduced Leukocyte-Depleted Freeze Dried Plasma (Centre de Transfusion
Sanguine des Armées)
July 9, 2018 (initial issuance)
May 8, 2020 (amendment)
Authorization (PDF, 203 KB)
Letter granting EUA amendments (PDF, 60 KB)
FR notice
* Fact Sheet for U.S. Military Medical Personnel (PDF, 132 KB)
* Fact Sheet for Recipients (PDF, 101 KB)
Determination by DoD (June 7, 2018)
Declaration Regarding Emergency Use of Treatment for Hemorrhage or Coagulopathy
During an Emergency Involving Agents of Military Combat (July 9, 2018)
back to list of current EUAs
H7N9 INFLUENZA EUA INFORMATION
For more information about the diagnostics below, also see Emergency Use
Authorizations for Medical Devices: 2013 H7N9 Influenza Emergency Use
Authorization (Potential Emergency).
Medical Product Date of EUA Issuance Letter of Authorization Federal Register
Notice for EUA Fact Sheet and Manufacturer Instructions/Package Insert EUA
Determination and Declaration (Effective Date) PREP Act Declaration (if
applicable)
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7
(Eurasian Lineage) Assay
April 22, 2013 (initial issuance)
March 27, 2018 (reissuance)
Authorization (PDF, 301 KB), re-issued March 27, 2018
FR notice
* Healthcare (PDF, 46 KB)
* Patients (PDF, 32 KB)
* Instructions for Use (PDF, 433 KB)
Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics
for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013)
Additional information from HHS
Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the
October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008,
declaration and February 29, 2012, declaration is effective as of January 1,
2016.)
Quidel Lyra Influenza A Subtype H7N9 Assay
February 14, 2014
Authorization (PDF, 57 KB)
FR notice
* Healthcare (PDF, 42 KB)
* Patients (PDF, 40 KB)
Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics
for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013)
Additional information from HHS
Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the
October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008,
declaration and February 29, 2012, declaration is effective as of January 1,
2016.)
A/H7N9 Influenza Rapid Test
April 25, 2014
Authorization
FR notice
* Healthcare
* Patients
Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics
for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013)
Additional information from HHS
Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the
October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008,
declaration and February 29, 2012, declaration is effective as of January 1,
2016.)
back to list of current EUAs
MIDDLE EAST RESPIRATORY SYNDROME CORONAVIRUS (MERS-COV) EUA INFORMATION
For more information about the diagnostics below, also see Emergency Use
Authorizations for Medical Devices: 2013 Coronavirus Emergency Use Authorization
(Potential Emergency).
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
* Healthcare
* Patients
* Contacts (PDF, 1.2 MB)
* Instructions for Use (PDF, 743 KB)
Determination and Declaration Regarding Emergency Use of In Vitro Diagnostics
for Detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) (May
29, 2013)
Additional information from HHS
RealStar MERS-CoV RT-PCR Kit U.S.
July 17, 2015
(initial issuance)
February 12, 2016 (reissuance)
Authorization (PDF, 238 KB)
FR notice
* Healthcare (PDF, 269 KB)
* Patients (PDF, 241 KB)
* Instructions for Use (PDF, 1.28 MB)
* Fact Sheet for Asymptomatic Individuals Suspected of Exposure to MERS-CoV
Cases (PDF, 285 KB)
Determination and Declaration Regarding Emergency Use of In Vitro Diagnostics
for Detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) (May
29, 2013)
Additional information from HHS
back to list of current EUAs
NERVE AGENT EUA INFORMATION
On July 9, 2018, FDA approved (PDF, 49 KB) the 2 mg Atropine Auto-Injector
manufactured by Rafa Laboratories, Ltd., for the treatment of poisoning by
susceptible organophosphorous nerve agents having cholinesterase activity as
well as organophosphorous or carbamate insecticides in adults and pediatric
patients weighing over 90 lbs [41 kg] (generally over 10 years of age). For more
information about the approved 2 mg Rafa Atropine Auto-Injector, see the product
label (PDF, 482 KB). The EUA detailed in the table below is still in effect.
Medical Product Date of EUA Issuance Letter of Authorization Federal Register
Notice for EUA Fact Sheets and Manufacturer Instructions/Package Insert EUA
Determination and Declaration (Effective Date) PREP Act Declaration (if
applicable)
Atropine Auto-Injector (Rafa Laboratories Ltd.)
April 11, 2017 (initial issuance)
May 23, 2017 (amended)
January 24, 2018 (amended)
March 6, 2018 (amended)
May 15, 2018 (amended)
Letter of Authorization (PDF, 514 KB)
Letter granting EUA amendment(s) (PDF, 28 KB)
2nd letter granting EUA amendment(s) (PDF, 33 KB)
3rd letter granting EUA amendment(s) (PDF, 85 KB)
4th letter granting EUA amendment(s) (PDF, 42 KB)
FR
notice
* Healthcare (PDF, 531 KB)
* Patients and Caregivers (PDF, 675 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)
back to list of current EUAs
ZIKA VIRUS EUA INFORMATION
Zika virus response updates from FDA
Zika virus diagnostic development information
For more information about the diagnostics below, also see Emergency Use
Authorizations for Medical Devices: Zika Virus Emergency Use Authorization.
Draft EUA review templates for Zika are available by email request to:
CDRH-ZIKA-Templates@fda.hhs.gov
Laboratory personnel using Zika diagnostic assays under EUA are encouraged to
report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov,
in addition to reporting concerns to the manufacturer.
ZIKA DIAGNOSTIC TESTS WITH DE NOVO, 510(K), OR PMA
* ZIKV Detect 2.0 IgM Capture ELISA - On May 23, 2019, FDA authorized marketing
(PDF, 175 KB) of the ZIKV Detect 2.0 IgM Capture ELISA to detect Zika virus
immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM
Capture ELISA is the first Zika diagnostic test the FDA has allowed to be
marketed in the U.S.; previously, tests for detecting Zika virus IgM
antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—had been
authorized only for emergency use under the FDA’s EUA authority. Also see the
FDA news release: FDA authorizes marketing of first diagnostic test for
detecting Zika virus antibodies
* ADVIA Centaur Zika test – On July 17, 2019, FDA cleared the ADVIA Centaur
Zika test. This is the second Zika diagnostic test FDA has allowed to be
marketed in the U.S. for detecting Zika virus IgM antibodies. Previously, the
test had been authorized only for emergency use under FDA’s EUA authority.
* LIAISON XL Zika Capture IgM Assay II – On October 28, 2019, FDA cleared the
LIAISON XL Zika Capture IgM Assay II for detecting Zika virus IgM antibodies.
Previously, the test had been authorized only for emergency use under FDA’s
EUA authority.
* DPP Zika IgM Assay System – On June 3, 2020, FDA cleared a similar DPP Zika
IgM System for detecting Zika virus IgM antibodies. Previously, the test had
been authorized only for emergency use under FDA’s EUA authority.
Medical Product Date of EUA Issuance Letters Federal Register Notice for EUA
Fact Sheets and Manufacturer Instructions/Package Insert
EUA Determination and Declaration (Effective Date) PREP Act Declaration (if
applicable)
CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent
Assay
CDC statement on this EUA
February 26, 2016 (initial issuance)
June 29, 2016 (amended)
November 15, 2016 (amended)
December 6, 2016 (amended)
May 3, 2017 (amended)
July 31, 2017 (amended)
April 16, 2018 (amended)
September 26, 2018 (amended)
Letter granting EUA amendment(s) (PDF, 155 KB)
Letter granting EUA amendment(s) (PDF, 123 KB)
Letter granting EUA amendment(s) (PDF, 110 KB)
Letter granting EUA amendment(s) (PDF, 113 KB)
Letter granting EUA amendment(s) (PDF, 131 KB)
Letter granting EUA amendment(s) (PDF, 131 KB)
FR notice
* Healthcare (PDF, 83 KB)
* Patients (PDF, 220 KB)
* Instructions for Use (PDF, 5.5 MB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR)
CDC statement on this EUA
March 17, 2016 (initial issuance)
September 21, 2016 (amended)
January 12, 2017 (amended)
February 28, 2017 (amended)
April 6, 2017 (amended)
February 26, 2021 (amended)
Authorization (PDF, 82 KB)
Letter granting EUA amendment(s) (PDF, 223 KB)
Letter granting EUA amendment(s) (PDF, 223 KB)
Letter granting EUA amendment(s) (PDF, 223 KB)
Letter granting EUA amendment(s) (PDF, 126 KB)
Letter granting EUA amendment(s) (PDF, 143 KB)
FR notice
* Healthcare (PDF, 224 KB)
* Patients (PDF, 200 KB)
* Instructions for Use (PDF, 1.45MB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
Zika Virus RNA Qualitative Real-Time RT-PCR (Quest Diagnostics Infectious
Disease, Inc.)
April 28, 2016 (initial issuance)
October 7, 2016 (reissuance)
April 11, 2017 (amended)
Authorization (PDF, 339 KB)
Letter granting EUA amendment(s) (PDF, 126 KB)
FR notice
* Healthcare (PDF, 53 KB)
* Patients (PDF, 27 KB)
* Instructions for Use (PDF, 439 KB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
RealStar Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH)
May 13, 2016 (initial issuance)
October 31, 2016 (amended)
March 6, 2017 (amended)
Authorization (PDF, 342 KB)
Letter Granting EUA Amendment(s) (PDF, 130 KB)
Letter Granting EUA Amendment(s) (PDF, 130 KB)
FR notice
* Healthcare (PDF, 232 KB)
* Patients (PDF, 213 KB)
* Instructions for Use (PDF, 809 KB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
Aptima Zika Virus assay (Hologic, Inc.)
June 17, 2016 (initial issuance)
September 7, 2016 (amended)
April 12, 2017 (amended)
March 8, 2018 (amended)
Authorization (PDF, 305 KB)
Letter granting EUA amendment(s) (PDF, 126 KB)
Letter granting EUA amendment(s) (PDF, 124 KB)
Letter granting EUA amendment(s) (PDF, 130 KB)
FR notice
* Healthcare (PDF, 208 KB)
* Patients (PDF, 190 KB)
* Instructions for Use (PDF, 276 KB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
Zika Virus Real-time RT-PCR Test (Viracor Eurofins)
July 19, 2016 (initial issuance)
February 28, 2017 (amended)
Authorization (PDF, 334 KB)
Letter granting EUA amendment(s) (PDF, 124 KB)
FR notice
* Healthcare (PDF, 229 KB)
* Patients (PDF, 188 KB)
* Instructions for Use (PDF, 623 KB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
VERSANT Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics Inc.)
July 29, 2016 (initial issuance)
December 19, 2016 (amended)
Authorization (PDF, 78 KB)
Letter granting EUA amendment(s) (PDF, 124 KB)
FR notice
* Healthcare (PDF, 170 KB)
* Patients (PDF, 133 KB)
* Instructions for Use (PDF, 511 KB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
Sentosa SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.)
September 23, 2016
Authorization (PDF, 355 KB)
FR notice
* Healthcare (PDF, 270 KB)
* Patients (PDF, 236 KB)
* Instructions for Use (PDF, 1.9 MB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
Zika Virus Detection by RT-PCR Test (ARUP Laboratories)
September 28, 2016
Authorization (PDF, 98 KB)
FR notice
* Healthcare (PDF, 52 KB)
* Patients (PDF, 200 KB)
* Instructions for Use (PDF, 505 KB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
Abbott RealTime ZIKA (Abbott Molecular Inc.)
November 21, 2016 (initial issuance)
January 6, 2017 (amended)
Authorization (PDF, 84 KB)
Letter granting EUA amendment(s) (PDF, 150 KB)
FR notice
* Healthcare (PDF, 208 KB)
* Patients (PDF, 217 KB)
* Instructions for Use (PDF, 1.2 MB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)
December 9, 2016
Authorization (PDF, 312 KB)
FR notice
* Healthcare (PDF, 213 KB)
* Patients (PDF, 179 KB)
* Instructions for Use (PDF, 718 KB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
Gene-RADAR Zika Virus Test (Nanobiosym Diagnostics, Inc.)
March 20, 2017
Authorization (PDF, 313 KB)
FR notice
* Healthcare (PDF, 267 KB)
* Patients (PDF, 240 KB)
* Instructions for Use (PDF, 338 KB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
TaqPath Zika Virus Kit (Thermo Fisher Scientific)
August 2, 2017
Authorization (PDF, 292 KB)
FR notice
* Healthcare (PDF, 252 KB)
* Patients (PDF, 180 KB)
* Instructions for Use (PDF, 756 KB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
CII-ArboViroPlex rRT-PCR Assay (Columbia University)
August 11, 2017
Authorization (PDF, 377 KB)
FR notice
* Healthcare (PDF, 229 KB)
* Patients (PDF, 176 KB)
* Instructions for Use (PDF, 657 KB)
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or
Diagnosis of Zika Virus Infection (February 26, 2016)
back to list of current EUAs
RELATED LINKS
* Coronavirus Disease 2019 (COVID-19)
* Summary of Process for EUA Issuance
* Current Emergency Use Authorizations for Medical Devices
* FAQs: What happens to EUAs when a public health emergency ends?
* How to Submit a Pre-EUA for In vitro Diagnostics (IVDs) to FDA (for test
manufacturers)
* Information for Laboratories Implementing IVD Tests Under EUA
* Process for Publishing Emergency Use Authorizations for Medical Devices
During Coronavirus Disease 2019 (June 2, 2020)
* 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 Preparedness and Response Updates from FDA
* Zika Virus Response Updates from FDA
* Historical Information about Device Emergency Use Authorizations
CONTENT CURRENT AS OF:
03/31/2023
*
* MCM Legal, Regulatory and Policy Framework
* Emergency Use Authorization
* Expiration Dating Extension
* MCM Emergency Use Authorities
* MCM-Related Counterterrorism Legislation
* MCM-Related Legal and Policy Presentations, Publications and Q&As
* State, Tribal, Local, and Territorial Public Health Preparedness
* Guidance and Other Information of Special Interest to MCM Stakeholders
* MCM-Related Cooperative Arrangements
* Availability of Regulatory Management Plans
* Vaccine EUA Questions and Answers for Stakeholders
* FAQs: What happens to EUAs when a public health emergency ends?
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