What does you mean by authorization revoked?

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

• Coronavirus Disease (COVID-19) updates from FDA
• Detailed Information for all COVID-19 EUAs, including authorizations and fact sheets
  • Vaccines
  • 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)
• 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

Federal Register notices:

• Authorizations of Emergency Use of Two Biological Products During the COVID-19 Pandemic; Availability
  • On December 11, 2020, FDA issued an EUA to Pfizer, Inc. for the Pfizer-BioNTech COVID-19 Vaccine, subject to the terms of the Authorization. On December 18, 2020, FDA issued an EUA to ModernaTX, Inc. for the Moderna COVID-19 Vaccine, subject to the terms of the Authorization.
• Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability (May 27, 2021)
  • On February 27, 2021, FDA issued an EUA to Janssen Biotech, Inc. for the Janssen COVID-19 Vaccine, subject to the terms of the authorization.

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)

Healthcare Providers (1.49MB, updated October 19, 2022)

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

Janssen COVID-19 Vaccine (299KB) (Reissued June 10, October 20 and November 19, 2021, and May 5, 2022)

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)

Healthcare Providers (715 KB)

Recipients and Caregivers (362 KB)

• View the Fact Sheet for Recipients and Caregivers in multiple additional languages

More information about the Janssen COVID-19 Vaccine

Frequently Asked Questions on 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)

• Federal Register notice, May 27, 2021

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 October 25, 2022)

More information about the Moderna COVID-19 Vaccine

Frequently Asked Questions on 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

Pfizer-BioNTech COVID-19 Vaccine (1.5MB) (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, and December 8 2022)

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)

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 (2.76MB, updated December 8, 2022) –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 (2.62MB, updated November 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 (632KB, updated December 8, 2022) –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 (596KB, November 15, 2022)

More information about the Pfizer-BioNTech COVID-19 Vaccine

Frequently Asked Questions on 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)

• Federal Register notice, January 19, 2021

Drugs and Non-Vaccine Biological 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.

• 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)
• 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.

Federal Register notices:

• Authorizations and Revocation of Emergency Use of Drugs During the COVID-19 Pandemic; Availability (September 11, 2020)
  • FDA announced issuance of four authorizations for the emergency use of drugs during the COVID-19 pandemic and one revocation. On March 28, 2020, FDA issued an EUA to BARDA for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate, subject to the terms of the Authorization. On April 30, 2020, FDA issued an EUA to Fresenius Medical Care for multiFiltrate PRO System and multiBic/multiPlus Solutions, subject to the terms of the authorization. On May 1, 2020, FDA issued an EUA to Gilead Sciences, Inc. for remdesivir, subject to the terms of the authorization. On May 8, 2020, FDA issued an EUA to Fresenius Kabi USA, LLC for Fresenius Propoven 2% Emulsion, subject to the terms of the authorization. FDA revoked the EUA for BARDA's oral formulations of chloroquine phosphate and hydroxychloroquine sulfate on March 28, 2020.
• Authorizations of Emergency Use of Certain Drug and Biological Products During the COVID-19 Pandemic; Availability (February 19, 2021)
  • FDA announced issuance of five authorizations for the emergency use of drug and biological products during the COVID-19 pandemic. On August 13, 2020, FDA issued an EUA to Baxter for REGIOCIT, subject to the terms of the authorization. On August 23, 2020, FDA issued an EUA to ASPR/HHS for COVID-19 convalescent plasma, subject to the terms of the authorization. On November 9, 2020, FDA issued an EUA to Eli Lilly and Company for bamlanivimab, subject to the terms of the authorization (technical correction on November 10, 2020). On November 19, 2020, FDA issued an EUA to Eli Lilly and Company for OLUMIANT (baricitinib), for use in combination with VEKLURY (remdesivir), subject to the terms of the authorization. On November 21, 2020, FDA issued an EUA to Regeneron Pharmaceuticals, Inc. for casirivimab and imdevimab, administered together, subject to the terms of the authorization.
• Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability (May 27, 2021)
  • On February 9, 2021, FDA issued an EUA to Eli Lilly and Company for bamlanivimab and etesevimab, administered together, subject to the terms of the authorization
• Authorization and Revocation of Emergency Use of Drugs During the COVID-19 Pandemic; Availability (June 23, 2021)
  • FDA announced the issuance of an EUA for a drug for use during the COVID-19 pandemic. FDA issued the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by B. Braun Melsungen AG. The authorization contains, among other things, conditions on the emergency use of the authorized drug. FDA also annouced the revocation of the authorization issued to Eli Lilly and Company for bamlanivimab alone. FDA revoked this authorization on April 16, 2021. Reprinted in this document is the issuance of the Authorization and the revocation, which include an explanation of the reasons for issuance or revocation.
• Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability (August 5, 2021)
  • FDA announced the issuance of two authorizations for biological products for use during the COVID-19 pandemic. On May 26, 2021, FDA issued an EUA to GlaxoSmithKline LLC for sotrovimab, subject to the terms of the authorization.  On June 24, 2021, FDA issued an EUA to Genentech, Inc. for ACTEMRA (tocilizumab), subject to the terms of the authorization.
• Authorizations of Emergency Use of Certain Drugs and Biological Products During the COVID-19 Pandemic; Availability (February 4, 2022)
  • FDA announced the issuance of three EUAs for use during the COVID-19 pandemic. FDA issued one authorization for a biological product as requested by AstraZeneca Pharmaceuticals LP (AZ) (December 8, 2021), one authorization for a drug product as requested by Pfizer, Inc. (Pfizer) (December 22, 2021), and one authorization for a drug product as requested by Merck Sharp & Dohme Corp. (Merck) (December 23, 2021).
• Emergency Use Authorization: Biological Product during the COVID-19 Pandemic (March 22, 2022)
  • FDA announced the issuance of one EUA for a biological product for use during the COVID-19 pandemic. On February 11, 2022, FDA issued an EUA to Eli Lilly and Company (Lilly) for the biological product bebtelovimab, subject to the terms of the authorization
• Revocation notices for COVID-19 drug and biological product EUAs are available at: Emergency Use Authorization--Archived Information

Office of the Assistant Secretary for Preparedness and Response (ASPR) Important Updates: COVID-19 Therapeutics

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

Date of First EUA IssuanceMost Recent Letter of Authorization (PDF)Authorized Use 1Fact Sheets and Manufacturer Instructions/ Package Insert (PDF)Federal Register Notice for EUA11/08/2022Kineret (256KB)Kineret (anakinra) is authorized for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR).

Healthcare Providers (656KB)

Patients and Caregivers (413KB)

Frequently Asked Questions on the Emergency Use Authorization of Kineret (175KB)

Bebtelovimab (460KB) (reissued August 5 and October 27, 2022)

Letter Granting EUA Amendment (March 30, 2022) (216KB)

Letter Granting EUA Amendment (September 16, 2022) (194KB)

Letter Granting EUA Amendment (November 4, 2022) (310KB)

FDA Updates on Bebtelovimab (November 4, 2022)

ASPR and FDA Statement on Shelf-Life Extension of Bebtelovimab (October 28, 2022) 

Bebtelovimab is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency.

Bebtelovimab is authorized 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 who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

Healthcare Providers (763KB) (updated November 4, 2022)

Patients, Parents, and Caregivers (245KB)(updated November 4, 2022)

• Spanish (141KB)

Frequently Asked Questions on the Emergency Use Authorization of Bebtelovimab (1.01MB)

CDER Scientific Review Documents Supporting EUA

• Federal Register notice, March 22, 2022

Lagevrio (molnupiravir) (696KB) (reissued August 5 and October 27, 2022)

ASPR and FDA Statement on Shelf-Life Extension Evaluation of Lagevrio (October 21, 2022)

Healthcare Providers (1.5MB) (updated August 26, 2022)

• Spanish (1.38MB)

Patients, Parents, and Caregivers (131KB)

• Spanish (350KB)

COVID-19 Test to Treat locator (Find a treatment location near you, from ASPR)

Dear Healthcare Provider Letter (268KB)

Frequently Asked Questions on the Emergency Use Authorization of Lagevrio (1.01MB)

Prescriber Checklist for Lagevrio (180KB)

CDER Scientific Review Documents Supporting EUA

• Federal Register notice, February 4, 2022

Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) (696KB) (reissued March 17, 2022, April 14, 2022, July 6, 2022, August 5, 2022, and October 27, 2022)

Letter Granting EUA Amendment (March 18, 2022) (161KB)

Letter Granting EUA Amendment (September 26, 2022) (255KB)

FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations (July 6, 2022)

ASPR and FDA Statement on Shelf-Life Extension of Paxlovid (September 6, 2022)

Healthcare Providers (1.89MB) (updated September 26, 2022)

Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool (1.27MB) (updated August 26, 2022)

Patients, Parents, and Caregivers (1.11MB) (updated September 26, 2022)

• Spanish (166KB)

COVID-19 Test to Treat locator (Find a treatment location near you, from ASPR)

Dear Healthcare Provider Letter (593KB) (updated August 5, 2022)

Important Dispensing Information for Patients with Moderate Renal Impairment (476KB)

Frequently Asked Questions on the Emergency Use Authorization for Paxlovid (994KB) (updated July 6, 2022)

CDER Conversation on Paxlovid for Health Care Providers

CDER Scientific Review Documents Supporting EUA

• Federal Register notice, February 4, 2022

Evusheld (tixagevimab co-packaged with cilgavimab) (794KB) (reissued December 20, 2021, February 24, 2022, May 17, 2022, October 27, and December 8, 2022)

FDA releases important information about risk of COVID-19 due to variants not neutralized by Evusheld (October 3, 2022)

ASPR and FDA Statement on Shelf-Life Extension of Evusheld (December 5, 2022)

Letter Granting EUA Amendment (June 29, 2022) (168KB)

Letter Granting EUA Amendment (November 18, 2022) (197KB)

• Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and
  • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or
  • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).

Healthcare Providers (1.24MB) (updated November 18, 2022)

• Spanish (691KB) (updated November 18, 2022)

Patients, Parents, and Caregivers (171KB) (updated October 3, 2022)

• Spanish (342KB) (updated October 3, 2022)

Dear Healthcare Provider Letter (439KB) (June 29, 2022)
New Repeat Dosage Recommendations

• Spanish (207KB) (June 29, 2022)

Dear Healthcare Provider Letter (196KB) (October 3, 2022) Updated EVUSHELD EUA Warnings and Precautions

• Spanish (278KB) (October 3, 2022)

Dear Healthcare Provider Letter (226KB) (May 17, 2022)
Addition of EVUSHELD EUA Warning and Precaution for Risk of Cross-Hypersensitivity with COVID-19 Vaccines

Dear Healthcare Provider Letter (144KB) (March 22, 2022) 
Updated EVUSHELD EUA Dosage Recommendations for Patients Who Received an Initial Dose of 150 mg tixagevimab and 150 mg cilgavimab

• Spanish (227KB) (April 1, 2022)

Frequently Asked Questions on the Emergency Use Authorization for Evusheld (942KB) (updated October 20, 2022)

CDER Scientific Review Documents Supporting EUA

• Federal Register notice, February 4, 2022

Healthcare Providers (231KB)

Patients, Parents, and Caregivers (47KB)

Frequently Asked Questions on the Emergency Use Authorization of Actemra (Tocilizumab) (128KB)

CDER Scientific Review Documents Supporting EUA

• Federal Register notice, August 5, 2021

Sotrovimab (375KB) (reissued October 8, 2021, December 16, 2021 and February 23, 2022)

Letter Granting EUA Amendment (December 22, 2021) (161KB)

ASPR and FDA Statement on Shelf-Life Extension of Sotrovimab (August 3, 2022)

Important updates about sotrovimab (ASPR)

Sotrovimab is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to sotrovimab. Therefore, sotrovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency.

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 (1.38MB) (updated March 25, 2022)

• Spanish (295KB, March 25, 2022)

Patients, Parents, and Caregivers (385KB) (updated March 25, 2022)

• Spanish (174KB, March 25, 2022)

Frequently Asked Questions on the Emergency Use Authorization of Sotrovimab (257KB) (updated March 25, 2022)

CDER Scientific Review Documents Supporting EUA

• Federal Register notice, August 5, 2021

Propofol‐Lipuro 1% (344KB)

Letter Granting EUA Amendment (December 16, 2021) (188KB)

Healthcare Providers (446KB)

Patients, Parents, and Caregivers (190KB)

• Federal Register notice, June 23, 2021

Bamlanivimab and Etesevimab (900KB) (Reissued February 25, 2021, August 27, 2021, September 16, 2021, December 3, 2021, December 22, 2021 and January 24, 2022)

ASPR and FDA Statement on Shelf-Life Extension of Bamlanivimab and Etesevimab (May 4, 2022)

Important updates about bamlanivimab/etesevimab (ASPR)

Bamlanivimab and etesevimab are not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bamlanivimab and etesevimab. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency.

Bamlanivimab and etesevimab administered together for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 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 (1.75MB) (updated January 24, 2022)

Patients, Parents, and Caregivers (157KB) (updated December 3, 2021)

• Spanish (158KB) (updated September 16, 2021)

Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab and Etesevimab (312KB) (updated January 31, 2022)

CDER Scientific Review Documents Supporting EUA

• Federal Register notice, February 19, 2021

REGEN-COV (Casirivimab and Imdevimab) (1.03MB) (Reissued February 3, 2021, February 25, 2021, June 3, 2021, July 30, 2021, September 9, 2021, November 17, 2021 and January 24, 2022)

ASPR and FDA Statement on Shelf-Life Extension of REGEN-COV (June 27, 2022)

REGEN-COV (casirivimab and imdevimab) is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to REGEN-COV. Therefore, REGEN-COV may not be administered for treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency.

Casirivimab and imdevimab to be administered together 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 (1.74MB) (updated January 24, 2022)

• Spanish (1.03MB)

Patients, Parents, and Caregivers (147KB) (updated July 30, 2021)

• Spanish (247KB)

Dear Healthcare Provider Letter (435KB) (updated September 16, 2021)

Statement on Post-Exposure Prophylaxis (July 30, 2021)

Frequently Asked Questions on the Emergency Use Authorization of REGEN-COV (Casirivimab and Imdevimab) (311KB) (updated January 31, 2022)

CDER Scientific Review Documents Supporting EUA

Quick Reference Guide for Co-Packaged REGEN-COV (38KB) (September 16, 2021)

• Federal Register notice, February 19, 2021

For emergency use by healthcare providers for the treatment COVID-19 in hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

On May 10, 2022, Olumiant was approved for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
 

Healthcare Providers (Updated May 10, 2022) (272KB)

Patients, Parents, and Caregivers (Updated May 10, 2022) (128KB)

Frequently Asked Questions on the Emergency Use Authorization for Olumiant (baricitinib) for Treatment COVID-19 (270KB) (Updated May 10, 2022)

CDER Scientific Review Documents Supporting EUA

• Federal Register notice, February 19, 2021

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)

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

• Federal Register notice, February 19, 2021

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)

• Federal Register notice, September 11, 2020

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 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.

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).

Molecular SARS-CoV-2 Diagnostic Tests for COVID-19 that have been granted a De Novo, 510(k) clearance or PMA

BioFire Respiratory Panel 2.1 (RP2.1) - On March 17, 2021, FDA granted the first marketing authorization using the De Novo review pathway for the BioFire Respiratory Panel 2.1 (RP2.1) (PDF, 630 KB). The BioFire RP2.1 is for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19. Also see the FDA news release: FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process. With granting of the De Novo for the BioFire RP2.1, the FDA revoked the EUA for this device, which was initially authorized for emergency use in May 2020.

The BioFire Respiratory Panel 2.1 (RP2.1) 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 De Novo authorization, the FDA is establishing criteria, called special controls, that define the requirements related to labeling and performance testing. When met, the special controls, in combination 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.

BioFire COVID-19 Test 2 - On November 1, 2021, FDA cleared the first 510(k) for a COVID-19 test, the BioFire COVID-19 Test 2 from BioFire Defense, LLC. The test, which has been offered under an EUA since March 2020, is the second SARS-CoV-2 diagnostic test granted marketing authorization that permits the test to be marketed beyond the public health emergency. The BioFire COVID-19 Test 2 is a molecular diagnostic test that detects SARS-CoV-2 in nasopharyngeal swab samples (where the sample is taken from deep inside the nose, reaching the back of the throat), in people with symptoms who are suspected of COVID-19 by their health care provider. 

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)
• 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 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 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)

Federal Register notice (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:

• 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). 

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)

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
• 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.

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.

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.

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 Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)