Emergency Use Authorization
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.
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
- Drug and Biological Therapeutic 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
- 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.
| Date of First EUA Issuance | Most Recent Letter of Authorization (PDF) | Authorized Use | Fact Sheets and Manufacturer Instructions/Package Insert (PDF) | Additional Information and Decision Memoranda (PDF) | Federal Register Notice for EUA |
|---|---|---|---|---|---|
| 02/27/2021 |
Janssen COVID-19 Vaccine (439KB) (Reissued June 10, October 20 and November 19, 2021) Letter Granting EUA Amendment (March 29, 2021) (152KB) Letter Granting EUA Amendment (April 23, 2021) (229KB) Concurrence Letter (June 10, 2021) (26KB) Concurrence Letter (June 15, 2021) (57KB) 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) |
For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older |
Healthcare Providers (544KB) Recipients and Caregivers (278KB) |
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) |
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| 12/18/2020 |
Moderna COVID-19 Vaccine (430KB) (Reissued February 25, July 7, August 12, October 20 and November 19, 2021) Letter Granting EUA Amendment (April 1, 2021) (193KB) |
For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older |
Healthcare Providers (609KB)
Recipients and Caregivers (256KB) |
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) |
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| 12/11/2020 |
Pfizer-BioNTech COVID-19 Vaccine (481KB) (Reissued February 25, May 10, June 25, August 12, August 23, September 22, October 20, 2021, October 20, 2021 and November 19, 2021) Letter Granting EUA Amendment (January 6, 2021) (164KB) Letter Granting EUA Amendment (January 22, 2021) (190KB) Letter Granting EUA Amendment (April 6, 2021) (166KB) Letter Granting EUA Amendment (May 19, 2021) (184KB) Concurrence Letter (August 22, 2021) (68KB) |
For the prevention of 2019 coronavirus disease (COVID-19) in people 5 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 (1.33MB) – for 12 years of age and older, purple cap (must dilute) Healthcare Providers (1.08MB) – for 12 years of age and older, gray cap (no dilution) - This formulation is not yet available in the United States. Healthcare Providers (1.32MB) – for 5-11 years of age, orange cap (must dilute) Recipients and Caregivers (212KB) –12 years of age and older Recipients and Caregivers (221KB) – 5-11 years of age |
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) |
Drug and Biological Therapeutic Products
The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.
- 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)
Related information: FDA Combating COVID-19 With Therapeutics (PDF, 610 KB)
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.
- Authorizations and Revocation of Emergency Use of Drugs During the COVID-19 Pandemic; Availability
- 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
- 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.
- Authorization and Revocation of Emergency Use of Drugs During the COVID-19 Pandemic; Availability
- 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
- 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.
| Date of First EUA Issuance | Most Recent Letter of Authorization (PDF) | Authorized Use 1 | Fact Sheets and Manufacturer Instructions/ Package Insert (PDF) | Federal Register Notice for EUA |
|---|---|---|---|---|
| 06/24/2021 | Actemra (Tocilizumab) (107KB) | For the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). |
Healthcare Providers (231KB) Patients, Parents, and Caregivers (47KB) Frequently Asked Questions on the Emergency Use Authorization of Actemra (Tocilizumab) (128KB) |
None currently |
| 05/26/2021 |
Sotrovimab (498KB) (reissued October 8, 2021) |
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 (424KB) (updated November 3, 2021) Patients, Parents, and Caregivers (134KB) (updated November 3, 2021) Frequently Asked Questions on the Emergency Use Authorization of Sotrovimab (288KB) (updated October 19, 2021) |
None currently |
| 03/12/2021 | Propofol‐Lipuro 1% (344KB) | To maintain sedation via continuous infusion in patients greater than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting. 2 |
Healthcare Providers (420KB) |
None currently |
| 02/09/2021 |
Bamlanivimab and Etesevimab (488KB) (Reissued February 25, 2021, August 27, 2021 and September 16, 2021) Bamlanivimab and Etesevimab Authorized States, Territories, and US Jurisdictions (116KB) (November 17, 2021) |
Bamlanivimab and etesevimab 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 (737KB) (updated September 16, 2021) Patients, Parents, and Caregivers (157KB) (updated September 16, 2021)
Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab and Etesevimab (342KB) (updated October 19, 2021) ASPR and FDA notices about bamlanivimab/etesevimab Shelf-life Extension under EUA
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None currently |
| 11/21/2020 | REGEN-COV (Casirivimab and Imdevimab) (428KB) (Reissued February 3, 2021, February 25, 2021, June 3, 2021, July 30, 2021, September 9, 2021 and November 17, 2021) |
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 (741KB) (updated November 17, 2021)
Patients, Parents, and Caregivers (147KB) (updated July 30, 2021)
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 October 19, 2021) CDER Scientific Review Documents Supporting EUA Quick Reference Guide for Co-Packaged REGEN-COV (38KB) (September 16, 2021) |
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| 11/19/2020 | Baricitinib (Olumiant) (Revised July 28, 2021) | For emergency use by healthcare providers for the treatment COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). |
Healthcare Providers (Updated October 20, 2021)(155KB) Patients, Parents, and Caregivers (Updated July 28, 2021) (55KB) Frequently Asked Questions on the Emergency Use Authorization for Olumiant (baricitinib) for Treatment COVID-19 (270KB) (Updated July 28, 2021) |
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| 08/23/2020 |
COVID-19 convalescent plasma (285KB) (Reissued February 23, 2021 and March 9, 2021) Letter Granting EUA Amendment (June 2, 2021) (107KB) |
For the treatment of hospitalized patients with Coronavirus Disease 2019 (COVID-19) |
Healthcare Providers (176KB) Patients and Parents/ Caregivers (124KB) Decision Memorandum (166KB) |
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| 08/13/2020 | REGIOCIT replacement solution that contains citrate for regional citrate anticoagulation (RCA) of the extracorporeal circuit (92KB) | To be used as a replacement solution only in adult patients treated with continuous renal replacement therapy (CRRT), and for whom regional citrate anticoagulation is appropriate, in a critical care setting | Healthcare Providers (108KB) Patients and Caregivers (52KB) REGIOCIT package insert for EUA (140KB) |
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| 05/08/2020 | Fresenius Kabi Propoven 2% (209KB) | To maintain sedation via continuous infusion in patients older than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting 2 | Healthcare Providers (288KB) Patients and Parent/Caregivers (39KB) Propoven 2% Wall Chart (2.4MB) |
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| 05/01/2020 | Remdesivir for Certain Hospitalized COVID-19 Patients (423KB) (Reissued August 28, 2020, October 1, 2020, and October 22, 2020) |
For emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. On October 22, 2020, FDA approved Veklury (remdesivir) for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the EUA for Veklury continues to authorize Veklury for emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. For additional information, also see: FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—The Science of Safety and Effectiveness |
Healthcare Providers (375KB) Patients and Parent/ Caregivers (94KB)
Frequently Asked Questions on the EUA for Veklury (remdesivir) for Certain Hospitalized Patients (194KB) (Updated February 4, 2021)
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| 04/30/2020 | Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions (171KB) 3 [also listed under Medical Device EUAs] |
To provide continuous renal replacement therapy (CRRT) to treat patients in an acute care environment during the COVID-19 pandemic. |
Healthcare Providers (135KB) Patients (125KB) Instructions for Use, Bloodline/ Tubing (83KB) Instructions for Use, UltraFlux (147KB) Instructions for Use, multiFiltratePRO (15.07MB) Summary of Product Characteristics (SmPC) (308KB) Instructions for Use, MultiPlus (110KB) |
1 The virus that causes COVID-19 has led to an increased number of patients requiring critical care, such as with severe respiratory illness. As a result, there is a shortage of adequate, FDA-approved drugs used for their treatment, such as propofol for sedation of mechanically ventilated patients.
2 In the circumstances of this public health emergency, it would not be feasible to require healthcare providers to seek to limit Fresenius Propoven 2% Emulsion or Propofol-Lipuro 1% only to be used for patients with suspected or confirmed COVID-19; therefore, this authorization does not limit use to such patients.
3 The multiBic/multiPlus Solutions include multiBic dialysate and replacement fluid and multiPlus dialysate. The multiBic replacement fluid is regulated as a drug by CDER. The multiFiltrate PRO System, multiBic dialysate and the multiPlus dialysate solutions are regulated as devices by CDRH.
Information About COVID-19 EUAs for Medical Devices
Information about COVID-19 EUAs for medical devices can be found below and at: Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.
On February 4, 2020, the Secretary determined pursuant to section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV).
On the basis of this determination, the HHS Secretary issued three declarations related to medical devices:
- Determination of Public Health Emergency (effective February 4, 2020), and declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19
- Emergency Use Declaration (effective March 2, 2020), that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak
- Emergency Use Authorization Declaration (effective March 24, 2020), that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak
For identification of the applicable declaration for each EUA, please see each EUA letter of authorization and/or the corresponding Federal Register notice.
Related information: FDA Combating COVID-19 With Medical Devices (PDF, 708 KB)
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.
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 FAQs on Diagnostic Testing for SARS-CoV-2, EUA Authorized Serology Test Performance, and CLIA and University Laboratory Testing FAQ (CMS).
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.
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.
Please see the following pages for EUA templates and additional information about other types of medical device EUAs for COVID-19:
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.
- 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)
- Revocation notices for EUAs are made available on the EUA archive page
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.
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.
Ebola preparedness and response updates from FDA (all agency activities)
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
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) |
|---|---|---|---|---|---|---|
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EZ1 Real-time RT-PCR Assay |
August 5, 2014 (initial issuance) October 10, 2014 (reissuance)
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Authorization (PDF, 61 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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CDC Ebola Virus NP Real-time RT-PCR Assay |
October 10, 2014 (initial issuance) March 2, 2015 (reissuance) October 8, 2019 (amended)
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Authorization (PDF, 282 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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CDC Ebola Virus VP40 Real-time RT-PCR Assay |
October 10, 2014 (initial issuance) March 2, 2015 (reissuance) October 8, 2019 (amended)
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Authorization (PDF, 285 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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FilmArray NGDS BT-E Assay |
October 25, 2014 (initial issuance) March 2, 2015 (reissuance)
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Authorization (PDF, 326 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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FilmArray Biothreat-E test |
October 25, 2014 November 12, 2019 (amended) |
Authorization (PDF, 73 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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RealStar Ebolavirus RT-PCR Kit 1.0 |
November 10, 2014 (initial issuance) November 26, 2014 (reissuance)
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Authorization (PDF, 263 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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LightMix Ebola Zaire rRT-PCR Test |
December 23, 2014 |
Authorization (PDF, 2.2 MB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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Xpert Ebola Assay |
March 23, 2015 |
Authorization (PDF, 240 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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Idylla Ebola Virus Triage Test (Biocartis NV) |
May 26, 2016 |
Authorization (PDF, 321 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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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) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
| 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) |
|---|---|---|---|---|---|---|
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CDC Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR) |
May 12, 2015 |
Authorization (PDF, 229 KB) |
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Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 (February 6, 2015) |
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) |
|---|---|---|---|---|---|---|
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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) |
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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) |
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
| 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) |
|---|---|---|---|---|---|---|
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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
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Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) |
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.) |
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Quidel Lyra Influenza A Subtype H7N9 Assay |
February 14, 2014 |
Authorization (PDF, 57 KB) |
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Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) |
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.) |
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A/H7N9 Influenza Rapid Test |
April 25, 2014 |
Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) |
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.) |
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
| 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) |
|---|---|---|---|---|---|---|
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CDC Novel Coronavirus 2012 Real-time RT-PCR Assay |
June 5, 2013 (initial issuance) June 10, 2014 (reissuance)
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Authorization (PDF, 2.2 MB) |
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RealStar MERS-CoV RT-PCR Kit U.S. |
July 17, 2015 February 12, 2016 (reissuance)
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Authorization (PDF, 238 KB) |
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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) |
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Determination and Declaration Regarding Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning (April 11, 2017) |
Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures (April 11, 2017) |
Zika virus response updates from FDA
Zika virus diagnostic development information
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
Draft EUA review templates for Zika are available by email request to: [email protected]
Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at [email protected], 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) |
|---|---|---|---|---|---|---|
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CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay |
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) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) |
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) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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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) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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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) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Aptima Zika Virus assay (Hologic, Inc.) |
June 17, 2016 (initial issuance) September 7, 2016 (amended) April 12, 2017 (amended) March 8, 2018 (amended)
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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)
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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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) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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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) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Sentosa SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.) |
September 23, 2016 |
Authorization (PDF, 355 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Zika Virus Detection by RT-PCR Test (ARUP Laboratories) |
September 28, 2016 |
Authorization (PDF, 98 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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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) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics) |
December 9, 2016 |
Authorization (PDF, 312 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Gene-RADAR Zika Virus Test (Nanobiosym Diagnostics, Inc.) |
March 20, 2017 |
Authorization (PDF, 313 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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TaqPath Zika Virus Kit (Thermo Fisher Scientific) |
August 2, 2017 |
Authorization (PDF, 292 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)
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CII-ArboViroPlex rRT-PCR Assay (Columbia University) |
August 11, 2017 |
Authorization (PDF, 377 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Related Links
- Coronavirus Disease 2019 (COVID-19)
- Summary of Process for EUA Issuance
- Current Emergency Use Authorizations for Medical Devices
- 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