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About Emergency Use Authorizations (EUAs)

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow 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 there are no adequate, approved, and available alternatives.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.

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. A separate determination and declaration are needed under section 564 of the Federal Food, Drug and Cosmetic Act to enable FDA to issue EUAs, provided other statutory criteria are met.

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

Coronavirus Disease 2019 (COVID-19) EUA Information

1 Settings for use include the following:

H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.

W - Patient care settings operating under a CLIA Certificate of Waiver.

2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.

3 Abbreviations: CLIA = chemiluminescence immunoassay; ELISA = enzyme-linked immunosorbent assay; ECLIA = electrochemiluminescence immunoassay; FMIA = fluorescent microsphere Immunoassay; CMIA = chemiluminescent microparticle immunoassay; RT-PCR = reverse transcriptase polymerase chain reaction; RT = reverse transcriptase; LAMP = loop-mediated isothermal amplification; MALDI-TOF = Matrix Assisted Laser Desorption/Ionization – Time of Flight; TMA = Transcription Mediated Amplification; qSTAR = Selective Temperature Amplification Reaction; CRISPR = clustered regularly interspaced short palindromic repeats

4 U = On March 31, 2020, FDA issued an umbrella EUA for High Complexity Molecular-Based Laboratory Developed Tests. The EUA letter of authorization is here. Tests that are authorized under this EUA are designated by "U" in the table.

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

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 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.

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Other Current EUAs

The tables below provide information on current EUAs:

Information about EUAs that are no longer in effect is available on our EUA archive page.

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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

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