Coronavirus Disease 2019 (COVID-19)

Emergency Use Authorizations for Medical Devices

About Emergency Use Authorizations (EUAs)

Pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA has authority to 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.

*: CBRN = chemical, biological, radiological, nuclear

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 medical countermeasures (MCMs) needed during public health emergencies.

Section 564 of the FD&C Act was amended by the following authorities:

  • the Project Bioshield Act of 2004
  • the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
  • the 21st Century Cures Act of 2016
  • Public Law 115-92 of 2017
    • Public Law 115-92, enacted December 12, 2017, amended section 564 of the FD&C Act to allow for emergency uses of medical products for threats in addition to biological, chemical, radiological, or nuclear agent(s), to include other agents that may cause or are associated with, an imminently life-threatening and specific risk to the U.S. military forces.

On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (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). The virus is now named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the disease COVID-19.

The Emergency Use Authorizations (EUAs) for diagnostic and therapeutic medical devices related to COVID-19

EUA Overviews

Detailed Information for all COVID-19 EUAs, including authorizations and fact sheets

  • Blood Purification Devices
  • Continuous Renal Replacement Therapy and Hemodialysis Devices
  • In Vitro Diagnostics
    • Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2
    • Umbrella EUA for Molecular Diagnostic Tests for SARS-CoV-2
    • Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
    • Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
    • Individual EUAs for Serology Tests for SARS-CoV-2
    • Umbrella EUA for Independently Validated Serology Tests for SARS-CoV-
    • Individual EUAs for IVDs for Management of COVID-19 Patients
  • Decontamination Systems for Personal Protective Equipment EUAs
  • Infusion Pump EUAs
  • Personal Protective Equipment EUAs
    • N95 and Other Respirators EUAs (including EUAs for NISOH-approved N95s and imported respirators)
    • Umbrella EUA for Non-NIOSH-Approved Disposable Filtering
    • Facepiece Respirators (FFRs)Manufactured in China
    • Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)
    • Face Shields and Other Barrier EUAs
  • Remote or Wearable Patient Monitoring Devices EUAs
  • Respiratory Assist Devices EUAs
  • Ventilators and Ventilator Accessories EUAs
  • Other Medical Device EUAs

View access links at FDA EUA here

Last Updated: 2020-06-18

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