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Emergency Use Authorization
EMERGENCY USE OF CERTAIN MEDICAL PRODUCTS

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) clarifies and enhances FDA’s authority to foster the development and availability of medical products for use in domestic emergencies involving infectious disease threats.

Medical products, also referred to as “medical countermeasures” or “MCMs,” include

  • drugs (antivirals and antidotes)
  • biological products (vaccines, blood products, and biological therapeutics)
  • devices (in vitro diagnostics and personal protective equipment – PPE).

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Emergency Use Authorization of Medical Products

PAHPRA authorizes the emergency use of an unapproved medical product or an unapproved use of an approved medical product to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a chemical, biological, radiological, and nuclear (CBRN) agent, when there are no adequate, approved, and available alternatives, after the United States Secretary of Health and Human Services (HHS) Secretary has made a declaration of emergency or threat justifying emergency use.

On the basis of this determination, the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and or diagnosis of COVID-19, personal respiratory protective devices, and other medical devices, including alternative products used as medical devices.

Emergency Use Authorizations (EUAs) for diagnostic, non-diagnostic, and therapeutic medical devices related to COVID-19 are currently:

  • Blood Purification Devices EUAs
  • Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
  • In Vitro Diagnostics EUAs
    • 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 Clinical Laboratory Improvement Amendments (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-2
    • 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-National Institute for Occupational Safety and Health (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

On June 15, 2020, FDA has determined that hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use.

U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for investigational convalescent plasma to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19, on August 23, 2020.

On August 28, 2020, FDA expanded the authorized use of Veklury ( (remdesivir) by no longer limiting its use to the treatment of patients with severe disease. Remdesivir is an investigational drug and is not currently approved for any indication.

Requests for issuance of EUAs

FDA recommends that a request for an EUA include a well-organized summary of the available scientific evidence regarding the product’s safety and effectiveness, risks (including an adverse event profile) and benefits, and any available, approved alternatives to the product.

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