Post

Emergency Use Authorization of Medical Products: Requirements and Procedures for Unapproved Products and Uses

This guidance explains FDA's recommendations and procedures for authorizing emergency use of medical products under sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). It covers: - Emergency Use Authorizations (EUAs) for unapproved medical products or unapproved uses of approved products - Emergency use authorities for FDA-approved medical countermeasures (MCMs) without an EUA - Pre-positioning of MCMs by government stakeholders before approval or authorization

  1. Engage with FDA early through pre-EUA activities before submitting formal EUA request
  2. Prepare comprehensive submission including:
    • Product description and intended use
    • Available safety and effectiveness data
    • Risk-benefit analysis
    • Quality/manufacturing information
    • Draft Fact Sheets and labeling
    • Proposed monitoring and reporting plans
  3. Establish systems for:
    • Adverse event monitoring and reporting
    • Record keeping and documentation
    • Product distribution tracking
    • Quality control and compliance
  4. Develop plans for:
    • Healthcare provider and recipient communication
    • Product distribution and administration
    • Post-authorization safety monitoring
    • Compliance with any conditions of authorization
  5. Maintain active development program toward full approval if applicable
  6. Monitor for any changes requiring amendment or reissuance of EUA
  7. Prepare for proper product disposition upon EUA termination

Key Considerations

Clinical testing

  • Data from controlled clinical trials if available
  • Clinical experience from other than controlled trials may be considered if circumstances warrant
  • Human safety information from clinical trials and individual patient experience should be provided if available

Non-clinical testing

  • Preclinical testing data required, including in vitro and animal toxicology data
  • Data linking likely exposure to relevant preclinical data
  • Animal data should link results to expected human exposures

Labelling

  • Fact Sheets required for healthcare professionals and recipients
  • Must include information about authorization, benefits/risks, alternatives
  • Should be written in simple language and translated if needed
  • May need additional labeling beyond Fact Sheets for unapproved products

Safety

  • Monitoring and reporting of adverse events required for unapproved products
  • Primary focus on capturing serious adverse events
  • Need mechanisms for collection of follow-up clinical information
  • May require active data collection and follow-up

Other considerations

  • 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
  • 21 CFR Part 50: Protection of Human Subjects
  • 21 CFR Part 820: Quality System Regulation

Original guidance

  • Emergency Use Authorization of Medical Products: Requirements and Procedures for Unapproved Products and Uses
  • HTML / PDF
  • Issue date: 2017-01-13
  • Last changed date: 2024-08-09
  • Status: FINAL
  • Official FDA topics: Medical Devices, Drugs, Emergencies, Premarket, Biologics
  • ReguVirta summary file ID: 135e96248649d22a103344f81f7daa4f
This post is licensed under CC BY 4.0 by the author.