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
Recommended Actions
- Engage with FDA early through pre-EUA activities before submitting formal EUA request
- 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
- Establish systems for:
- Adverse event monitoring and reporting
- Record keeping and documentation
- Product distribution tracking
- Quality control and compliance
- Develop plans for:
- Healthcare provider and recipient communication
- Product distribution and administration
- Post-authorization safety monitoring
- Compliance with any conditions of authorization
- Maintain active development program toward full approval if applicable
- Monitor for any changes requiring amendment or reissuance of EUA
- 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
- Record keeping requirements for manufacturers and distributors
- Distribution and administration conditions may be imposed
- CGMP compliance expected but waivers possible
- Advertising/promotional materials may be restricted
- Prescription requirements may be waived if appropriate
Relevant Guidances
- Safety and Performance Requirements for Cabinet X-ray Security Screening and Industrial Quality Control Systems
- Laser Products - Performance Standards and Safety Requirements
- Design Controls for Medical Device Manufacturers
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Quality System Information Requirements for Premarket Submissions
Related references and norms
- 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
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