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Emergency Use Oxygen Generators and Oxygen Equipment: Flow Rate and Distribution Requirements

This guidance outlines the requirements for oxygen generators and oxygen equipment intended for emergency use, specifically addressing the criteria for over-the-counter (OTC) distribution versus prescription devices based on flow rates and total oxygen delivery capacity.

  1. Determine the intended distribution channel (OTC vs. prescription) based on device capabilities
  2. Verify oxygen flow rate meets minimum requirements for intended distribution channel
  3. Ensure total oxygen delivery capacity meets minimum 90-liter requirement
  4. Review and adjust labeling to comply with OTC or prescription requirements
  5. For OTC devices, remove any references to specific medical conditions
  6. Conduct performance testing to validate flow rate and delivery capacity specifications
  7. Prepare documentation demonstrating substantial equivalence based on oxygen delivery capacity
  8. Implement appropriate quality controls to ensure consistent performance meeting the specified requirements

Key Considerations

Non-clinical testing

  • Minimum flow rate of 6 liters of oxygen per minute for OTC devices
  • Flow rate must be maintained for a minimum of 15 minutes
  • Minimum total oxygen delivery capacity of 90 liters for both OTC and prescription devices

Labelling

  • OTC devices cannot include references to heart attacks, strokes, shock, or any medical conditions that only licensed practitioners diagnose or treat
  • Prescription devices must bear the prescription legend
  • Prescription devices cannot be labeled for emergency use

Other considerations

No specific norms or standards are referenced in this guidance.


Original guidance

  • Emergency Use Oxygen Generators and Oxygen Equipment: Flow Rate and Distribution Requirements
  • HTML
  • Issue date: 1977-01-01
  • Last changed date: 2021-04-27
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 9e8aeaae9b51c622c15be45f60ca9ff4
This post is licensed under CC BY 4.0 by the author.