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.
Recommended Actions
- Determine the intended distribution channel (OTC vs. prescription) based on device capabilities
- Verify oxygen flow rate meets minimum requirements for intended distribution channel
- Ensure total oxygen delivery capacity meets minimum 90-liter requirement
- Review and adjust labeling to comply with OTC or prescription requirements
- For OTC devices, remove any references to specific medical conditions
- Conduct performance testing to validate flow rate and delivery capacity specifications
- Prepare documentation demonstrating substantial equivalence based on oxygen delivery capacity
- 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
- Devices unable to provide minimum total oxygen delivery capacity of 90 liters will be considered not substantially equivalent to devices in commercial distribution
Relevant Guidances
- Spinal Plating Systems and Vertebral Body Replacement Devices - Content and Testing Requirements for 510k Submissions
- General vs. Specific Indications for Use in Medical Device Substantial Equivalence Determinations
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
Related references and norms
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.