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.
What You Need to Know? 👇
What are the minimum flow rate requirements for OTC oxygen generators for emergency use?
OTC oxygen generators must deliver a minimum flow rate of 6 liters of oxygen per minute, maintained for at least 15 minutes, establishing a minimum total oxygen delivery capacity of 90 liters.
Can emergency oxygen equipment reference specific medical conditions in their labeling?
No, OTC emergency oxygen equipment labeling cannot reference heart attacks, strokes, shock, or any medical conditions that only licensed practitioners can diagnose or treat.
When is an oxygen generator classified as a prescription device?
Oxygen generators that don’t meet the 6 L/min for 15 minutes criteria are prescription devices, requiring the prescription legend, provided they still deliver 90 liters total capacity.
What happens if an oxygen device cannot deliver 90 liters total capacity?
Devices unable to provide minimum 90 liters total oxygen delivery capacity, regardless of flow rate, are considered not substantially equivalent to commercially distributed devices.
What is the difference between emergency use and therapeutic oxygen devices?
Emergency use devices are OTC with specific flow requirements and labeling restrictions. Therapeutic devices are prescription-only, have therapeutic value but cannot be labeled for emergency use.
How does FDA classify oxygen equipment that meets therapeutic but not emergency criteria?
These devices are classified as prescription devices with therapeutic value. They must bear prescription legend and cannot be labeled for emergency use, despite meeting the 90-liter capacity requirement.
What You Need to Do 👇
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 ID: 9e8aeaae9b51c622c15be45f60ca9ff4