FDA Classifies Humidified Oxygen Delivery Devices, Assigns Special Controls

The FDA has classified high flow humidified oxygen delivery devices as Class II with special controls to provide a reasonable assurance of safety and efficacy.

The final order identifies risks to health associated with the devices and their mitigation measures — such as adverse tissue reactions, device interference, electrical shock injuries and software failure that delays therapy — and notes that a device must comply with the order’s special controls to remain in Class II.

In order to demonstrate the device is reasonably safe and effective, numerous device functions and components need to be tested by the sponsor, including its alarm system and humidity output.