While we wait:
Compassionate Use (or Individual Patient/Small Group Access)
What is Compassionate Use?
The FDA recognizes that there are circumstances in which an investigational device is the only option available for a patient faced with a serious or life-threatening disease or condition.
The compassionate use provision provides a path to accessing investigational devices that have not received FDA approval or clearance for patients for whom the treating physician believes the device may provide a benefit in diagnosing, monitoring, or treating their disease or condition. Compassionate use can be for devices that are being studied in a clinical trial under an IDE for patients who do not meet the requirements for inclusion in the clinical investigation but for whom the treating physician believes the device may provide a benefit in treating or diagnosing their disease or condition. It can also be used for devices that are not being studied in a clinical investigation (such as an IDE for the device does not exist). This provision is typically approved for individual patients but may be approved to treat a small group, if the small group request is under an IDE.
Criteria for Compassionate Use
The patient has a life-threatening or serious disease or condition;
There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; and
Potential patient benefit justifies the potential risks of the investigational device.
Is FDA approval required prior to Compassionate Use?
Yes. Prior FDA approval is needed before compassionate use occurs.
How do I request approval for Compassionate Use of a device?
If a licensed physician would like to obtain an investigational device for an individual patient, the medical device company must first agree to provide the investigational device for compassionate use. The FDA cannot require a company to provide an investigational device for compassionate use to proceed. If the device manufacturer agrees to provide the device under compassionate use, there are two different processes to follow to obtain FDA approval, depending on whether or not there is an IDE for a clinical trial for that device.
