Non-emergent Medical Device Compassionate Use
IMPORTANT: A single patient compassionate use request may take up to 30-days for FDA to perform a safety review. If the intervention must occur within days to weeks, follow the procedures for an Emergency Use request. Emergency Use requests are not required to be submitted to the IIS team. Work directly with the device manufacturer, FDA, and IRB. The IIS team is available for guidance on an Emergency Use request.
What is compassionate use /expanded access?
Compassionate use (aka expanded access), is a potential pathway for patients with a serious or life-threatening disease or condition to access an investigational medical device that has not been approved or cleared by the FDA for treatment outside of clinical trials and no comparable or satisfactory alternative therapy options exist.
Who is eligible for compassionate use?
- Patients with an immediately life-threatening disease or condition defined as a stage of disease in which there is reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment; OR
- Patients with a serious disease or condition associated with morbidity that has substantial impact on day-to-day functioning.
Who can make a compassionate use request?
The patient’s treating physician typically makes the request. However, if a manufacturer or another physician has an Investigational Device Exemption (IDE) Application approved by the FDA, it is possible for the IDE sponsor to submit an IDE supplement requesting approval for a compassionate use under section 21 CFR Part 812.35(a) to treat the patient.
Unless FDA notifies the sponsor that treatment may begin earlier, there is a 30-day waiting period before treatment may begin.
Is it possible to treat more than one patient under compassionate use?
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.
Compassionate Use Resources, Forms, and Templates
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FDA Information for Physicians Requesting Compassionate Use
Single Patient Non-Emergent Compassionate Use Request
Template for Single Patient Compassionate Use