There are three different mechanisms for expanded access of an unapproved device:
- Emergency Use for an individual patient
- If there is not time to obtain IRB approval for the treatment use of an investigational product (drug/biologic, or device), this constitutes an emergency use, and treating teams should follow this guidance: Emergency, Expanded Access for an Investigational Medical Product (One Patient).
- Compassionate Use (or Individual Patient/Small Group Access)
- Used 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. 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.
- Treatment Investigational Device Exemption (IDE)
- An approved IDE specifies the maximum number of clinical sites and the maximum number of human subjects that may be enrolled in the study. During the course of the clinical trial, if the data suggest that the device is effective, then the trial may be expanded under a new IDE to include additional patients with life-threatening or serious diseases. This is called a treatment IDE.