The FDA provided new clarity on the requirements for gaining access to investigational devices and the application process to gain access.
Patients and physicians have the potential to gain expanded access under one of three alternative mechanisms: emergency use, compassionate use and treatment use.
If necessary criteria are met, an unapproved device may be used in an emergency situation without prior approval by the FDA. Included in the new information is a physician’s list of patient protection procedures that must be obtained to demonstrate benefit, including authorization from the device manufacturer. The sponsor must report emergency use of an IDE to the FDA within five days.
The compassionate use section has been expanded to cover devices that are being studied in a clinical trial under an IDE for patients who do not meet inclusion requirements under the clinical trial protocol. Compassionate use can also be gained for devices that are not being studied in a clinical trial or when an IDE for the device does not exist.
The FDA outlines how to request a compassionate use approval, and clarifies that a manufacturer must agree to provide the investigational device for compassionate use. If the device manufacturer agrees, there are two different tracks to proceed, depending on whether or not there is an IDE for a device.
The notice reports a roughly 99% approval rate for compassionate use requests, stating requests with IDE’s were reviewed on average in 18 days and those without IDE’s an average 10 days.
After compassionate use is awarded, companies must submit a follow-up report to the FDA with data on patient outcomes. Any problems need to be reported to the institutional review board immediately.