In general, an unapproved medical device may be used only on human subjects when the device is under clinical investigation and when used by investigators participating in a clinical trial. However, there may be circumstances under which a health care provider may wish to use an unapproved device to save the life of a patient or to prevent irreversible morbidity when there exists no other alternative therapy. For investigational devices under an Investigational Device Exemption (IDE), the IDE regulation permits deviations from the investigational plan without prior approval when necessary to protect the life or physical well-being of a subject in an emergency. In such cases the health care provider should do their utmost to secure:
- Informed consent from the patient
- Clearance from the institution
- Approval by the IRB chairperson
- An assessment from another physician not participating in the study
- Authorization from the Ide sponsor if there is an IDE for the device
After emergency use, a detailed report should be made to FDA (if there is an IDE for the device) or CDRH or CBER (if there is not).
What if the situation is not an emergency? Can a patient with a serious illness or condition have access to an investigational device outside a study? Yes, FDA recognizes that there are circumstances in which an investigational device is the only option available for a patient faced with a life-threatening condition. Unlike emergency use of an unapproved device discussed above, prior FDA approval is needed before compassionate use occurs. Section 561(b) of the act and 21 CFR 812.35. In order to obtain agency approval, the sponsor should submit an IDE supplement requesting approval for a protocol deviation under section 812.35(a) in order to treat the patient. The IDE supplement should include:
- Description of the patient’s condition and the circumstances necessitating treatment
- Discussion of why alternative therapies are unsatisfactory and why the probable risk of using the investigational device is no greater than the probable risk from the disease or condition
- An identification of any deviations in the approved clinical protocol that may be needed in order to treat the patient, and
- The patient protection measures listed above
The patient should not be treated until FDA approves the device’s use. The FDA will consider all the information above, along with preliminary evidence of safety and effectiveness. If the request is approved, the patient will be continuously monitored and a follow-up report must be submitted.