131. Compassionate Use of an Investigational or Unapproved Device
There are circumstances in which an investigational device is the only option available for a single patient or small group of patients are faced with a serious, albeit not life-threatening condition for which no alternative therapy exists.
- A physician may use an unapproved device to treat, diagnose, or monitor a patient with a serious disease or condition.
- Patients considered for compassionate use may not be eligible for participation in the IDE device study.
- Before the compassionate use, the physician must confirm the risk of harm from the device use is not greater than the risk of the disease.
- The physician must request authorization for compassionate use from sponsor (who may agree or disagree).
- Prior to the compassionate use, the physician must obtain clearance from his/her institution (for affiliate sites), FDA approval, and concurrence from the Biomedical IRB Chair.
- Prior to the compassionate use, the treating physician must obtain independent assessment from uninvolved physician.
- The physician must obtain informed consent from the patient.
- During the compassionate use, the physician must routinely monitor the patient to address the patient's specific needs and detect possible problems.
- The physician must report any problems associated with the device to the IRB and sponsor.
- Following the compassionate use, the physician must provide the sponsor and the IRB with a summary of the use.
IRB Responsibilities for Compassionate Use
- Prior to compassionate use, the IRB must
· document the Chair's concurrence,
· verify FDA concurrence, and
· review and confirm adequacy of the consent document.
- During and after compassionate use, the IRB must receive and assess reports of problems
- After compassionate use, the IRB must receive and the summary report of the device use.