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

  1. Prior to compassionate use, the IRB must

·        document the Chair's concurrence,

·        verify FDA concurrence, and

·        review and confirm adequacy of the consent document.

  1. During and after compassionate use, the IRB must receive and assess reports of problems
  2. After compassionate use, the IRB must receive and the summary report of the device use.

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