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Task list for off-label use of Humanitarian Device Exemption (HDE)–Approved Devices (2)
Emergent HDE Off-Label Use* Compassionate HDE Off-Label Use† Obtain IRB chairperson's concurrence. If unable to obtain, must report within 5 days. Provide HDE holder (company) with the following: A description of the patient's condition. Obtain informed consent of patient or legal representative, if possible. The circumstances necessitating the use of the device. Provide documentation of independent assessment by uninvolved physician (not referring physician). A discussion of why alternative therapies of diagnostics are unsatisfactory. Obtain institutional clearance, written notice that the IRB acknowledges the off-label use. A follow-up plan to HDE holder for their submission to the FDA. Obtain authorization from HDE holder (company). FDA approved for compassionate use with help of HDE holder.‡ Obtain submission of a follow-up plan to HDE holder for their submission to the FDA. Note:—IRB indicates Institutional Review Board; FDA, US Food and Drug Administration.
* Emergent HDE use: to save life or protect the physical well-being of a patient.
† Compassionate HDE: not an emergency, but no alternative device for the patient's condition exists.
‡ This task is a requirement, whereas all other tasks listed for both emergent and compassionate use are recommendations.
