The act and the HDE regulations do not require informed consent. Because an HDE provides for marketing approval, use of the HUD does not constitute research or an investigation which would normally require consent from the study subjects. However, there is nothing in the law or regulations that prohibits a state or institution from requiring prospective informed consent, when feasible. In fact, most HDE holders have developed patient labeling that incorporates information that may be used to assist a patient in making an informed decision about the use of the device. For example, the patient labeling may contain a discussion of the potential risks and benefits of the HUD, as well as any procedures associated with the use of the device. The HUD labeling also states that the device is a humanitarian use device for which effectiveness for the labeled indication has not been demonstrated. See 21 CFR 814.104(b)(4)(ii).
Unless it is an emergency, before an HUD is used off-label, the agency recommends that the HDE holder obtain FDA approval of the use following the compassionate use policy for unapproved devices. (See Chapter III Expanded Access to Unapproved Devices of the “IDE Policies and Procedures Guidance.”2 ) If FDA approves the compassionate use request, the physician should ensure that the patient protection measures are addressed before the device is used and should devise an appropriate schedule for monitoring the patient. If the situation is life threatening and there is not time to get FDA approval for the off-label use, FDA recommends that the emergency use procedures outlined in the above referenced guidance be followed.
Sometimes a physician or HDE holder may develop a research protocol designed to collect safety and effectiveness data to support a PMA for the device. In that case, an IDE is not needed if the research is within the approved labeling; however, IRB approval for the investigational study must be obtained before the research may begin. Informed consent must also be obtained from the subjects participating in the study. If the research is for a new use, the IDE regulation must be followed. 21 CFR Parts 812, 50, and 56.