The HDE regulations do not require informed consent. However, states and institutions are not prohibited from setting their own requirements for prospective informed consent. Many HDE holders choose to apply patient labeling that incorporates information to help patients make informed decisions about the use of the device, such as information about risks or procedures associated with the device. Per 21 CFR 814, Humanitarian Use Device (HUD) labeling also states that the device is an HUD for which effectiveness for the labeled indication has not been demonstrated.
We recommend obtaining FDA approval before using any HUD off-label, except in life-threatening emergencies. The compassionate use policy for unapproved devices is one way of seeking this approval.
A Humanitarian Device Exemption (HDE) holder or physician make seek to collect safety and effectiveness data to support a future PMA for their HUD. In this case, an Investigational Device Exemption (IDE) is not needed so long as the research is within the HUD’s approved labeling. IRB approval must be secured before beginning the study, and informed consent must be obtained from all subjects. If the research is for a new, unapproved use, then IDE regulation must be followed.