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.
Initial review: Initial IRB approval should be performed at a convened IRB meeting. The IRB does not need to review and approve individual uses of an HUD, but rather the IRB may approve use of the device as it sees fit.
An HUD is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year
A Humanitarian Device Exemption (HDE) application is similar to a PMA, but because a HUD is exempt from the effectiveness requirements of a PMA, an HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose.