Unanticipated adverse device effect

UADEs have to be reported promptly by investigators to the sponsor and IRB, and by the sponsor to FDA, so the investigational plan needs to describe anticipated effects clearly. The comparable term in EU clinical investigations is the unanticipated serious adverse device effect.

Unanticipated adverse device effect means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

21 CFR, 812.3