An Unanticipated Adverse Device Effect (UADE) is a serious adverse effect or safety problem associated with a medical device that was not previously identified in the investigational plan or risk information.
UADEs require prompt reporting to sponsors, IRBs, and regulators, and they may trigger immediate risk mitigation actions. Determining UADE status involves assessing seriousness, relatedness to the device, and whether the effect was unexpected. UADE reporting supports device safety surveillance and informs potential protocol updates or device modifications. Strong UADE processes protect participants and support compliance under device investigation regulations.