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The investigational device exemption (IDE) regulations define an聽unanticipated adverse device effect聽(UADE) as 糖心传媒渁ny 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聽in a 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糖心传媒� (21 CFR 812.3(s)).

You must immediately conduct an evaluation of a UADE and must report the results of the evaluation to the FDA, the IRB, and all participating investigators within 10 calendar days after the sponsor first receives notice of the effect (21 CFR 812.46(b), 812.150(b)(1)).

Please review Unanticipated Problems and Report of New Information for more details.