{"id":17056,"date":"2026-07-20T11:05:09","date_gmt":"2026-07-20T15:05:09","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=17056"},"modified":"2026-09-29T13:40:34","modified_gmt":"2026-09-29T17:40:34","slug":"adverse-device-effects","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/resources\/adverse-device-effects\/","title":{"rendered":"Adverse Device Effects"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"","protected":false},"author":82,"featured_media":0,"parent":236,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-17056","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Adverse Device Effects","subtitle":"","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_external_video_url":"","hero_external_video_title":"","hero_external_video_poster":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2>Description<\/h2>","content":"The investigational device exemption (IDE) regulations define an\u00a0<strong>unanticipated adverse device effect<\/strong>\u00a0(UADE) as \u201cany 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\u00a0<em>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\u201d (21 CFR 812.3(s)).<\/em>\r\n\r\nYou 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)).\r\n\r\nPlease review <a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/unanticipated-problems\/\">Unanticipated Problems<\/a> and <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/irb-submissions\/reports-of-new-information\/\">Report of New Information<\/a> for more details.","background_color":"#ffffff","width":"width-medium"}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - 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