All terms
Unanticipated Adverse Device Effect
Any serious adverse effect on health or safety in an IDE study not previously identified in the investigational plan, triggers strict reporting timelines.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026
Definition
An Unanticipated Adverse Device Effect (UADE) is, per 21 CFR 812.3(s), any serious adverse effect on health or safety, any life-threatening problem, or death caused by, or associated with, an investigational device, if that effect was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with the device that relates to the rights, safety, or welfare of subjects. UADEs trigger specific reporting obligations: investigators report to the sponsor and IRB within 10 working days; sponsors report to FDA and all reviewing IRBs as soon as possible but no later than 10 working days after first learning of the effect. What the regulation says
21 CFR 812.3(s) defines UADE; 21 CFR 812.46 governs investigator reporting; 21 CFR 812.150(b)(1) governs sponsor reporting. FDA Form 3500A is not used for UADEs (that's for MDR post-market reports), UADE reports are submitted to CDRH per the IDE supplement framework.What this means in practice
UADE determinations are a defining sponsor responsibility in any IDE-conducted clinical investigation. Misclassification, calling a UADE a routine adverse event, or vice versa, has cascading consequences: IRB suspension authority, FDA enforcement, study integrity. Sponsors maintain a UADE classification process with medical monitor oversight and clear criteria distinguishing UADEs from anticipated adverse events listed in the Investigator Brochure. Common pitfalls
- •Treating any serious adverse event as a UADE, UADEs require the 'unanticipated' criterion plus device association.
- •Missing the 10-working-day clocks, investigator-to-sponsor and sponsor-to-FDA/IRBs both have hard timelines.
- •Failing to update the Investigator Brochure after a UADE is determined, subsequent occurrences of the same effect may no longer qualify as unanticipated.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
eCFR·2ICH·1
- 121 CFR 812.3(s) - UADE DefinitionVerifiedeCFRecfr.gov
- 221 CFR 812.150 - ReportsVerifiedeCFRecfr.gov
- 3ICH GuidelinesVerifiedICHich.org
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