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.
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 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.- •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.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsAny untoward medical occurrence in a subject, whether or not related to the device.
Annual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events.
Amendment to an approved Investigational Device Exemption for protocol or device changes.
Voluntary, informed agreement to participate in research after disclosure of risks and benefits.
More in Clinical & Trials
· Same categoryBoard that reviews and approves human-subjects research at an institution.
FDA authorization to use an investigational device in a clinical study.
Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations.
Adverse event resulting in death, life-threat, hospitalization, persistent disability, or congenital anomaly.
Primary references
3 sources- 1
21 CFR 812.3(s) - UADE DefinitionVerifiedeCFRecfr.gov
- 2
21 CFR 812.150 - ReportsVerifiedeCFRecfr.gov
- 3
ICH GuidelinesVerifiedICHich.org
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