--- title: "UADE, Unanticipated Adverse Device Effect | MedTech Terms" description: "Any serious adverse effect on health or safety in an IDE study not previously identified in the investigational plan, triggers strict reporting timelines." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/uade#term", "name": "Unanticipated Adverse Device Effect", "alternateName": "UADE", "description": "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. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Unanticipated Adverse Device Effect [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)[Post-Market & Safety](/ecosystems/post-market-safety)[Startup Lifecycle](/ecosystems/startup-lifecycle)UADE # 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 Cyber](/authors/christian-espinosa) Last 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](/terms/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](/terms/mdr-reporting) post-market reports), UADE reports are submitted to CDRH per the [IDE supplement](/terms/ide-supplement) framework. ## What this means in practice UADE determinations are a defining sponsor responsibility in any [IDE](/terms/ide)\-conducted clinical investigation. Misclassification, calling a UADE a routine [adverse event](/terms/adverse-event), or vice versa, has cascading consequences: [IRB](/terms/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](/terms/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. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event)[ Clinical & Trials IDE Annual Progress Report Annual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events. ](/terms/ide-annual-report)[ Clinical & Trials IDE Supplement Amendment to an approved Investigational Device Exemption for protocol or device changes. ](/terms/ide-supplement)[ Clinical & Trials Informed Consent Voluntary, informed agreement to participate in research after disclosure of risks and benefits. ](/terms/informed-consent) ### More in Clinical & Trials · Same category [ Clinical & Trials Institutional Review Board(IRB) Board that reviews and approves human-subjects research at an institution. ](/terms/irb)[ Clinical & Trials Investigational Device Exemption(IDE) FDA authorization to use an investigational device in a clinical study. ](/terms/ide)[ Clinical & Trials Investigator Brochure(IB) Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations. ](/terms/investigator-brochure)[ Clinical & Trials Serious Adverse Event(SAE) Adverse event resulting in death, life-threat, hospitalization, persistent disability, or congenital anomaly. ](/terms/sae) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 2 ICH· 1 1. [1 21 CFR 812.3(s) - UADE Definition Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812/subpart-A/section-812.3) 2. [2 21 CFR 812.150 - Reports Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812/subpart-G/section-812.150) 3. [3 ICH Guidelines Verified ICH · ich.org ](https://www.ich.org/page/ich-guidelines) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Acronym UADE Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=uade) Learn in 60 seconds Card Lesson Quiz Any serious adverse effect on health or safety in an IDE study not previously identified in the investigational plan, triggers strict reporting timelines. - · 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. Remember this Watch out: Treating any serious adverse event as a UADE, UADEs require the 'unanticipated' criterion plus device association. Related terms - [Investigational Device Exemption(IDE) ](/terms/ide) - [IDE Supplement ](/terms/ide-supplement) - [IDE Annual Progress Report ](/terms/ide-annual-report) - [Investigator Brochure(IB) ](/terms/investigator-brochure) - [Adverse Event(AE) ](/terms/adverse-event) - [Serious Adverse Event(SAE) ](/terms/sae) - [Institutional Review Board(IRB) ](/terms/irb) - [Informed Consent ](/terms/informed-consent) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Removal vs Correction (21 CFR 806) ](/terms/removal-vs-correction) - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) - [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) - [Annual Report (PMA) ](/terms/annual-report-pma) - [Medical Device Vigilance ](/terms/vigilance) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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