--- title: "SAE, Serious Adverse Event | MedTech Terms" description: "Adverse event resulting in death, life-threat, hospitalization, persistent disability, or congenital anomaly. 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Serious Adverse Event [All terms](/terms) Clinical & Trials [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Clinical Evidence](/ecosystems/clinical-evidence)[Post-Market & Safety](/ecosystems/post-market-safety)SAE # Serious Adverse Event Adverse event resulting in death, life-threat, hospitalization, persistent disability, or congenital anomaly. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition An SAE per [ISO 14155](/terms/iso-14155) is any AE that led to death; serious deterioration in health resulting in life-threatening illness or injury, permanent impairment, in-patient hospitalization, or medical/surgical intervention; or fetal distress or congenital anomaly. What the regulation says Regulators such as FDA and notified bodies under EU [MDR](/terms/mdr-reporting), and standards like [ISO 14155](/terms/iso-14155), mandate strict reporting requirements for Serious Adverse Events. These requirements ensure that any significant safety concerns arising during clinical investigations are promptly communicated to safeguard participant well-being and inform regulatory decision-making regarding device safety and efficacy. ## What this means in practice Sponsors must report SAEs and SADEs to regulators and IRBs/ECs within defined timeframes (often 7 or 15 days depending on jurisdiction and seriousness). ## Examples - A participant in a clinical trial for a novel cardiac stent experiences a myocardial infarction leading to emergency hospitalization, which is classified as a Serious Adverse Event. - A subject using an investigational continuous glucose monitor develops severe hypoglycemia requiring intervention, meeting the definition of a Serious Adverse Event due to serious deterioration in health. - During a clinical study, a participant succumbs to an unforeseen illness unrelated to the investigational device, but because it resulted in death, it is still reported as a Serious Adverse Event by the study sponsor. Common pitfalls - • Confusing a Serious Adverse Event with an Adverse Event, which has different reporting criteria. - • Failing to report a Serious Adverse Event within the mandated timeframe, leading to non-compliance. - • Misinterpreting the criteria for "serious deterioration in health" or "life-threatening illness or injury." - • Not having a clear internal procedure for identifying, documenting, and reporting Serious Adverse Events. - • Failing to track all required data elements for a Serious Adverse Event report. ## Frequently asked questions What is the primary difference between an Adverse Event and a Serious Adverse Event? An [Adverse Event](/terms/adverse-event) (AE) is any untoward medical occurrence, while a Serious Adverse Event (SAE) specifically meets criteria indicating a serious outcome like death, life-threatening illness, or permanent impairment, as defined by [ISO 14155](/terms/iso-14155). Who is responsible for reporting Serious Adverse Events? What are typical reporting timeframes for Serious Adverse Events? ## Cross-references ### Part of A larger framework or document this term belongs to. - [ Adverse Event(AE) ](/terms/adverse-event) ## 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)[ Standards ISO 14155 Good clinical practice for clinical investigations of medical devices. ](/terms/iso-14155)[ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. ](/terms/vigilance) ### More in Clinical & Trials · Same category [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Clinical & Trials ALCOA+ Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available). ](/terms/alcoa-plus)[ Clinical & Trials Analytical Sensitivity An IVD's ability to detect small quantities of an analyte. ](/terms/analytical-sensitivity)[ Clinical & Trials Bayesian Trial Design Trial design that uses Bayesian statistics, often incorporating prior data from related studies or registries. ](/terms/bayesian-trial) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Post-Market & Safety](/ecosystems/post-market-safety) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 1 FDA· 1 NIH· 1 1. [1 ISO 14155:2020 Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) 2. [2 FDA - Clinical Trials and Human Subject Protection Verified FDA · fda.gov ](https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection) 3. [3 ClinicalTrials.gov Verified NIH · clinicaltrials.gov ](https://clinicaltrials.gov/) 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 SAE Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=sae) Learn in 60 seconds Card Lesson Quiz Adverse event resulting in death, life-threat, hospitalization, persistent disability, or congenital anomaly. - · Sponsors must report SAEs and SADEs to regulators and IRBs/ECs within defined timeframes (often 7 or 15 days depending on jurisdiction and seriousness). Remember this Watch out: Confusing a Serious Adverse Event with an Adverse Event, which has different reporting criteria. Related terms - [Adverse Event(AE) ](/terms/adverse-event) - [ISO 14155 ](/terms/iso-14155) - [Medical Device Vigilance ](/terms/vigilance) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Unanticipated Adverse Device Effect(UADE) ](/terms/uade) - [Class III Device ](/terms/class-iii) - [FDA Recall Classifications I, II, III ](/terms/recall-classifications) - [Software Safety Classification ](/terms/software-safety-class) - [Composite Endpoint ](/terms/composite-endpoint) - [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting) [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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