--- title: "HHE, Health Hazard Evaluation | MedTech Terms" description: "Structured assessment of patient/user risk used to support recall classification and field-action decisions. Plain-English Post-Market definition for MedTech te" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/health-hazard-eval#term", "name": "Health Hazard Evaluation", "alternateName": "HHE", "description": "An HHE evaluates the disease/condition affected, severity of consequence, probability of occurrence, exposed population, and mitigations. The output supports recall classification (I/II/III) and the urgency of customer notification.", "url": "https://medtechterms.com/terms/health-hazard-eval", "termCode": "health-hazard-eval", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/health-hazard-eval#article", "headline": "HHE, Health Hazard Evaluation", "description": "Structured assessment of patient/user risk used to support recall classification and field-action decisions.", "url": "https://medtechterms.com/terms/health-hazard-eval", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/health-hazard-eval" }, "about": { "@id": "https://medtechterms.com/terms/health-hazard-eval#term" }, "articleSection": "Post-Market", "inLanguage": "en", "keywords": "Health Hazard Evaluation, HHE, Post-Market, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "FDA Recall Procedures", "url": "https://www.fda.gov/safety/industry-guidance-recalls", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "EUDAMED Public Site", "url": "https://ec.europa.eu/tools/eudamed/", "publisher": { "@type": "Organization", "name": "European Commission" } }, { "@type": "CreativeWork", "name": "MDCG Vigilance Guidance", "url": "https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en", "publisher": { "@type": "Organization", "name": "MDCG" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/recall-classifications#term", "name": "FDA Recall Classifications I, II, III", "url": "https://medtechterms.com/terms/recall-classifications" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/fsca#term", "name": "Field Safety Corrective Action", "alternateName": "FSCA", "url": "https://medtechterms.com/terms/fsca" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Post-Market", "item": "https://medtechterms.com/terms?cat=Post-Market" }, { "@type": "ListItem", "position": 4, "name": "Health Hazard Evaluation", "item": "https://medtechterms.com/terms/health-hazard-eval" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/health-hazard-eval#faq", "mainEntity": [ { "@type": "Question", "name": "Who typically conducts a Health Hazard Evaluation?", "acceptedAnswer": { "@type": "Answer", "text": "A cross-functional team, often including medical professionals, toxicologists, engineers, and regulatory specialists, typically conducts an HHE to ensure a comprehensive assessment." } }, { "@type": "Question", "name": "What is the primary purpose of an HHE in the context of recalls?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose is to determine the appropriate recall classification (Class I, II, or III) and to establish the urgency and scope of the recall actions required to protect public health." } }, { "@type": "Question", "name": "How does an HHE relate to risk management activities?", "acceptedAnswer": { "@type": "Answer", "text": "An HHE is a specific application of risk management principles, focusing on assessing health risks associated with a non-conforming product in the post-market phase, often triggered by a complaint or deviation." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Health Hazard Evaluation [All terms](/terms) Post-Market [Quality System](/ecosystems/quality-system)[Post-Market & Safety](/ecosystems/post-market-safety)[Startup Lifecycle](/ecosystems/startup-lifecycle)HHE # Health Hazard Evaluation Structured assessment of patient/user risk used to support recall classification and field-action decisions. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition An HHE evaluates the disease/condition affected, severity of consequence, probability of occurrence, exposed population, and mitigations. The output supports recall classification (I/II/III) and the urgency of customer notification. What the regulation says The FDA, under 21 CFR Part 7, Subpart C, mandates a health hazard evaluation to assess the risk posed by a violative product and classify recalls accordingly. This assessment informs the recall strategy, including the depth of the recall and public warning. Similarly, [ISO 14971](/terms/iso-14971):2019, though broader in scope, requires organizations to evaluate risks associated with medical devices, which aligns with the principles of an HHE. ## What this means in practice FDA recall coordinators frequently require an updated HHE during recall negotiation; pre-built templates accelerate response. ## Examples - A manufacturer performs an HHE after discovering a software bug that could cause inaccurate therapy delivery, determining a Class I recall is necessary due to potential serious injury or death. - Following a customer complaint of device malfunction, an HHE assesses the likelihood of patient harm to classify a recall as Class II, requiring device correction and customer notification. - An HHE is conducted for a labeling error that does not directly impact device function or patient safety, resulting in a Class III recall for minor product correction. Common pitfalls - • Failing to update an HHE when new information or complaints emerge can lead to an incorrect recall classification. - • Underestimating the severity of a health consequence can result in an inadequate recall strategy. - • Not clearly documenting the HHE methodology and conclusions can lead to regulatory scrutiny. - • Confusing a health hazard evaluation with a routine risk assessment can misdirect post-market activities. - • Delaying the completion of an HHE can prolong patient exposure to hazardous products and worsen regulatory outcomes. ## Frequently asked questions Who typically conducts a Health Hazard Evaluation? A cross-functional team, often including medical professionals, toxicologists, engineers, and regulatory specialists, typically conducts an HHE to ensure a comprehensive assessment. What is the primary purpose of an HHE in the context of recalls? How does an HHE relate to risk management activities? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market FDA Recall Classifications I, II, III FDA's risk-based grading of recalls based on potential for harm. ](/terms/recall-classifications)[ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca) ### More in Post-Market · Same category [ Post-Market 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report)[ Post-Market Annual Report (PMA) Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. ](/terms/annual-report-pma)[ Post-Market Customer Notification Letter Communication to users notifying them of a safety issue, corrective action, or important product information. ](/terms/customer-notification)[ Post-Market Electronic Medical Device Reporting(eMDR) FDA's mandatory electronic submission system for Medical Device Reports. ](/terms/emdr) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Quality System](/ecosystems/quality-system) - [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 FDA· 1 European Commission· 1 MDCG· 1 1. [1 FDA Recall Procedures Verified FDA · fda.gov ](https://www.fda.gov/safety/industry-guidance-recalls) 2. [2 EUDAMED Public Site Verified European Commission · ec.europa.eu ](https://ec.europa.eu/tools/eudamed/) 3. [3 MDCG Vigilance Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [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 Post-Market Acronym HHE Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=health-hazard-eval) Learn in 60 seconds Card Lesson Quiz Structured assessment of patient/user risk used to support recall classification and field-action decisions. - · FDA recall coordinators frequently require an updated HHE during recall negotiation; pre-built templates accelerate response. - · The output supports recall classification (I/II/III) and the urgency of customer notification. Remember this Watch out: Failing to update an HHE when new information or complaints emerge can lead to an incorrect recall classification. Related terms - [FDA Recall Classifications I, II, III ](/terms/recall-classifications) - [Field Safety Corrective Action(FSCA) ](/terms/fsca) You may also need Auto-suggested from Post-Market and shared keywords. - [Customer Notification Letter ](/terms/customer-notification) - [Benefit-Risk Determination ](/terms/benefit-risk) - [Medical Device Recall ](/terms/recall) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)