--- title: "HDE, Humanitarian Device Exemption | MedTech Terms" description: "FDA marketing pathway for devices treating rare conditions affecting fewer than 8,000 U.S. patients per year. Plain-English Regulatory definition for MedTech te" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/hde#term", "name": "Humanitarian Device Exemption", "alternateName": "HDE", "description": "An HDE is an application similar to a PMA but exempt from the effectiveness requirements. 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This criterion is crucial for determining eligibility for the HDE pathway." } }, { "@type": "Question", "name": "Are there special considerations for pediatric HDE devices?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, for devices intended for pediatric patients, the profit limitations typically associated with HDEs may not apply. This encourages the development of devices for rare diseases in children." } }, { "@type": "Question", "name": "What is the role of an Institutional Review Board (IRB) in the use of HUDs?", "acceptedAnswer": { "@type": "Answer", "text": "The use of a Humanitarian Use Device (HUD) by an institution typically requires approval from an Institutional Review Board (IRB), ensuring ethical considerations and patient protection are addressed. This oversight is critical for patient safety." } }, { "@type": "Question", "name": "Can an HDE device be marketed without an approved HDE application?", "acceptedAnswer": { "@type": "Answer", "text": "No, an HDE device cannot be marketed until the HDE application has been approved by the FDA. Marketing prior to approval would constitute a violation of regulatory requirements." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Humanitarian Device Exemption [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)HDE # Humanitarian Device Exemption FDA marketing pathway for devices treating rare conditions affecting fewer than 8,000 U.S. patients per year. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition An HDE is an application similar to a [PMA](/terms/pma) but exempt from the effectiveness requirements. It allows marketing of a Humanitarian Use Device (HUD) intended to benefit patients with rare diseases or conditions. What the regulation says The FDA’s Humanitarian Device Exemption (HDE) program, outlined in 21 CFR Part 814 Subpart H, facilitates the development and availability of devices for rare diseases or conditions. Unlike a [Premarket Approval](/terms/pma) (PMA), an HDE application does not require proof of effectiveness, only probable benefit outweighs the risk of injury or illness. The FDA also provides guidance on humanitarian use devices (HUDs), the devices approved under an HDE. ## What this means in practice HDE devices must demonstrate probable benefit outweighs risk of injury or illness. Use is generally restricted, often requiring [IRB](/terms/irb) oversight, and there are profit limitations except in pediatric cases. ## Examples - A company develops an implantable device to treat a rare genetic heart condition affecting a small patient population, and it seeks HDE approval. - A physician wants to use an approved HUD for a patient, requiring their hospital's Institutional Review Board (IRB) to approve the use. - A manufacturer of an HDE device for a pediatric rare neurological disorder submits an annual report to the FDA, detailing the device's sales and usage. Common pitfalls - • A common misconception is that HDE devices do not require clinical data; however, clinical data is necessary to demonstrate probable benefit and assess risks. - • Failing to understand the profit limitations for HDE devices, which generally cap annual sales, can lead to compliance issues. - • Manufacturers sometimes overlook the ongoing post-approval requirements, including reporting adverse events and changes to the device. - • Confusing the HDE process with other regulatory pathways, such as 510(k) or PMA, can lead to incorrect application strategies. ## Frequently asked questions What defines a rare disease or condition for an HDE? For HDE purposes, a rare disease or condition is one that affects fewer than 4,000 individuals in the United States per year. This criterion is crucial for determining eligibility for the HDE pathway. Are there special considerations for pediatric HDE devices? What is the role of an Institutional Review Board (IRB) in the use of HUDs? Can an HDE device be marketed without an approved HDE application? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ 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) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 European Commission· 1 IMDRF· 1 1. [1 Humanitarian Device Exemption Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption) 2. [2 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 3. [3 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [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 Regulatory Acronym HDE Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=hde) Learn in 60 seconds Card Lesson Quiz FDA marketing pathway for devices treating rare conditions affecting fewer than 8,000 U.S. patients per year. - · HDE devices must demonstrate probable benefit outweighs risk of injury or illness. - · Use is generally restricted, often requiring IRB oversight, and there are profit limitations except in pediatric cases. - · It allows marketing of a Humanitarian Use Device (HUD) intended to benefit patients with rare diseases or conditions. Remember this Watch out: A common misconception is that HDE devices do not require clinical data; however, clinical data is necessary to demonstrate probable benefit and assess risks. Related terms - [Premarket Approval(PMA) ](/terms/pma) - [Investigational Device Exemption(IDE) ](/terms/ide) - [Institutional Review Board(IRB) ](/terms/irb) You may also need Auto-suggested from Regulatory and shared keywords. - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [IVDR Legacy Device ](/terms/ivdr-legacy-device) - [Medhacking ](/terms/medhacking) - [Additional Condition for Nonprescription Use(ACNU) ](/terms/acnu) - [Companion Diagnostic (IVDR)(CDx) ](/terms/ivdr-companion-diagnostic) - [Emergency Use Authorization(EUA) ](/terms/eua) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ 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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