--- title: "SUD, Single-Use Device | MedTech Terms" description: "A device the original manufacturer labels for one use or one patient, distinct from reusable devices and from FDA-regulated reprocessed SUDs." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/single-use-device#term", "name": "Single-Use Device", "alternateName": [ "SUD", "Disposable device", "SUD" ], "description": "A Single-Use Device (SUD) is one whose original-equipment manufacturer (OEM) labeling restricts it to a single use or single patient. The Medical Device User Fee and Modernization Act (MDUFMA) of 2002 created a separate regulatory pathway for third-party reprocessors of SUDs: they must obtain their own 510(k) clearance and comply with the same cleaning, sterilization, and functional-equivalence validation as OEMs. SUDs and reprocessed SUDs are a major sustainability and cost-pressure topic in hospital purchasing.", "url": "https://medtechterms.com/terms/single-use-device", "termCode": "single-use-device", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/single-use-device#article", "headline": "SUD, Single-Use Device", "description": "A device the original manufacturer labels for one use or one patient, distinct from reusable devices and from FDA-regulated reprocessed SUDs.", "url": "https://medtechterms.com/terms/single-use-device", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/single-use-device" }, "about": { "@id": "https://medtechterms.com/terms/single-use-device#term" }, "articleSection": "Market Segments", "inLanguage": "en", "keywords": "Single-Use Device, SUD, Disposable device, SUD, Market Segments, 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": "2026-05-09", "dateModified": "2026-05-09", "citation": [ { "@type": "CreativeWork", "name": "FDA, Reprocessing of Single-Use Devices", "url": "https://www.fda.gov/medical-devices/reprocessing-single-use-medical-devices-information-health-care-facilities/reprocessed-single-use-devices-frequently-asked-questions", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "FDA Guidance, Reprocessing Medical Devices in Health Care Settings (2015)", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-and-labeling", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "MedTech Dive", "url": "https://www.medtechdive.com/", "publisher": { "@type": "Organization", "name": "MedTech Dive" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/endoscopy-devices#term", "name": "Endoscopy Devices", "url": "https://medtechterms.com/terms/endoscopy-devices" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/510k#term", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "url": "https://medtechterms.com/terms/510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/post-market-surveillance#term", "name": "Post-Market Surveillance", "alternateName": "PMS", "url": "https://medtechterms.com/terms/post-market-surveillance" } ] }, { "@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": "Market Segments", "item": "https://medtechterms.com/terms?cat=Market%20Segments" }, { "@type": "ListItem", "position": 4, "name": "Single-Use Device", "item": "https://medtechterms.com/terms/single-use-device" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Single-Use Device [All terms](/terms) Market Segments [Global Markets](/ecosystems/global-markets)[Strategic Landscape](/ecosystems/strategic-landscape)SUD # Single-Use Device A device the original manufacturer labels for one use or one patient, distinct from reusable devices and from FDA-regulated reprocessed SUDs. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 9, 2026 ## Definition A Single-Use Device (SUD) is one whose original-equipment manufacturer (OEM) [labeling](/terms/labeling) restricts it to a single use or single patient. The Medical Device User Fee and Modernization Act (MDUFMA) of 2002 created a separate regulatory pathway for third-party reprocessors of SUDs: they must obtain their own 510(k) clearance and comply with the same cleaning, [sterilization](/terms/sterilization), and functional-equivalence validation as OEMs. SUDs and reprocessed SUDs are a major sustainability and cost-pressure topic in hospital purchasing. What the regulation says FDA Guidance: 'Reprocessed Single-Use Devices: Termination of Exemptions from Premarket Notification' and the 2018 final guidance on reprocessing validation. 21 USC 360e ( [PMA](/terms/pma)) and 510(k) requirements both apply depending on device class. ## What this means in practice Reprocessed SUDs typically cut device cost 40-60% with no clinical performance difference when properly validated. FDA has cleared reprocessed versions of EP catheters, harmonic scalpels, and orthopedic burrs. Common pitfalls - • Assuming OEM SUD labeling alone prevents a hospital from using a third-party reprocessor, it does not. - • Ignoring environmental and Joint Commission scrutiny of single-use waste streams. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Market Segments Endoscopy Devices Flexible and rigid scopes plus accessories used for visualization, diagnosis, and therapy inside the GI tract, airways, urinary tract, and joints. ](/terms/endoscopy-devices)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance) ### More in Market Segments · Same category [ Market Segments Aesthetic & Energy-Based Devices Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiac Rhythm Management(CRM) Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. ](/terms/cardiac-rhythm-management)[ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Global Markets](/ecosystems/global-markets) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 MedTech Dive· 1 1. [1 FDA, Reprocessing of Single-Use Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/reprocessing-single-use-medical-devices-information-health-care-facilities/reprocessed-single-use-devices-frequently-asked-questions) 2. [2 FDA Guidance, Reprocessing Medical Devices in Health Care Settings (2015) Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-and-labeling) 3. [3 MedTech Dive Verified MedTech Dive · medtechdive.com ](https://www.medtechdive.com/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [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 Market Segments Acronym SUD Sources 3 Updated 5/9/2026 [Compare with another term](/compare?a=single-use-device) Learn in 60 seconds Card Lesson Quiz A device the original manufacturer labels for one use or one patient, distinct from reusable devices and from FDA-regulated reprocessed SUDs. - · Reprocessed SUDs typically cut device cost 40-60% with no clinical performance difference when properly validated. - · FDA has cleared reprocessed versions of EP catheters, harmonic scalpels, and orthopedic burrs. - · SUDs and reprocessed SUDs are a major sustainability and cost-pressure topic in hospital purchasing. Remember this Watch out: Assuming OEM SUD labeling alone prevents a hospital from using a third-party reprocessor, it does not. Related terms - [Endoscopy Devices ](/terms/endoscopy-devices) - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) You may also need Auto-suggested from Market Segments and shared keywords. - [Medhacking ](/terms/medhacking) - [Real-Time PMA Supplement Review ](/terms/pma-real-time-review) - [Cardiac Rhythm Management(CRM) ](/terms/cardiac-rhythm-management) - [Emergency Use Authorization(EUA) ](/terms/eua) - [ISO 15223-1 Symbols ](/terms/iso-15223-1) - [PMA Supplement Types ](/terms/pma-supplement-types) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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