--- title: "MDDS, Medical Device Data System | MedTech Terms" description: "Hardware or software intended to transfer, store, convert format, or display medical device data, generally not actively regulated by FDA after 2017 Cures Act…" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdds#term", "name": "Medical Device Data System", "alternateName": "MDDS", "description": "A Medical Device Data System (MDDS) is hardware or software intended to transfer, store, convert format, or display medical device data without controlling the functions or parameters of any connected medical device. The 21st Century Cures Act (2016) amended Section 520(o) of the FD&C Act to exclude most MDDS functions from the definition of a medical device, meaning FDA does not actively regulate software whose sole purpose is to perform these functions. However, software that interprets data, generates alarms based on data, or controls another device is not MDDS and remains a medical device.", "url": "https://medtechterms.com/terms/mdds", "termCode": "mdds", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/mdds#article", "headline": "MDDS, Medical Device Data System", "description": "Hardware or software intended to transfer, store, convert format, or display medical device data, generally not actively regulated by FDA after 2017 Cures Act amendments.", "url": "https://medtechterms.com/terms/mdds", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/mdds" }, "about": { "@id": "https://medtechterms.com/terms/mdds#term" }, "articleSection": "Software & AI", "inLanguage": "en", "keywords": "Medical Device Data System, MDDS, Software & AI, 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": "2026-06-20", "dateModified": "2026-06-20", "citation": [ { "@type": "CreativeWork", "name": "Changes to Software Policies (Section 3060) Guidance", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-existing-medical-software-policies-resulting-section-3060-21st-century-cures-act", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "FD&C Act §520(o)", "url": "https://www.law.cornell.edu/uscode/text/21/360j", "publisher": { "@type": "Organization", "name": "Cornell Law" } }, { "@type": "CreativeWork", "name": "IMDRF - Software as a Medical Device", "url": "https://www.imdrf.org/working-groups/software-medical-device-samd", "publisher": { "@type": "Organization", "name": "IMDRF" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/samd#term", "name": "Software as a Medical Device", "alternateName": "SaMD", "url": "https://medtechterms.com/terms/samd" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/simd#term", "name": "Software in a Medical Device", "alternateName": "SiMD", "url": "https://medtechterms.com/terms/simd" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/cds#term", "name": "Clinical Decision Support", "alternateName": "CDS", "url": "https://medtechterms.com/terms/cds" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/samd-dtx#term", "name": "Digital Therapeutic", "alternateName": "DTx", "url": "https://medtechterms.com/terms/samd-dtx" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/onc-hti#term", "name": "ONC HTI-1 / HTI-2", "url": "https://medtechterms.com/terms/onc-hti" } ] }, { "@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": "Software & AI", "item": "https://medtechterms.com/terms?cat=Software%20%26%20AI" }, { "@type": "ListItem", "position": 4, "name": "Medical Device Data System", "item": "https://medtechterms.com/terms/mdds" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Software & AI](/terms?cat=Software%20%26%20AI) 6. / 7. Medical Device Data System [All terms](/terms) Software & AI [Software Lifecycle](/ecosystems/software-lifecycle)[Global Markets](/ecosystems/global-markets)MDDS # Medical Device Data System Hardware or software intended to transfer, store, convert format, or display medical device data, generally not actively regulated by FDA after 2017 Cures Act amendments. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition A Medical Device Data System (MDDS) is hardware or software intended to transfer, store, convert format, or display medical device data without controlling the functions or parameters of any connected medical device. The 21st Century Cures Act (2016) amended Section 520(o) of the FD&C Act to exclude most MDDS functions from the definition of a medical device, meaning FDA does not actively regulate software whose sole purpose is to perform these functions. However, software that interprets data, generates alarms based on data, or controls another device is not MDDS and remains a medical device. What the regulation says FD&C Act §520(o) as amended by the 21st Century Cures Act §3060. FDA's ' [Clinical Decision Support](/terms/cds) Software' guidance (2022, final) and 'Changes to Existing Medical Software Policies Resulting from Section 3060' guidance clarify what remains regulated after Cures. ## What this means in practice MDDS classification has significant strategic implications for software vendors. A platform that purely moves and displays data from connected devices may not require FDA submission; the moment it adds analytics that interpret or trigger clinical action, it becomes a regulated [SaMD](/terms/samd). The boundary is enforced narrowly by FDA, even simple thresholding or trending logic typically crosses the line. Manufacturers must document MDDS-vs-SaMD classification logic and version-control any feature changes that could move a product across the boundary. Common pitfalls - • Claiming MDDS for software that interprets data, analytics, alarms, scoring, and clinical recommendations are not MDDS. - • Letting MDDS scope creep without re-evaluation, features added over time can shift the product across the regulatory boundary. - • Confusing MDDS with Clinical Decision Support (CDS), they are different exclusions with different criteria under §520(o). ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI Clinical Decision Support(CDS) Software providing healthcare professionals with knowledge and patient-specific information. ](/terms/cds)[ Software & AI ONC HTI-1 / HTI-2 ONC certification rules adding transparency and risk-management requirements to certified health IT, including AI/predictive DSI. ](/terms/onc-hti)[ Software & AI Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. ](/terms/samd)[ Software & AI Software in a Medical Device(SiMD) Software embedded in or required to operate a hardware medical device. ](/terms/simd) ### More in Software & AI · Same category [ Software & AI AAMI TIR45(TIR45) AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle. ](/terms/aami-tir45)[ Software & AI Adversarial Robustness Resilience of an ML model to inputs deliberately crafted to cause misclassification. ](/terms/adversarial-robustness)[ Software & AI AI/ML-Enabled Medical Device Medical device that uses artificial intelligence or machine learning to perform its intended use. ](/terms/ai-ml-device)[ Software & AI Algorithm Change Protocol(ACP) The detailed procedural section of a PCCP that specifies how planned modifications to an AI/ML model will be developed, validated, and implemented. ](/terms/algorithm-change-protocol) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Software Lifecycle](/ecosystems/software-lifecycle) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 Cornell Law· 1 IMDRF· 1 1. [1 Changes to Software Policies (Section 3060) Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-existing-medical-software-policies-resulting-section-3060-21st-century-cures-act) 2. [2 FD&C Act §520(o) Verified Cornell Law · law.cornell.edu ](https://www.law.cornell.edu/uscode/text/21/360j) 3. [3 IMDRF - Software as a Medical Device Verified IMDRF · imdrf.org ](https://www.imdrf.org/working-groups/software-medical-device-samd) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building software-as-a-medical-device? We help SaMD and AI/ML device teams meet IEC 62304 and the FDA's evolving expectations for software cybersecurity. [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 Software & AI Acronym MDDS Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=mdds) Learn in 60 seconds Card Lesson Quiz Hardware or software intended to transfer, store, convert format, or display medical device data, generally not actively regulated by FDA after 2017 Cures Act amendments. - · MDDS classification has significant strategic implications for software vendors. - · The boundary is enforced narrowly by FDA, even simple thresholding or trending logic typically crosses the line. - · However, software that interprets data, generates alarms based on data, or controls another device is not MDDS and remains a medical device. Remember this Watch out: Claiming MDDS for software that interprets data, analytics, alarms, scoring, and clinical recommendations are not MDDS. Related terms - [Software as a Medical Device(SaMD) ](/terms/samd) - [Software in a Medical Device(SiMD) ](/terms/simd) - [Clinical Decision Support(CDS) ](/terms/cds) - [Digital Therapeutic(DTx) ](/terms/samd-dtx) - [ONC HTI-1 / HTI-2 ](/terms/onc-hti) You may also need Auto-suggested from Software & AI and shared keywords. - [AI/ML-Enabled Medical Device ](/terms/ai-ml-device) - [AAMI TIR45(TIR45) ](/terms/aami-tir45) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Data Governance (AI/ML) ](/terms/data-governance) - [Model Card ](/terms/model-card) - [Total Product Lifecycle(TPLC) ](/terms/tplc) [All Software & AI terms](/terms?cat=Software%20%26%20AI) From the Blue Goat network Related resources and services on this topic. - [ AI SaMD Insights How AI is changing SaMD - risk, regulation, and good machine-learning practice. ](https://ai-samd.com) - [ Med Device Cyber Podcast Conversations with medical device cybersecurity practitioners. ](https://mdcpodcast.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)