--- title: "SPDX, SPDX | MedTech Terms" description: "An open SBOM and license-data format published as ISO/IEC 5962:2021. Plain-English Cybersecurity definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/spdx#term", "name": "SPDX", "alternateName": [ "SPDX", "Software Package Data Exchange" ], "description": "SPDX (Software Package Data Exchange) is an open specification, maintained by the Linux Foundation and standardized as ISO/IEC 5962:2021, for communicating software bill-of-materials information including components, licenses, copyrights, and security references. SPDX 3.0 (2024) extends the format with profiles for security, AI/ML, and dataset provenance. It is one of the two SBOM formats explicitly accepted by FDA (the other is CycloneDX).", "url": "https://medtechterms.com/terms/spdx", "termCode": "spdx", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/spdx#article", "headline": "SPDX, SPDX", "description": "An open SBOM and license-data format published as ISO/IEC 5962:2021.", "url": "https://medtechterms.com/terms/spdx", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/spdx" }, "about": { "@id": "https://medtechterms.com/terms/spdx#term" }, "articleSection": "Cybersecurity", "inLanguage": "en", "keywords": "SPDX, SPDX, Software Package Data Exchange, Cybersecurity, 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": "SPDX Specifications", "url": "https://spdx.dev/specifications/", "publisher": { "@type": "Organization", "name": "Linux Foundation" } }, { "@type": "CreativeWork", "name": "ISO/IEC 5962:2021 (SPDX)", "url": "https://www.iso.org/standard/81870.html", "publisher": { "@type": "Organization", "name": "ISO/IEC" } }, { "@type": "CreativeWork", "name": "FDA Cybersecurity Guidance (Sept 2023)", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/sbom#term", "name": "Software Bill of Materials", "alternateName": "SBOM", "url": "https://medtechterms.com/terms/sbom" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/cyclonedx#term", "name": "CycloneDX", "url": "https://medtechterms.com/terms/cyclonedx" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/section-524b#term", "name": "Section 524B of the FD&C Act", "alternateName": "524B", "url": "https://medtechterms.com/terms/section-524b" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/vex#term", "name": "Vulnerability Exploitability eXchange", "alternateName": "VEX", "url": "https://medtechterms.com/terms/vex" } ] }, { "@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": "Cybersecurity", "item": "https://medtechterms.com/terms?cat=Cybersecurity" }, { "@type": "ListItem", "position": 4, "name": "SPDX", "item": "https://medtechterms.com/terms/spdx" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/spdx#faq", "mainEntity": [ { "@type": "Question", "name": "SPDX or CycloneDX - which does FDA prefer?", "acceptedAnswer": { "@type": "Answer", "text": "FDA accepts both equally. Pick whichever your toolchain emits natively." } }, { "@type": "Question", "name": "Can we convert between SPDX and CycloneDX?", "acceptedAnswer": { "@type": "Answer", "text": "Yes. Tools such as cyclonedx-cli and spdx-tools include converters. Both formats can carry the SBOM minimum elements; some lossy mapping occurs on edge fields." } }, { "@type": "Question", "name": "Does SPDX support VEX?", "acceptedAnswer": { "@type": "Answer", "text": "SPDX 3.0 introduces a Security profile that includes vulnerability and exploitability assertions, narrowing the historical gap with CycloneDX VEX." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Cybersecurity](/terms?cat=Cybersecurity) 6. / 7. SPDX [All terms](/terms) Cybersecurity [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)SPDX # SPDX An open SBOM and license-data format published as ISO/IEC 5962:2021. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition SPDX (Software Package Data Exchange) is an open specification, maintained by the Linux Foundation and standardized as ISO/IEC 5962:2021, for communicating software bill-of-materials information including components, licenses, copyrights, and security references. SPDX 3.0 (2024) extends the format with profiles for security, AI/ML, and dataset provenance. It is one of the two [SBOM](/terms/sbom) formats explicitly accepted by FDA (the other is [CycloneDX](/terms/cyclonedx)). What the regulation says FDA's 2023 cybersecurity guidance accepts SPDX as a valid [SBOM](/terms/sbom) format. CISA's SBOM minimum elements (NTIA 2021) are satisfiable in SPDX. SPDX is widely used in government and enterprise settings because it is an ISO/IEC standard and integrates naturally with software-license compliance workflows that pre-date SBOM requirements. ## What this means in practice SPDX is most common in build pipelines that already use it for license compliance (e.g., automotive, aerospace, large enterprise software). For MedTech teams choosing fresh, [CycloneDX](/terms/cyclonedx) is often easier to pair with [VEX](/terms/vex), but SPDX is fully acceptable to FDA and a better fit when license attribution is also a deliverable. Common pitfalls - • Treating SPDX as solely a license-compliance artifact and omitting security-relevant metadata. - • Producing SPDX 1.x or 2.x output when modern tooling expects SPDX 2.3 or 3.0. - • Hand-editing SPDX files instead of generating them from the build - drift is inevitable. ## Frequently asked questions SPDX or CycloneDX - which does FDA prefer? FDA accepts both equally. Pick whichever your toolchain emits natively. Can we convert between SPDX and CycloneDX? Does SPDX support VEX? ## Cross-references ### Used by Things that build on this term. - [ Software Bill of Materials(SBOM) ](/terms/sbom) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Cybersecurity CycloneDX A lightweight, OWASP-maintained SBOM format designed for application security and supply-chain use cases. ](/terms/cyclonedx)[ Cybersecurity Section 524B of the FD&C Act(524B) The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices. ](/terms/section-524b)[ Cybersecurity Software Bill of Materials(SBOM) A machine-readable inventory of all software components, including open-source and third-party libraries, used to build a medical device. ](/terms/sbom)[ Cybersecurity Vulnerability Exploitability eXchange(VEX) A machine-readable statement that explains whether a known vulnerability is actually exploitable in a specific product. ](/terms/vex) ### More in Cybersecurity · Same category [ Cybersecurity AAMI SW96 AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle. ](/terms/aami-sw96)[ Cybersecurity AAMI TIR57 AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management. ](/terms/aami-tir57)[ Cybersecurity AAMI TIR97(TIR97) AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57. ](/terms/aami-tir97)[ Cybersecurity Brainjacking Unauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient. ](/terms/brainjacking) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 Linux Foundation· 1 ISO/IEC· 1 FDA· 1 1. [1 SPDX Specifications Verified Linux Foundation · spdx.dev ](https://spdx.dev/specifications/) 2. [2 ISO/IEC 5962:2021 (SPDX) Verified ISO/IEC · iso.org ](https://www.iso.org/standard/81870.html) 3. [3 FDA Cybersecurity Guidance (Sept 2023) Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Working on medical device cybersecurity? Blue Goat Cyber specializes in MedTech cybersecurity - threat modeling, SBOMs, penetration testing, and FDA premarket submissions. [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 Cybersecurity Acronym SPDX Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=spdx) Learn in 60 seconds Card Lesson Quiz An open SBOM and license-data format published as ISO/IEC 5962:2021. - · SPDX is most common in build pipelines that already use it for license compliance (e.g., automotive, aerospace, large enterprise software). - · For MedTech teams choosing fresh, CycloneDX is often easier to pair with VEX, but SPDX is fully acceptable to FDA and a better fit when license attribution is also a deliverable. - · SPDX 3.0 (2024) extends the format with profiles for security, AI/ML, and dataset provenance. Remember this Watch out: Treating SPDX as solely a license-compliance artifact and omitting security-relevant metadata. Related terms - [Software Bill of Materials(SBOM) ](/terms/sbom) - [CycloneDX ](/terms/cyclonedx) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [Vulnerability Exploitability eXchange(VEX) ](/terms/vex) You may also need Auto-suggested from Cybersecurity and shared keywords. - [Supply-chain Levels for Software Artifacts(SLSA) ](/terms/slsa) - [Manufacturer Disclosure Statement for Medical Device Security(MDS2) ](/terms/mds2) - [FedRAMP(FedRAMP) ](/terms/fedramp) - [Health Information Sharing and Analysis Center(H-ISAC) ](/terms/h-isac) - [NIST Cybersecurity Framework(NIST CSF) ](/terms/nist-csf) - [NIST IR 8473, Cybersecurity Framework Profile for HPH(NIST IR 8473) ](/terms/nist-cswp-35) [All Cybersecurity terms](/terms?cat=Cybersecurity) 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 Cyber Tips Practical, organized tips for medical device cybersecurity teams. ](https://medtechcybertips.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ 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)