--- title: "United States FDA 524B - Cybersecurity Submission Playbook" description: "How to submit a medical device to FDA / CDRH in United States: step-by-step route, evidence checklist, common rejections, and typical review timeline. Compare" lang: en json-ld: | [ { "@context": "https://schema.org", "@type": "WebSite", "name": "The Medical Device Cybersecurity Crosswalk", "alternateName": "MDC Crosswalk", "url": "https://mdccrosswalk.com/", "description": "Compare FDA, EU MDR, MHRA, PMDA, NMPA, TGA, MFDS and Health Canada medical device cybersecurity requirements across 29 jurisdictions." }, { "@context": "https://schema.org", "@type": "Organization", "name": "MDC Crosswalk", "url": "https://mdccrosswalk.com/", "logo": "https://mdccrosswalk.com/favicon.png", "sameAs": [ "https://bluegoatcyber.com" ], "description": "An editorial reference comparing global medical-device cybersecurity regulations. Maintained by Blue Goat Cyber." }, { "@context": "https://schema.org", "@type": "Article", "headline": "United States - FDA Premarket Cybersecurity Guidance & FD&C §524B", "description": "How to submit a medical device to FDA / CDRH in United States: step-by-step route, evidence checklist, common rejections, and typical review timeline. Compare", "author": { "@type": "Organization", "name": "MDC Crosswalk" }, "publisher": { "@type": "Organization", "name": "MDC Crosswalk" }, "image": "https://mdccrosswalk.lovable.app/favicon.png", "datePublished": "Feb 2026 (current final guidance)", "about": "U.S. Food and Drug Administration, Center for Devices and Radiological Health", "dateModified": "2026-07-25", "mainEntityOfPage": "https://mdccrosswalk.lovable.app/standards/fda" }, { "@context": "https://schema.org", "@type": "FAQPage", "mainEntity": [ { "@type": "Question", "name": "Is SBOM required for medical devices in United States?", "acceptedAnswer": { "@type": "Answer", "text": "Required. §524B(b)(3): machine-readable SBOM (SPDX or CycloneDX) with known vulnerabilities and support level for each component." } }, { "@type": "Question", "name": "What does FDA / CDRH require for pre-market cybersecurity?", "acceptedAnswer": { "@type": "Answer", "text": "Cybersecurity treated as part of device safety under the QMSR (ISO 13485:2016). Secure Product Development Framework (SPDF) presented as one way to satisfy QMSR. Threat model, SBOM in machine-readable format, security risk management (AAMI TIR57), security architecture views (global system, multi-patient harm, updateability), security testing." } }, { "@type": "Question", "name": "What are the post-market cybersecurity obligations under FDA / CDRH?", "acceptedAnswer": { "@type": "Answer", "text": "Coordinated vulnerability disclosure plan, post-market monitoring, patching commitments and timelines for the supported device lifetime." } }, { "@type": "Question", "name": "What is the penalty for non-compliance with FDA / CDRH cybersecurity rules?", "acceptedAnswer": { "@type": "Answer", "text": "Refusal to Accept (RTA) of submission, adds months to clearance." } }, { "@type": "Question", "name": "How much of my FDA cybersecurity package is reusable in United States?", "acceptedAnswer": { "@type": "Answer", "text": "Roughly 100% - an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report)." } }, { "@type": "Question", "name": "Why do FDA 524B submissions get rejected for \"sbom is a spreadsheet, not machine-readable\"?", "acceptedAnswer": { "@type": "Answer", "text": "Export from your build pipeline as SPDX or CycloneDX; the spreadsheet can be a companion document." } }, { "@type": "Question", "name": "Why do FDA 524B submissions get rejected for \"threat model doesn't map to tested controls\"?", "acceptedAnswer": { "@type": "Answer", "text": "Add a traceability matrix: threat → control → test case → result. Reviewers look for this explicit link." } }, { "@type": "Question", "name": "Why do FDA 524B submissions get rejected for \"no post-market vulnerability monitoring plan\"?", "acceptedAnswer": { "@type": "Answer", "text": "Describe how you will monitor CVEs against your SBOM, patch cadence, and coordinated disclosure contact." } }, { "@type": "Question", "name": "Why do FDA 524B submissions get rejected for \"cybersecurity subsection missing required headings\"?", "acceptedAnswer": { "@type": "Answer", "text": "Mirror the Feb 2026 guidance table of contents verbatim; empty sections with a rationale beat missing ones." } } ] }, { "@context": "https://schema.org", "@type": "HowTo", "name": "How to submit a medical device to FDA / CDRH", "description": "For a cyber device, FDA expects the cybersecurity subsection to stand on its own: a plan, an SBOM, a threat model, security testing, and evidence that your QMS actually produces secure devices. The February 3, 2026 final guidance supersedes the June 2025 version and aligns closely with the QMSR (21 CFR Part 820 / ISO 13485:2016).", "totalTime": "6-9 months for a 510(k) with a clean cybersecurity subsection; 9-15 months with an AI request.", "step": [ { "@type": "HowToStep", "position": 1, "name": "Confirm cyber-device status", "text": "Determine whether the device meets the 524B definition (software + internet-connectable). If yes, the cybersecurity subsection is mandatory, not optional." }, { "@type": "HowToStep", "position": 2, "name": "Build the Secure Product Development Framework (SPDF) record", "text": "Document security requirements, architecture views, threat model, risk controls, security testing, and post-market monitoring plan. FDA reviewers look for traceability from threat to control to test." }, { "@type": "HowToStep", "position": 3, "name": "Assemble the SBOM", "text": "Produce a machine-readable SBOM (SPDX or CycloneDX) covering commercial, open-source, and off-the-shelf software, with support status and known vulnerabilities at time of submission." }, { "@type": "HowToStep", "position": 4, "name": "Draft the Vulnerability Management Plan", "text": "Include coordinated disclosure process, patch cadence, and how you will notify FDA and users of exploitable vulnerabilities post-clearance." }, { "@type": "HowToStep", "position": 5, "name": "Package the cybersecurity subsection", "text": "Follow the section structure in the Feb 2026 guidance exactly. Reviewers use it as a checklist; missing headings trigger an Additional Information request." }, { "@type": "HowToStep", "position": 6, "name": "Submit via eSTAR / eCopy", "text": "eSTAR is mandatory for most 510(k)s. Attach the cybersecurity subsection as its own PDF plus the SBOM as a separate machine-readable file." } ] }, { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://mdccrosswalk.lovable.app/" }, { "@type": "ListItem", "position": 2, "name": "Standards" }, { "@type": "ListItem", "position": 3, "name": "United States" } ] } ] --- [ The Crosswalk ](/) [Overview](/)[Playbook](/playbook)CompareReference [New Per-page social previews and this changelog ](/changelog "Per-page social previews and this changelog") Search⌘K 1. [Home ](/) 2. Standards 3. United States FDA / CDRH # ![Flag of United States](/flags/us.svg)United States - FDA / CDRH Mandatory Last updated · Feb 2026 (current final guidance) Verified · 2026-07-16 FDA Premarket Cybersecurity Guidance & FD&C §524B Share Copy link X LinkedIn Email Sources verified · 2026-07-16 Verified against the FDA Final Guidance issued Feb 3 2026 (PDF, fda.gov/media/119933) and §524B. New title reflects alignment with the QMSR: 'Quality Management System Considerations and Content of Premarket Submissions'. Authority U.S. Food and Drug Administration, Center for Devices and Radiological Health Enforced Mar 2023 Legal framework FD&C Act §524B + Feb 3 2026 Final Guidance, aligned to QMSR (21 CFR Part 820 / ISO 13485:2016, effective Feb 2 2026). Supersedes Jun 2025 guidance and replaces 2014 premarket cybersecurity guidance. FDA package reuse ~100% [Editorial estimate · how →](/methodology#fda-reuse) ## Scope All cyber devices: software in or as a device, with internet connectivity, that could be vulnerable to cybersecurity threats. Applies to 510(k), De Novo, PMA, HDE and BLA submissions. Pre-market Cybersecurity treated as part of device safety under the QMSR (ISO 13485:2016). Secure Product Development Framework (SPDF) presented as one way to satisfy QMSR. Threat model, SBOM in machine-readable format, security risk management (AAMI TIR57), security architecture views (global system, multi-patient harm, updateability), security testing. Post-market Coordinated vulnerability disclosure plan, post-market monitoring, patching commitments and timelines for the supported device lifetime. SBOM Required §524B(b)(3): machine-readable SBOM (SPDX or CycloneDX) with known vulnerabilities and support level for each component. Vulnerability disclosure Mandatory CVD plan submitted with application. Updates must be free of charge. Penalty Refusal to Accept (RTA) of submission, adds months to clearance. ## Unique requirements - 01 Section 524B is statutory, failure = RTA - 02 Architecture views (global system view, multi-patient harm view, updateability view) - 03 Free patches for the device lifetime - 04 Cybersecurity controls must be evidenced through the QMSR / ISO 13485 design controls, not just the submission ## Highlights - Cybersecurity = device safety under QMSR (ISO 13485:2016) - SPDF positioned as one way to satisfy the QMSR - SBOM in machine-readable format - Lifecycle security plan with patch SLAs ## Aligns with IMDRF N60 (Mar 2020) ISO 13485:2016 (via QMSR) AAMI TIR57 NIST SP 800-30 UL 2900-2-1 ## Timeline 1. Dec 2022 Omnibus Act adds §524B to FD&C 2. Mar 29 2023 RTA enforcement begins 3. Sep 27 2023 Final cybersecurity guidance published 4. Jun 27 2025 Final guidance updated (supersedes 2023) 5. Feb 2 2026 QMSR (21 CFR Part 820 / ISO 13485:2016) takes effect 6. Feb 3 2026 Final guidance reissued aligned to QMSR; replaces 2014 premarket cybersecurity guidance and supersedes Jun 2025 version ## Key documents [ Final Guidance (Feb 3 2026): Cybersecurity in Medical Devices - Quality Management System Considerations and Content of Premarket Submissions https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarket ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarket)[ Final Guidance PDF (Feb 3 2026) https://www.fda.gov/media/119933/download ](https://www.fda.gov/media/119933/download)[ Quality Management System Regulation (21 CFR Part 820, effective Feb 2 2026) https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments ](https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments)[ FDA Cybersecurity Hub (Digital Health CoE) https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity ](https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity)[ Cybersecurity in Medical Devices: FAQs https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity-medical-devices-frequently-asked-questions-faqs ](https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity-medical-devices-frequently-asked-questions-faqs)[ Postmarket Management of Cybersecurity in Medical Devices https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices) ## How to submit in United States Playbook reviewed · 2026-07-25 Submission route 510(k), De Novo, or PMA with a cybersecurity subsection under section 524B of the FD&C Act For a cyber device, FDA expects the cybersecurity subsection to stand on its own: a plan, an SBOM, a threat model, security testing, and evidence that your QMS actually produces secure devices. The February 3, 2026 final guidance supersedes the June 2025 version and aligns closely with the QMSR (21 CFR Part 820 / ISO 13485:2016). [Authority portal](https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission) ### Step-by-step 1. Step 01 Confirm cyber-device status Determine whether the device meets the 524B definition (software + internet-connectable). If yes, the cybersecurity subsection is mandatory, not optional. 2. Step 02 Build the Secure Product Development Framework (SPDF) record Document security requirements, architecture views, threat model, risk controls, security testing, and post-market monitoring plan. FDA reviewers look for traceability from threat to control to test. 3. Step 03 Assemble the SBOM Produce a machine-readable SBOM (SPDX or CycloneDX) covering commercial, open-source, and off-the-shelf software, with support status and known vulnerabilities at time of submission. 4. Step 04 Draft the Vulnerability Management Plan Include coordinated disclosure process, patch cadence, and how you will notify FDA and users of exploitable vulnerabilities post-clearance. 5. Step 05 Package the cybersecurity subsection Follow the section structure in the Feb 2026 guidance exactly. Reviewers use it as a checklist; missing headings trigger an Additional Information request. 6. Step 06 Submit via eSTAR / eCopy eSTAR is mandatory for most 510(k)s. Attach the cybersecurity subsection as its own PDF plus the SBOM as a separate machine-readable file. ### Evidence checklist Item Level FDA equivalent Notes Security risk assessment Required 524B(b)(1) Distinct from safety risk analysis; must address confidentiality, integrity, availability. Threat model Required SPDF §V.A.2.2 STRIDE or equivalent, with data-flow diagrams and trust boundaries. SBOM (machine-readable) Required 524B(b)(3) SPDX 2.3 or CycloneDX 1.4+, with support / EOL status per component. Security testing report Required SPDF §V.A.4 Vulnerability scan, penetration test, fuzzing where applicable, static/dynamic analysis. Vulnerability management plan Required 524B(b)(2) Cybersecurity labeling Required SPDF §VII Interoperability considerations Recommended — Required if the device exchanges data with other systems. ### Common FDA 524B rejections SBOM is a spreadsheet, not machine-readable Common Fix · Export from your build pipeline as SPDX or CycloneDX; the spreadsheet can be a companion document. Threat model doesn't map to tested controls Common Fix · Add a traceability matrix: threat → control → test case → result. Reviewers look for this explicit link. No post-market vulnerability monitoring plan Common Fix · Describe how you will monitor CVEs against your SBOM, patch cadence, and coordinated disclosure contact. Cybersecurity subsection missing required headings Occasional Fix · Mirror the Feb 2026 guidance table of contents verbatim; empty sections with a rationale beat missing ones. ### Typical timeline End-to-end window: 6-9 months for a 510(k) with a clean cybersecurity subsection; 9-15 months with an AI request. Phase 01 Pre-submission (Q-sub, optional) 60-75 days Strongly recommended for novel devices or new architectures. Phase 02 eSTAR acceptance review 15 days Phase 03 Substantive review (510(k)) 90 days FDA clock Excludes time on the sponsor for Additional Information responses. Phase 04 Additional Information cycle(s) 30-180 days One AI request is typical; cybersecurity is a top-3 driver of AI requests. [Previous ![Flag of Russia](/flags/ru.svg)Russia ](/standards/ru)[Next ![Flag of European Union](/flags/eu.svg)European Union ](/standards/eu) ## FDA 524B head-to-head [ Compare ![Flag of United States](/flags/us.svg)FDA 524Bvs ![Flag of European Union](/flags/eu.svg)EU MDR Open comparison ](/compare/fda-vs-eu-mdr)[ Compare ![Flag of United States](/flags/us.svg)FDA 524Bvs ![Flag of Japan](/flags/jp.svg)PMDA Open comparison ](/compare/fda-vs-pmda)[ Compare ![Flag of United States](/flags/us.svg)FDA 524Bvs ![Flag of United Kingdom](/flags/gb.svg)MHRA Open comparison ](/compare/fda-vs-mhra)[ Compare ![Flag of United States](/flags/us.svg)FDA 524Bvs ![Flag of Canada](/flags/ca.svg)Health Canada Open comparison ](/compare/fda-vs-health-canada)[ Compare ![Flag of United States](/flags/us.svg)FDA 524Bvs ![Flag of China](/flags/cn.svg)NMPA Open comparison ](/compare/fda-vs-nmpa)[ Compare ![Flag of United States](/flags/us.svg)FDA 524Bvs ![Flag of Australia](/flags/au.svg)TGA Open comparison ](/compare/fda-vs-tga)[ Compare ![Flag of United States](/flags/us.svg)FDA 524Bvs ![Flag of South Korea](/flags/kr.svg)MFDS Open comparison ](/compare/fda-vs-mfds) ## Related markets [![Flag of Canada](/flags/ca.svg) Canada ~95% FDA reuse ](/standards/ca)[![Flag of Israel](/flags/il.svg) Israel ~90% FDA reuse ](/standards/il)[![Flag of United Arab Emirates](/flags/ae.svg) United Arab Emirates ~85% FDA reuse ](/standards/ae)[![Flag of Japan](/flags/jp.svg) Japan ~70% FDA reuse ](/standards/jp) ## Frequently asked about United States ### Is SBOM required for medical devices in United States? Required. §524B(b)(3): machine-readable SBOM (SPDX or CycloneDX) with known vulnerabilities and support level for each component. ### What does FDA / CDRH require for pre-market cybersecurity? Cybersecurity treated as part of device safety under the QMSR (ISO 13485:2016). Secure Product Development Framework (SPDF) presented as one way to satisfy QMSR. Threat model, SBOM in machine-readable format, security risk management (AAMI TIR57), security architecture views (global system, multi-patient harm, updateability), security testing. ### What are the post-market cybersecurity obligations under FDA / CDRH? Coordinated vulnerability disclosure plan, post-market monitoring, patching commitments and timelines for the supported device lifetime. ### What is the penalty for non-compliance with FDA / CDRH cybersecurity rules? Refusal to Accept (RTA) of submission, adds months to clearance. ### How much of my FDA cybersecurity package is reusable in United States? Roughly 100% - an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report). Sponsored note · Blue Goat Cyber Submitting to FDA / CDRH? Get a second pair of eyes before you file. Blue Goat Cyber has packaged cybersecurity evidence for United States alongside 37 other markets. We'll tell you what to keep, what to rework, and what's missing, in 30 minutes. [Talk through your FDA 524B submission](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) The Crosswalk An independent reference for global medical device cybersecurity standards. A field guide for MedTech innovators and RA/QA teams charting an international path. Resource - [Comparison matrix](/compare) - [Global playbook](/playbook) - [Glossary](/glossary) - [FAQ](/faq) Sponsored by [Blue Goat Cyber ↗](https://bluegoatcyber.com) Editorially independent. Sponsorship keeps it free. © 2026 The Crosswalk. Not legal advice. 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