MedTech Cybersecurity Standards

FDA guidance, AAMI consensus standards, ISO quality and risk frameworks, IEC software lifecycle, NIST cybersecurity controls - they overlap, conflict in places, and together define what reviewers expect. This hub maps the standards landscape and links each one to the services and guides that operationalize it.

Services

• Full-Service FDA Premarket Cybersecurity

  Full-service, end-to-end: we deliver 100% of the artifacts FDA reviewers expect for 510(k), De Novo, PMA, PDP, and HDE submissions under §524B, plus IDE applications under 21 CFR 812 and the FDA's February 3, 2026 premarket guidance - traceable, complete, and current.

• FDA Postmarket Cybersecurity

  Once cleared, your device still needs eyes on it. We handle SBOM monitoring, coordinated vulnerability disclosure, patching, and FDA-aligned reporting - delivered as one-off projects or as an annual TPLC Partnership covering an entire product line.

• Medical Device Threat Modeling

  Comprehensive threat modeling per FDA Section V.A.1 - covering supply chain, deployment, environment of use, and decommission risks for the full device system.

• FDA-Compliant SBOM Services

  Machine- and human-readable SBOMs with NTIA minimum elements (now stewarded by CISA), vulnerability mapping, and end-of-support tracking - built for FDA review.

In-depth guides

• The MedTech Cybersecurity Standards DecoderA plain-English field guide to FDA Section 524B, IEC 81001-5-1, AAMI TIR57, ANSI/AAMI SW96, ISO 14971, and 8 more medical device cybersecurity standards, what they require, how they connect, and what FDA expects in your eSTAR premarket submission.
• The SPDF PlaybookA practical, ungated guide to building a Secure Product Development Framework (SPDF) that FDA accepts, the eight pillars, the artifacts each one produces, and a pre-submission readiness checklist you can score yourself against.
• EU MDR vs FDA Medical Device Cybersecurity: A Side-by-Side CrosswalkHow EU MDR/IVDR cybersecurity requirements compare to FDA Section 524B and the February 2026 guidance - Annex I §17.2, MDCG 2019-16, SBOM, vulnerability handling, and postmarket obligations.
• EU AI Act vs FDA AI/ML Cybersecurity for DevicesHow EU AI Act Article 15 obligations compare to the FDA's PCCP framework and Section 524B for AI/ML SaMD.

Standards & guidance

Defined entries from our MedTech Cybersecurity Standards Glossary.

• FDA 2026 GuidanceFDA Premarket Cybersecurity Guidance (Feb 3, 2026)The FDA's final premarket cybersecurity guidance, effective February 3, 2026. Defines the seven-section cybersecurity submission format reviewers now enforce at Technical Screening, replacing the 2023 draft. Operationalizes Section 524B of the FD&C Act.
• Section 524BFD&C Act Cyber Device RequirementsSection 524B of the FD&C Act (the statutory partner to 21 CFR 807.81) was added by the Consolidated Appropriations Act, 2023. It gives the FDA explicit authority to require a complete cybersecurity package in every premarket submission for a cyber device, and to refuse submissions that lack one. It works alongside 21 CFR 807.81, which sets the 90-day 510(k) filing floor.
• ANSI/AAMI SW96Medical Device Security Risk ManagementThe consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.
• AAMI TIR57Principles for Medical Device Security - Risk ManagementThe MedTech-specific extension of ISO 14971 for cybersecurity. Defines how to identify cybersecurity assets, threats, and vulnerabilities, then estimate, evaluate, and control the resulting risk.
• AAMI TIR97Postmarket Security Risk ManagementPostmarket companion to TIR57/SW96 - CVE monitoring, vulnerability triage, patching, and coordinated disclosure.
• ISO 13485Medical Device Quality Management SystemThe international QMS standard for MedTech. Covers design controls, document control, CAPA, supplier management, and post-market surveillance. The QMSR final rule (effective Feb 2, 2026) harmonizes 21 CFR Part 820 with ISO 13485.
• ISO 14971Medical Device Risk ManagementThe umbrella risk-management standard for medical devices. Defines hazard identification, risk estimation, risk evaluation, risk control, and residual risk evaluation. Cybersecurity risks must be reconciled here so a security control never silently introduces a safety hazard.
• IEC 81001-5-1Health Software Security ActivitiesThe international standard the FDA points to for the Secure Product Development Framework (SPDF). Defines security activities at each lifecycle stage - planning, requirements, design, implementation, V&V, release, and post-market.
• IEC 62443-4-1Secure Product Development LifecycleIndustrial-strength secure-development-lifecycle requirements applied to connected medical devices.
• NIST CSF 2.0Cybersecurity FrameworkSix functions: Govern, Identify, Protect, Detect, Respond, Recover. Not MedTech-specific, but commonly used by health-system customers as their procurement bar - so device makers need to map their controls to it.
• eSTARElectronic Submission TemplateFDA's mandatory interactive submission template with structured upload slots for each cybersecurity artifact.
• SPDFSecure Product Development FrameworkA documented framework that shows security activities are integrated across the device lifecycle - not bolted on at the end. Includes secure requirements, threat modeling, secure coding, V&V, vulnerability management, and post-market response.

From the blog

• AAMI TIR57 Risk Management for Medical Devices
• 21 CFR Part 820 and Medical Device CybersecurityHow 21 CFR Part 820 (and the 2026 QMSR update aligning it to ISO 13485) governs cybersecurity: design controls, CAPA, document controls, and Section 524B evidence.
• A New Era for Quality and SafetyHow the FDA's QMSR incorporates ISO 13485:2016 and aligns with Section 524B cybersecurity expectations for medical device manufacturers.

Related FDA deficiencies

The deficiency letters reviewers most often write on submissions in this topic area. Each links to the full response playbook.

• Missing Cybersecurity Risk Assessment

  Reviewers cannot find a cybersecurity risk assessment distinct from the ISO 14971 safety risk file, or the integration is unclear.

  Response playbook
• Missing SPDF Documentation

  Reviewers cannot find evidence that your QMS implements a Secure Product Development Framework integrated with design controls.

  Response playbook
• Non-Conformant SBOM

  Your SBOM is missing required minimum elements, transitive dependencies, or is delivered in an unsupported format.

  Response playbook
• Insufficient Secure Boot Evidence

  Reviewers want test evidence that secure boot, signed updates, and root-of-trust controls function as claimed.

  Response playbook

Related topics

Adjacent hubs in the same regulatory lifecycle, with the guides, articles, tools, and questions they cover that this hub does not.

• Software as a Medical Device (SaMD) CybersecurityShares FDA 2026 Guidance, Section 524B, ISO 13485 · Same service track: Full-Service FDA Premarket Cybersecurity

  Software as a Medical Device is a cyber device whenever it has software and the ability to connect to the internet, which is nearly always.

  • SaMD Cybersecurity FDA Requirements: 2024 Compliance GuideGuideMaster SaMD cybersecurity FDA requirements. Learn premarket submission needs, SBOM standards, and postmarket monitoring for SaMD under Section 524B.
  • SaMD vs SiMD: What Manufacturers Need to KnowArticleLearn the difference between SaMD and SiMD, why it matters for FDA strategy, and how to build secure-by-design medical devices across your product.
  • IEC 81001-5-1 Security Risk Assessment GuideGuideLearn how to implement IEC 81001-5-1 security risk assessments for FDA compliance. Expert guidance on medical device lifecycle security mapping.

  Is my cloud-only software a medical device?

  If it meets the FDA's definition of a 'device' under FD&C Act Section 201(h) and is intended for diagnosis, treatment, prevention, or mitigation of disease, it's SaMD - regardless of whether it ever runs on a hardware device. The IMDRF SaMD framework is the international reference; the FDA's Digital Health Center of Excellence publishes US-specific guidance. If you're unsure, the right move is a regulatory-strategy consult before you've shipped, not after.

  More Software as a Medical Device (SaMD) Cybersecurity FAQs
• IDE CybersecurityShares FDA 2026 Guidance, Section 524B, ANSI/AAMI SW96 · Same service track: Full-Service FDA Premarket Cybersecurity

  Section 524B(a) does not list IDEs, so the statute's premarket cybersecurity content requirements do not attach to an investigational device exemption.

  • IDE Cybersecurity Requirements: The Investigational Device Guide (2026)GuideWhat cybersecurity documentation an IDE application needs under 21 CFR 812 and the FDA February 3, 2026 premarket guidance, and why Section 524B does not apply.
  • FDA IDE Cybersecurity Requirements: 2026ArticleWhat the FDA's Feb 2026 guidance recommends for IDE cybersecurity: informed consent, architecture views, SBOM, labeling, and what's not required yet.
  • Pathway crosswalkToolCompare what IDE, 510(k), De Novo, and PMA each expect on cybersecurity evidence.

  Does Section 524B apply to IDE submissions?

  No. Section 524B(a) enumerates 510(k), De Novo, PMA, PDP, and HDE; an IDE is submitted under a different section of the FD&C Act. Cybersecurity still applies through binding regulation: 21 CFR 812.25 requires the investigational plan to describe the device, the methodology, and the risks to subjects, and the February 3, 2026 guidance describes the cybersecurity content FDA expects there. The distinction matters because the content lands in the investigational plan rather than in an eSTAR cybersecurity section.

  More IDE Cybersecurity FAQs
• 510(k) CybersecurityShares FDA 2026 Guidance, Section 524B, ANSI/AAMI SW96 · Same service track: Full-Service FDA Premarket Cybersecurity

  A 510(k) cybersecurity package for a cyber device includes the SPDF narrative, threat model, security risk assessment tied to ISO 14971, machine-readable SBOM with VEX, security architecture views, penetration and vulnerability testing evidence, postmarket monitoring plan with coordinated vulnerability disclosure, and cybersecurity labeling.

  • FDA Premarket Cybersecurity Submission Checklist GuideGuideEnsure your 510(k) or PMA is compliant. Use our checklist for FDA premarket cybersecurity submissions, covering SBOM, threat models, and pen testing.
  • 510(k) Cybersecurity Requirements Every Maker Must MeetArticleFDA 510(k) cybersecurity requirements - threat model, SBOM, testing, postmarket plan - scaled across 510(k), De Novo, and PMA pathways under Section 524B.
  • Letter to File vs SIR vs Special 510(k) crosswalkToolMap a security-relevant change to the right pathway and see the cybersecurity evidence each decision requires.

  How is 510(k) cybersecurity different from De Novo or PMA?

  The seven-section cybersecurity package the FDA expects is the same across 510(k), De Novo, and PMA - the differences are scope and depth. 510(k) reviewers focus heavily on substantial equivalence to a predicate, so the threat model and risk assessment have to show that any new connectivity, software, or interfaces don't change the safety profile in a way the predicate didn't address. PMA goes further on manufacturing and quality-system evidence; De Novo allows special controls that can include cybersecurity-specific requirements.

  More 510(k) Cybersecurity FAQs

Get FDA cleared without the cybersecurity headaches.

30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.