Postmarket Medical Device Cybersecurity

FDA clearance isn't the finish line - it's the start of your postmarket cybersecurity obligations. This hub collects our postmarket service, coordinated vulnerability disclosure (CVD) program guidance, legacy device strategy, and the standards (AAMI TIR97, IEC 81001-5-1, the FDA's postmarket cybersecurity guidance) that define what 'good' looks like in the field. A real postmarket program produces objective evidence at five touchpoints: continuous SBOM and CVE monitoring with weekly VEX triage, a published CVD policy with researcher acknowledgement workflow, a defined patch validation cadence integrated with your release pipeline, FDA reportable event templates and decision trees, and customer advisory communications calibrated for hospital and IDN procurement teams. The reporting cadence we recommend is monthly engineering review, quarterly leadership and audit-ready summary, and annual program assessment under your QMS.

Services

• 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.

• Legacy Device Protection

  Compensating controls, network isolation, and monitoring for fielded devices that can't be easily updated - keeping clinical operations running without touching the cleared design.

• 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

• Postmarket Cybersecurity Readiness PlanA three-phase plan, Premarket → Launch → Operate, for the cybersecurity work that starts before your 510(k) is filed, lights up before your first device ships, and runs for the life of the product. Aligned to the FDA February 2026 final guidance.

Standards & guidance

Defined entries from our MedTech Cybersecurity Standards Glossary.

• AAMI TIR97Postmarket Security Risk ManagementPostmarket companion to TIR57/SW96 - CVE monitoring, vulnerability triage, patching, and coordinated disclosure.
• 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.
• 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.
• 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.

From the blog

• Conducting a Medical Device Security AuditStep-by-step guide for medical device manufacturers to run a cybersecurity audit: scope, threat modeling, SBOM review, testing, and FDA-aligned documentation.
• Medical Device Cybersecurity: 2026 Best Practices GuideThe 12 medical device cybersecurity best practices FDA reviewers expect in 2026: SW96 threat modeling, SBOM with VEX, pen testing, secure updates, and 524B evidence.

Related FDA deficiencies

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

• Inadequate Vulnerability Management Plan

  Your VM plan lacks defined triage timelines, a coordinated vulnerability disclosure path, or a documented patch-deploy mechanism.

  Response playbook
• Inadequate Post-Market Cybersecurity Plan

  Your post-market plan lacks monitoring, patching commitments, customer communications, or end-of-support handling.

  Response playbook
• Non-Conformant SBOM

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

  Response playbook
• Missing SPDF Documentation

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

  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.

• SBOMs for Medical DevicesShares AAMI TIR97, IEC 81001-5-1, Section 524B · Same service track: FDA Postmarket Cybersecurity

  An FDA-acceptable SBOM is machine-readable in CycloneDX or SPDX, covers commercial, open-source, and off-the-shelf software, and carries the metadata reviewers check for: supplier, component name, version, unique identifier, dependency relationship, author, timestamp, support level, and end-of-support date.

  • The MedTech Cybersecurity Standards DecoderGuideA 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.
  • CPE vs PURL for Medical Device SBOMs: Which Identifier and WhenGuideHow CPE and PURL identifiers differ, why medical device SBOMs need both, and how to map PURL to CPE for FDA postmarket CVE monitoring under Section 524B.

  SPDX or CycloneDX - which format should I use?

  Both SPDX 2.3+ and CycloneDX 1.4+ are accepted by the FDA and explicitly endorsed in the 2026 final premarket cybersecurity guidance. CycloneDX has stronger native support for vulnerability data (VEX) and component pedigree, which is why most MedTech teams ship CycloneDX 1.5 today and why we default to it. SPDX is more common in upstream open-source projects and remains a perfectly valid submission format. Pick one, be consistent across your portfolio, and make sure the format is genuinely machine-parseable - reviewers do parse it, and a malformed JSON file is one of the fastest ways to trigger a Refuse To Accept.

  More SBOMs for Medical Devices FAQs
• MedTech Cybersecurity StandardsShares AAMI TIR97, IEC 81001-5-1, Section 524B · Same service track: FDA Postmarket Cybersecurity

  The standards MedTech teams actually need are a short list: ISO 14971 for safety risk management, ANSI/AAMI SW96:2023 for security risk management, AAMI TIR57 as its predecessor and companion, IEC 62304 for software lifecycle, IEC 81001-5-1 for secure development, and UL 2900 series where a certification is contractually required.

  • The MedTech Cybersecurity Standards DecoderGuideA 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.
  • AAMI TIR57 Risk Management for Medical DevicesArticle
  • The SPDF PlaybookGuideA 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.

  Which standards does the FDA actually require?

  The FDA requires compliance with statute (Section 524B) and 21 CFR Part 820 / QMSR. They recognize - but don't strictly mandate - consensus standards like AAMI SW96, IEC 81001-5-1, and ISO 14971. In practice, declaring conformance to those standards is the cleanest path through review.

  More MedTech Cybersecurity Standards FAQs
• Software as a Medical Device (SaMD) CybersecurityShares IEC 81001-5-1, Section 524B, FDA 2026 Guidance · Same service track: FDA-Compliant SBOM Services

  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.
  • EU AI Act vs FDA AI/ML Cybersecurity for DevicesGuideHow EU AI Act Article 15 obligations compare to the FDA's PCCP framework and Section 524B for AI/ML SaMD.

  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

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.