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 AuditThis post outlines the key steps to perform a comprehensive cybersecurity risk assessment and testing of medical devices.
• 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

Get FDA cleared without the cybersecurity headaches.

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