SBOMs for Medical Devices

An SBOM is now table-stakes for FDA cybersecurity review - and the most common reason packages get rejected at Technical Screening. This hub covers our SBOM service, format guidance, common rejection patterns, and how SBOMs feed into postmarket vulnerability management.

Services

• FDA-Compliant SBOM Services

  Machine- and human-readable SBOMs with NTIA minimum elements, vulnerability mapping, and end-of-support tracking - built for FDA review.

• FDA Postmarket Cybersecurity

  Once cleared, your device still needs eyes on it. We handle SBOM monitoring, coordinated vulnerability disclosure, patching, and FDA-aligned reporting.

• Legacy Device Protection

  Compensating controls, network isolation, and monitoring for fielded devices that can't be easily updated - keeping clinical operations running.

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 the FDA expects to see in your eSTAR premarket submission.
• Postmarket Cybersecurity Readiness PlanFree Guide · Updated 2026 · FDA-Aligned The Postmarket Cybersecurity Readiness Plan Premarket → Launch → Operate What FDA expects, and when. A three-phase plan 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 p

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 RequirementsAdded by the Consolidated Appropriations Act, 2023, Section 524B 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.
• 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.
• AAMI TIR97Postmarket Security Risk ManagementPostmarket companion to TIR57/SW96 - CVE monitoring, vulnerability triage, patching, and coordinated disclosure.

From the blog

• A Guide to FDA Cybersecurity DocumentationFDA cybersecurity documentation requirements (2025): 524B cyber device rules, SPDF, SBOM, threat modeling, testing, and a premarket submission checklist.
• Best Practices for Medical Device CybersecurityMedical device cybersecurity best practices for 2025: threat modeling, SBOM, penetration testing, secure updates, and FDA 524B/SPDF readiness.

Get FDA cleared without the cybersecurity headaches.

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