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 (SPDX 2.3 and CycloneDX 1.4+), the rejection patterns we see most often in deficiency letters, and how SBOMs feed into postmarket vulnerability management with VEX. Every artifact we ship is machine-readable, cryptographically hashed for tamper evidence, and structured to drop directly into the eSTAR cybersecurity sections without translation. We cover first-party code, third-party libraries, embedded OS and bootloader components, companion mobile apps, and cloud back-end services as a single linked assembly.
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 - 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.
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.
- 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.
- CPE vs PURL for Medical Device SBOMs: Which Identifier and WhenHow 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.
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.
Related FDA deficiencies
The deficiency letters reviewers most often write on submissions in this topic area. Each links to the full response playbook.
- Non-Conformant SBOM
Your SBOM is missing required minimum elements, transitive dependencies, or is delivered in an unsupported format.
Response playbook - Missing CVE / CWE Mapping
Reviewers cannot find the CVE-to-component or CWE-to-weakness mapping that lets them verify your vulnerability posture.
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
SBOMs for Medical Devices - frequently asked questions
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