Connected medical devices increasingly share third-party and open-source components. A single vulnerability in a widely used library can ripple across vendors and product lines—making Software Bills of Materials (SBOMs) essential for transparency, risk assessment, and incident response across the total product lifecycle. The International Medical Device Regulators Forum (IMDRF) formalized this with its final guidance, “Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity (N73)”, which describes what an SBOM is, how to generate and maintain it, and how healthcare delivery organizations should consume it.
What an SBOM is—and why devices need one
The U.S. National Telecommunications and Information Administration (NTIA) defines an SBOM as a structured inventory of software components and their metadata—the “ingredients list” of a product. This transparency helps manufacturers and operators quickly identify exposure when new vulnerabilities (e.g., in a dependency) are disclosed, and it enables repeatable vulnerability and patch management processes.
IMDRF’s SBOM guidance (N73) dovetails with earlier IMDRF N60 lifecycle cybersecurity practices, positioning SBOMs as part of customer security documentation and post-market risk management. For device makers, that means SBOMs aren’t a one-time deliverable but a maintained asset that evolves with software updates, configurations, and component end-of-support.
Where regulators are today (and what they expect)
In the U.S., the FDA’s final cybersecurity guidance (2025 update) integrates SBOM expectations into quality system and premarket documentation, alongside processes for vulnerability handling, threat modeling, and update mechanisms. The FDA’s public Cybersecurity FAQs also explain how statutory changes (section 524B) affect submissions and postmarket obligations. Manufacturers should expect reviewers to look for SBOM content that’s actionable (e.g., component versions, known vulnerabilities, support status) and kept current throughout the device lifecycle.
Beyond healthcare, CISA’s 2024 framing for software component transparency shows how SBOM data is converging toward interoperable formats and exchange models—useful for scaling supplier management and incident response across complex portfolios and hospital networks.
Practical SBOM essentials for medical-device teams
Per IMDRF N73, an effective medical-device SBOM should clearly identify each component (and transitive dependency), the supplier, version, and unique identifiers, along with relationships and license data. It must also be consumable by customers: documentation should explain how the SBOM is accessed, how frequently it is updated, and how customers can map vulnerabilities to affected configurations. Manufacturers should align SBOM scope and format with their post-market cybersecurity processes so that vulnerability intake (e.g., from CISA/NVD) triggers internal triage, risk evaluation, and—when needed—field actions.
SBOMs for AI/ML and ML-enabled devices (MLMD)
AI-driven devices and machine learning-enabled medical devices (MLMD) depend on extensive software stacks plus data pipelines. While model artifacts aren’t “software components” in the classic sense, the IMDRF MLMD terminology (N67) and broader cybersecurity guidance support the same principle: maintain transparent, version-controlled inventories of the components your safety depends on—frameworks, libraries, runtimes, and security-relevant configs—so you can evaluate and communicate risk when dependencies change. Pair your SBOM with rigorous change control for models and data to preserve safety and performance.
How SBOMs reduce time to action
When a widely used component is found vulnerable, organizations that maintain current, machine-parsable SBOMs can immediately answer: Where do we run this? Which devices are impacted? What versions are affected? That shortens the path from disclosure to containment, patching, or compensating controls—reducing patient and business risk. FDA reviewers, hospital security teams, and incident-response coordinators increasingly expect this level of traceability.
Bottom line for digital-health manufacturers
Treat the SBOM as a first-class safety artifact: build it as you build your software, keep it up to date, make it accessible to customers, and wire it into vulnerability management and field-action playbooks. Align content and exchange formats with IMDRF N73 and be prepared to show how SBOMs underpin your premarket claims and postmarket responsiveness.
If you’re planning or executing a submission, MDx CRO can map your current secure-development and post-market processes to the latest expectations, align SBOM tooling and content to IMDRF/FDA, and integrate SBOM handling into your PMS and incident-response procedures.
