A Practical FDA-Aligned Guide To SBOM Management For Medical Device Cybersecurity

As medical devices become increasingly software-driven and interconnected, cybersecurity risk has become a patient safety issue. In response, global regulators particularly the U.S. Food and Drug Administration (FDA) now expect manufacturers to provide and actively use a Software Bill of Materials (SBOM) as part of a comprehensive cybersecurity risk management strategy.

However, many medical device manufacturers stop at creating an SBOM for regulatory submission, treating it as a static document. The FDA views SBOM as a living asset one that supports continuous vulnerability monitoring, post-market surveillance, and risk mitigation throughout the product lifecycle.

At Maven Regulatory Solutions, we help manufacturers move beyond SBOM generation to effective SBOM governance, ensuring alignment with FDA cybersecurity guidance, post-market expectations, and real-world threat landscapes.

What the FDA Expects from SBOM Management

The FDA’s cybersecurity guidance clearly establishes that:

• An SBOM is mandatory for certain regulatory submissions
• SBOMs must support ongoing vulnerability identification and mitigation
• Manufacturers must demonstrate pre-market and post-market cybersecurity risk management
• Cybersecurity controls must be traceable to patient safety and device performance

In simple terms, regulators expect manufacturers to use their SBOM—not just submit it.

Step-by-Step Guide to Using Your SBOM Effectively

Step 1: Align Your SBOM with FDA Cybersecurity Expectations

Before using an SBOM operationally, ensure it aligns with regulatory intent.

Key regulatory expectations include:

• Traceability of software components
• Ability to identify known vulnerabilities
• Documented mitigation strategies
• Evidence of post-market cybersecurity monitoring

Your SBOM should integrate directly with:

• Risk management files
• Secure product development lifecycle (SPDL)
• Post-market surveillance processes

Step 2: Validate SBOM Completeness and Accuracy

An incomplete SBOM creates false confidence and regulatory risk.

A robust SBOM should include:

Best Practice:
Use automated SBOM validation tools to detect missing data, inconsistencies, or naming errors before submission or internal use.

Step 3: Map SBOM Components to Vulnerability Databases

Once validated, SBOM components must be continuously checked against trusted vulnerability sources, including:

• National Vulnerability Database (NVD)
• Public vulnerability advisories
• Industry threat intelligence feeds

Important considerations:

• Avoid false positives by validating component names and versions
• Document cases where no official CPE exists
• Maintain evidence of due diligence in vulnerability tracking

Accurate matching is essential for regulatory defensibility.

Step 4: Prioritize Vulnerabilities Using Risk-Based Criteria

Not all vulnerabilities present equal risk to patients or device performance.

A structured prioritization approach should include:

• CVSS scores for severity
• Exploitability indicators (EPSS)
• Known exploited vulnerabilities (KEV)
• Clinical and operational impact analysis

If vulnerability does not pose immediate patient or system risk, manufacturers must document rationale, compensating controls, and monitoring plans.

Step 5: Implement Continuous Vulnerability Monitoring

The FDA expects SBOM management to be dynamic, not static.

Effective monitoring includes:

• Automated alerts for newly disclosed vulnerabilities
• Periodic reassessment of existing risks
• Integration with post-market surveillance workflows

SBOMs must remain current throughout the device lifecycle, including maintenance, updates, and end-of-life planning.

Step 6: Maintain Clear Documentation and Communication

SBOM-based cybersecurity documentation supports:

• Regulatory submissions and inspections
• Hospital and healthcare delivery organization (HDO) inquiries
• Internal audits and quality reviews

Key documentation should include:

• Vulnerability assessments
• Risk mitigation decisions
• Patch justifications
• Audit trails demonstrating cybersecurity governance

Clear documentation reduces regulatory friction and customer risk concerns.

Step 7: Plan Patch Management and Secure Updates

A strong SBOM program supports proactive patch management.

Manufacturers should:

• Define criteria for when patches are required
• Evaluate regulatory impact (e.g., post-market changes, 510(k) considerations)
• Maintain a vulnerability disclosure and communication process

Patch decisions must balance cybersecurity risk, patient safety, and regulatory compliance.

SBOM-Driven Cybersecurity Lifecycle

Why SBOM Management Matters More Than Ever

Cyber threats targeting medical devices continue to increase in frequency and sophistication. Regulators, hospitals, and patients now expect manufacturers to demonstrate ongoing cybersecurity accountability.

SBOMs are becoming:

• A regulatory expectation
• A procurement requirement
• A patient safety assurance tool

Organizations that invest early in SBOM governance gain long-term resilience.

How Maven Regulatory Solutions Supports SBOM Compliance

Maven Regulatory Solutions provides end-to-end support for:

• FDA-aligned SBOM strategy development
• Cybersecurity documentation and submissions
• Vulnerability risk assessment frameworks
• Post-market cybersecurity governance
• Regulatory intelligence and compliance readiness

We help transform SBOMs from documents into decision-enabling tools.

Conclusion

SBOM is not the final deliverability, it is the foundation of continuous cybersecurity risk management. By implementing a structured, risk-based SBOM management approach, medical device manufacturers can meet FDA expectations, reduce cybersecurity exposure, and protect patients and healthcare systems.

Proactive SBOM governance today prepares organizations for future regulatory scrutiny and evolving cyber threats.

FAQs: SBOM Management for Medical Devices

1. Is an SBOM mandatory for FDA submissions?
For certain device types and software-enabled products, yes.

2. How often should SBOMs be updated?
SBOMs should be updated whenever software components change or new vulnerabilities emerge.

3. What if a vulnerability cannot be patched immediately?
Manufacturers must document risk justification and compensating controls.

4. Does SBOM management apply to the post-market?
Yes. The FDA explicitly expects post-market vulnerability monitoring.

5. Can SBOMs reduce regulatory audit risk?
Yes. Well-managed SBOMs demonstrate proactive cybersecurity governance.