Accelerate FDA 524B Compliance for Medical Devices
RunSafe Security’s Approach to SBOM & Vulnerability Management
Medical device manufacturers face increasing regulatory scrutiny under Section 524B of the FD&C Act. An SBOM alone is not enough. The FDA expects manufacturers to demonstrate:
- A complete, validated SBOM
- A clear understanding of vulnerabilities
- A risk-based remediation strategy
- Postmarket monitoring and response processes
What FDA 524B Requires
524B is more than submitting an SBOM — it is demonstrating control over software risk.
| SBOM | Vulnerability Management Plan | Assurance |
| Live, validated Software Bill of Materials (inventory only; no CVEs or remediation data). | Documented process to identify, assess, prioritize, remediate, and monitor vulnerabilities postmarket. | Evidence of secure development processes and lifecycle cybersecurity controls. |
“From our perspective, adding RunSafe means we have more opportunity to shrink the attack surface and reduce overall risks for our customers since security is now already built into our product.”
How RunSafe Supports 524B Compliance
IDENTIFY – Generate a Compliant SBOM
Complete, validated SBOM ready for FDA submission
- Build-time SBOM generation for embedded systems
- CycloneDX-compliant and aligned to NTIA minimum elements
ANALYZE – Understand Vulnerabilities & Regulatory Risk
Clear, defensible vulnerability posture to support FDA review
- Maps SBOM components to CVEs and vendor advisories
- Assesses exploitability — not just presence
- Determines urgency (patch, mitigate, monitor, accept risk)
- Supports VEX documentation
MITIGATE – Eliminate Exploitation Risk
Demonstrable risk reduction for FDA reviewers
- Makes classes of memory-based vulnerabilities non-exploitable
- Reduces risk when patches are unavailable
- No source code rewrites required
MONITOR – Support Postmarket Cybersecurity Plans
Living vulnerability management program aligned to 524B
- Continuous monitoring for new CVEs
- SBOM diff comparisons between builds
- Integration with GitHub, GitLab, Bitbucket
A Stronger FDA 524B Package
RunSafe provides technical evidence and reporting that supports these elements.
| FDA Package Component | Supported by RunSafe |
|---|---|
| SBOM | ✓ |
| Vulnerability Management Plan | ✓ |
| Threat Model & Cybersecurity Risk Assessment | ✓ |
| Secure Development Practices / Secure Product Development | ✓ |
| Postmarket Cybersecurity Plan | ✓ |
| Vulnerability Disclosure Policy / PSIRT | ** |
| Cybersecurity Labeling / User Documentation | ** |
** Subject to RunSafe customers’ practice
Why RunSafe?
RunSafe helps medical device manufacturers accelerate FDA 524B clearance by transforming SBOMs into actionable cybersecurity evidence. We identify vulnerabilities, assess real-world exploitability, recommend risk-based remediation, and reduce exposure—even before patches are available—so you can demonstrate control, minimize review cycles, and bring safer devices to market faster.
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