Interlynk · Medical Device SBOM Compliance
Book Demo →
Machine-readable CycloneDX + SPDX
NTIA minimum elements
VEX-ready
Lifecycle-maintained
FROM DEVICE BUILD → FDA 524B EVIDENCE
Interlynk
Generate · Validate · Monitor · Export
The problem
Section 524B requires manufacturers to submit a software bill of materials for cyber devices, keep vulnerability processes active, and provide evidence that cybersecurity was addressed across the product lifecycle.
The hard part is not producing one SBOM. The hard part is proving it matches the device build, stays current after release, and can be exported when a reviewer asks for the evidence trail.
Interlynk connects generation, validation, vulnerability intelligence, VEX, supplier SBOMs, and reporting so the 524B evidence is ready before the submission deadline.
What FDA expects
Machine-readable SBOM
Generate CycloneDX or SPDX SBOMs with NTIA minimum elements, supplier names, versions, PURLs, hashes, and per-component evidence.
Vulnerability monitoring
Continuously watch every component for new CVEs, enrich findings with EPSS and KEV, and filter applicability with VEX.
Secure-by-design evidence
Map SBOM generation, review, vulnerability response, and supplier evidence into a traceable record for reviewers and auditors.
Audit & submission readiness
Export submission-ready SBOMs, vulnerability summaries, VEX status, and evidence for each device version in one queryable record.
524B checklist
How Interlynk helps
01
Generate
Create deterministic SBOMs from your shipped software and supplier inputs.
02
Validate
Check SBOM completeness, identity quality, and minimum-element coverage before submission.
03
Monitor
Watch every released component for new vulnerabilities and maintain VEX applicability.
04
Report
Export reviewer-ready SBOM, risk, VEX, and evidence packages for each product version.
What is FDA 524B?
FDA 524B is the Food, Drug, and Cosmetic Act cybersecurity requirement for cyber devices. It requires manufacturers to submit a software bill of materials, describe vulnerability handling, and maintain processes that address cybersecurity throughout the device lifecycle.
Yes. FDA 524B requires a software bill of materials for cyber devices as part of premarket submissions, including commercial, open-source, and off-the-shelf software components.
FDA expects a machine-readable SBOM. CycloneDX and SPDX are commonly used formats, and Interlynk can export both for submission and audit workflows.
Interlynk generates and validates SBOMs, monitors vulnerabilities after release, tracks VEX applicability, collects supplier SBOMs, and exports evidence packages for reviewers.