FDA Section 524B cybersecurity compliance services for cyber devices - SPDF, SBOM, postmarket, and CVD.
Every requirement in Section 524B of the FD&C Act - SPDF under 524B(b)(2), SBOM under 524B(b)(3), and postmarket monitoring + coordinated vulnerability disclosure under 524B(b)(1) - built into an eSTAR-ready premarket package. Aligned to the FDA February 2026 final cybersecurity guidance.
Not sure which package fits? Compare in 10 seconds:
510(k) submission
Predicate-based clearance. Cybersecurity section sized to a 510(k) eSTAR.
Premarket, any pathway
Full cyber package for 510(k), De Novo, or PMA. Start here if pathway is TBD.
PMA & De Novo
Higher-risk. Multi-patient harm view + fielded postmarket program at filing.
Section 524B compliance
Cyber device? SPDF + SBOM + postmarket + CVD proven to the 524B statute.
Free 30-min call · Senior US expert · Mutual NDA before the call
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“Blue Goat's niche expertise in FDA-facing cybersecurity made all the difference. Their reports were built with the FDA's expectations in mind-it gave us confidence that we were submitting exactly…”
Scott Odland, Solutions Architect, Rhaeos
Trusted by medical device teams worldwide
Premarket to postmarket. One senior team owns every cybersecurity artifact the FDA reviewer will open.
We confirm whether your device meets the Section 524B(c) cyber device definition and document the rationale for the FDA reviewer.
Vulnerability monitoring sources, severity-based response timelines, CVD policy, patch delivery and rollback - every element reviewers expect.
Secure Product Development Framework integrated into your QMSR (21 CFR 820) and ISO 13485 processes with full traceability.
SPDX or CycloneDX SBOM with NTIA minimum elements (now stewarded by CISA), support-end dates, and a VEX statement for every CVE.
Threat model, security risk assessment, architecture views, and test reports that demonstrate reasonable assurance of cybersecurity.
Every artifact maps directly to the FDA February 2026 final premarket cybersecurity guidance and drops into eSTAR without rework.
Every one of these has triggered an acceptance-checklist hold or a cybersecurity deficiency letter under Section 524B since enforcement began.
The submission doesn't document why the device is (or isn't) a cyber device. Reviewer flags it as missing on acceptance review.
524B(b)(1) requires a coordinated vulnerability disclosure process. Most submissions ship with monitoring sources but no published CVD policy.
Bare SBOM ships with hundreds of unresolved CVEs. Reviewer requires VEX statements for every applicable CVE in the shipping configuration.
Secure Product Development Framework written as a standalone document with no traceability into your 21 CFR 820 / ISO 13485 design controls.
Artifacts exist but no narrative ties threat model, controls, and test evidence into a defensible reasonable-assurance conclusion.
524B requires a plan for software end-of-support. SBOM ships without component-level support windows - immediate reviewer question.
What you actually get versus a generalist regulatory consultant or interpreting 524B clause-by-clause yourself.
| Capability | Blue Goat Cyber | Generalist regulatory consultant | In-house |
|---|---|---|---|
| Section 524B(b)(1)-(4) coverage | Clause-by-clause evidence package | High-level summary, no clause mapping | Engineers translate statute on the fly |
| SBOM + VEX in accepted formats | SPDX or CycloneDX, machine-readable | PDF lists, not reviewer-friendly | Manual export, ages between releases |
| Postmarket plan included | CVD + monitoring program documented | Premarket only, postmarket left open | Often deferred until audit |
| FDA cyber-rejection rate | Zero across 250+ FDA submissions | Variable, often re-submitted | First-submission risk |
| Turnaround | Fixed fee, deadline-aware | Hourly, drifts with scope | Competes with engineering work |
We sign a mutual NDA, then walk your device against the 524B(c) cyber device definition and the evidence the FDA reviewer will expect.
Point-by-point gap list against 524B(b)(1)-(3) and the FDA February 2026 final guidance, plus a fixed-fee quote covering every deliverable.
Cyber device qualification memo, SPDF, SBOM with VEX, postmarket + CVD plan, and the reasonable-assurance narrative - all reviewer-format.
"Blue Goat's niche expertise in FDA-facing cybersecurity made all the difference. Their reports were built with the FDA's expectations in mind-it gave us confidence that we were submitting exactly what reviewers want to see."
If the FDA raises a cybersecurity deficiency, we fix it at no additional cost. 250+ FDA submissions, zero cybersecurity rejections to date.
We sign a mutual NDA before the initial call so you can share device details, architecture, and FDA correspondence freely.
No sales pressure. After the call, you get a concrete written strategy mapped to Section 524B and the FDA February 2026 final guidance.
Senior-led delivery on every FDA-facing artifact. No offshoring, no hourly billing. Unlimited revisions. Every artifact is eSTAR-ready.
Who you're talking to
MBA, CISSP · U.S. Air Force Academy graduate · 30+ years in cybersecurity
Christian leads the senior medical device cybersecurity team behind 250+ FDA submissions, zero cybersecurity rejections. Author of three books including Medical Device Cybersecurity: An In-Depth Guide.
30 minutes with a senior medical device cybersecurity engineer. Mutual NDA signed before the call. No pitch - we'll tell you straight if you don't need us.
How §524B maps to real submission artifacts, SPDF, SBOM, threat modeling, and update mechanisms FDA reviewers now expect.
A subsection-by-subsection walkthrough of FDA Section 524B for cyber medical devices: what §524B(a), (b)(1), (b)(2), (b)(3), (b)(4), and (c) require.
Read the analysisFDA Section 524B applies to any new premarket submission for a cyber device, including legacy platforms.
Read the analysisThe four SBOM elements FDA reviewers verify at RTA screening under Section 524B: format (CycloneDX/SPDX), identifiers (PURL/CPE), vuln disposition, update process.
Read the analysisA short orientation to threat modeling connected and implantable medical devices, with a pointer to the full STRIDE pillar guide for FDA-ready methodology.
Read the analysisSection 524B(b)(1) makes patchability statutory. What the FDA's Feb 2026 guidance expects in the patch and update mechanism test evidence, the test cases.
Read the analysis