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We manage 100% of your FDA cybersecurity submission - SPDF, SBOMs, threat modeling, penetration testing, and all documentation - for 510(k), De Novo, PMA, and IDE clearances.
The short answer
An FDA premarket cybersecurity package covers every Section 524B deliverable the eSTAR template gates on: a Secure Product Development Framework narrative, a threat model with trust boundaries, a security risk assessment traced to ISO 14971 and ANSI/AAMI SW96:2023, a machine-readable SBOM with VEX, security architecture views, penetration and vulnerability testing evidence, a postmarket vulnerability management plan with coordinated disclosure, and cybersecurity labeling. Blue Goat Cyber writes and owns all 18 artifacts for a fixed fee, across 510(k), De Novo, PMA, HDE, and IDE, and answers FDA deficiencies until they close.
275+ Submissions. No Cybersecurity Rejections.
Trusted by leading MedTech companies
The Feb 3, 2026 final premarket cybersecurity guidance and Section 524B(b) define what reviewers expect in your eSTAR cybersecurity attachments. Every artifact below is in scope when we run the full premarket engagement.
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
Most full premarket engagements land between $65k and $150k. One fixed fee covers all 18 Section 524B artifacts, FDA deficiency responses until they close, and unlimited retests. You get the exact number in writing within 24 hours of the scoping call, before you commit to anything.
$65k - $90k
Class II software as a medical device, mobile or web front end, cloud back end, no firmware or radio scope. Single 510(k) pathway.
$90k - $125k
Most connected hardware: embedded firmware plus a companion app and cloud back end, BLE or Wi-Fi, and an OTA update path. 510(k) or De Novo.
$125k - $150k+
Class III and PMA submissions, implantables, surgical platforms, multi-device ecosystems, AI/ML components, or parallel submissions across several products.
IDE-only and single-artifact engagements (threat model alone, SBOM alone) scope below this range. Postmarket monitoring via GoatWatch is quoted separately as an annual subscription. All figures are fixed fees, not estimates, and are confirmed in writing before work starts.
Every full-service fda premarket cybersecurity engagement produces evidence aligned to the regulatory and consensus standards FDA reviewers and notified bodies expect to see - traceable, complete, and ready to drop into your ISO 13485 quality system.
Defines the SPDF, Section 524B submission package, threat modeling, SBOM, security architecture views, and cybersecurity testing every cyber device submission must include.
Statutory requirement that every cyber device 510(k), De Novo, PMA, and IDE submission include a complete cybersecurity package or face Refuse to Accept (RTA).
FDA's mandatory interactive submission template with structured upload slots for each cybersecurity artifact.
End-to-end secure development lifecycle the FDA expects to see referenced and evidenced in every cyber device submission.
The consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.
Foundational risk management standard. Cybersecurity risk is tied directly to patient-safety risk in the 14971 file.
International QMS standard for medical devices. Cybersecurity deliverables are designed to slot into your existing 13485 QMS without parallel paperwork.
Recalls, CISA ICS-MA advisories, and disclosed research that shape what reviewers ask about - and what this engagement is built to cover.
Cyber devices submitted without the §524B(b) artifacts are subject to RTA. The Feb 3, 2026 guidance reaffirmed the threshold and clarified artifact-level expectations - the most common RTA trigger remains a missing or non-traceable SPDF.
CDRH CRLs in this period consistently called out under-scoped pen tests, generic threat models, and SBOMs that omit firmware components. These are the three most common premarket cybersecurity deficiencies we see across pathways.
"Blue Goat Cyber helped us navigate our first end-to-end cybersecurity testing for our wearable medical device. Their communication was excellent, their timeline exceeded expectations, and their report helped us achieve FDA clearance without any additional questions. It was a truly seamless experience."
Got an FDA hold or AI letter? We close cybersecurity deficiencies fast.
View FDA Deficiency ResponseEnd-to-end FDA premarket cybersecurity package for Software as a Medical Device - cloud, mobile, and web SaMD.
View SaMD CybersecurityContinuous compliance, monitoring, and vulnerability response.
View FDA Postmarket CybersecuritySee how this service applies to your specific MedTech segment.
Curated reading for teams working on fda premarket cybersecurity - grouped by format so you can jump to what you need.
Long-form reference reading - architecture, frameworks, and end-to-end how-tos.
Shorter posts on the specific gotchas, deficiencies, and reviewer expectations we see most.
Real engagements: device class, what FDA flagged, and exactly how we closed it.
