FDA Cyber Readiness Diagnostic Checklist

By Christian Espinosa, MBA, CISSP

Founder & CEO · Blue Goat Cyber

Reviewed by Trevor Slattery

COO · Blue Goat Cyber

Last reviewed: May 1, 2026

Free Guide · Blue Goat Cyber · Updated 2026

CHECKLIST · 1 PAGE · PROSPECT RESOURCE

20-Minute Cyber Readiness Diagnostic Bridge the gap between 'we have a deck' and 'we have a submission'.

This outline mirrors the diagnostic we run on the first call. It surfaces the technical and regulatory gaps a generic sales conversation will not, and tells you whether your device is ready for the scrutiny Section 524B brings.

Device & submission profile Device class, software level of concern, and intended use captured in writing?

Submission pathway (510(k), De Novo, PMA) and target date confirmed?

Predicate or reference device identified, with a cyber gap noted?

Connectivity surface mapped (network, wireless, removable media, cloud)?

Cybersecurity artifact status

SBOM generated and reviewed in the last 90 days?

Threat model authored against the current architecture, not a prior version? Penetration test scoped to the device, not just the company's IT?

ISO 14971 risk file extended to cover cybersecurity risks?

Postmarket plan Coordinated Vulnerability Disclosure plan documented and externally accessible?

Patch and update cadence defined and resourced?

Field-monitoring process for new CVEs in third-party components?

How to read it. If more than two items in any section are unchecked, the gap is structural and unlikely to close inside a normal sprint cycle. The diagnostic call exists to size the work, not to sell it.

NEXT STEP → Book a 20-minute readiness diagnostic and you'll leave with a one-page plan you can share with your team. Book your discovery call: go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session

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This guide is part of Blue Goat Cyber's MedTech cybersecurity library. To apply it to your device program, book a 30-minute strategy session - no cost, no obligation. Or browse all guides.