What Is Required for an FDA Premarket Cyber Submission? | Ep. 47

Описание: What are the 18 required cybersecurity deliverables for a pre-market submission, and how do they map to eSTAR’s 13 sections?

This episode breaks down the cybersecurity deliverables required for an FDA pre-market submission and explains why they apply consistently across all device types. Christian and Trevor walk through each deliverable in detail, outline how they map to eSTAR v6.0, and highlight common misconceptions that slow down manufacturers.

Key points:

(00:33) Why all devices—high-risk or low-risk—must submit the same 18 cybersecurity deliverables to the FDA.
(01:41) How device complexity influences documentation depth even though the deliverables never change.
(04:42) How the 18 deliverables map to the 13 sections of eSTAR version 6.0.
(09:50) The risk management report, threat model, risk assessment, and SBOM requirements.
(17:41) How to evaluate and categorize unresolved anomalies.
(20:04) How manufacturers should track remediation timelines and vulnerability density.
(23:52) The cybersecurity management plan and the extensive post-market responsibilities expected by the FDA.

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Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Technology Officer / Director of MedTech Cybersecurity at Blue Goat Cyber.

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