Latest / The Med Device Cyber Podcast
What Is Required for an FDA Pre-Market Cyber Submission?
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…
The skinny
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