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 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.The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity professionals specializing in providing elite cyber solutions for medical devices. Learn more about securing your product and business from cyber-criminals by visiting https://bluegoatcyber.com If you’re interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-session 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. Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/ Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/ Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/ Blue Goat Cyber on Facebook: https://www.facebook.com/bluegoatcyber/ Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1 Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9 Feedback? Questions? Contact: https://bluegoatcyber.com/contact/ Learn more about Christian Espinosa, buy his books, or invite him to speak on your stage: https://christianespinosa.com/ Christian Espinosa on YouTube: http://www.youtube.com/@ChristianEspinosaOfficial The Med Device Cyber Podcast is your essential resource for medical device cybersecurity. Each episode we dive into the latest threats, solutions, and best practices to protect modern healthcare technology. Whether you're a provider, a manufacturer, or a cybersecurity professional, gain the knowledge to safeguard patient safety by subscribing to the Med Device Cyber Podcast. Subscribe via Spotify: https://open.spotify.com/show/5ol62ROdF6mBfwOFqKFHmh Subscribe via Apple Podcasts: https://apple.co/483OJ9ISubscribe via YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1