Medical Device Cybersecurity Following FDA’s 2026 Premarket Guidance
Cybersecurity is now a central part of FDA’s review expectations for many connected, software-enabled, and networked medical devices.
Speaker
Edwin Waldbusser
Medical device consultant · 20 years in medical device development
Overview
Cybersecurity is now a central part of FDA’s review expectations for many connected, software-enabled, and networked medical devices. Since Section 524B of the FD&C Act became applicable to cyber-device submissions in 2023, manufacturers have had to think beyond traditional software documentation and show how cybersecurity risks will be identified, controlled, monitored, updated, and communicated throughout the device lifecycle.
FDA’s cybersecurity expectations have also continued to move quickly. The 2025 guidance brought additional focus to Section 524B and cyber-device submission expectations, while FDA’s current February 2026 guidance now serves as the latest reference for cybersecurity quality management considerations and premarket submission content. For regulatory, quality, software, and product teams, this means cybersecurity can no longer be handled as a late-stage add-on or left only to IT, hospital networks, or postmarket response teams.
This is where many manufacturers struggle. A submission may include software documentation, risk analysis, and design information, but still fail to clearly connect the threat model, security risk analysis, safety impact, SBOM, update process, vulnerability monitoring, transparency information, and user communication. When those pieces are not aligned, cybersecurity questions can create review delays, documentation gaps, and avoidable remediation work.
This webinar will help attendees understand how to approach medical device cybersecurity following FDA’s current 2026 premarket guidance. The session will explain how cyber risks are identified and mitigated, how security risk should connect with safety risk, how STRIDE analysis can support threat modeling, and how SBOM, transparency, documentation, postmarket monitoring, and update planning fit into a practical cybersecurity program.
Why attend: FDA’s medical device cybersecurity expectations have moved beyond general awareness. For connected, software-enabled, networked, and updateable devices, manufacturers now need to show how cybersecurity risks are identified, analyzed, mitigated, documented, monitored, and communicated throughout the device lifecycle. This creates practical pressure for regulatory, quality, software, product, and compliance teams preparing or supporting premarket submissions. Many organizations struggle because cybersecurity work is often spread across different teams. Engineering may handle threat modeling, quality may manage risk documentation, regulatory may prepare the submission, and postmarket teams may handle vulnerability monitoring and updates. If these pieces are not connected clearly, the submission may leave FDA with unanswered questions about security risk, safety impact, SBOM, transparency, update processes, and user communication. This webinar will help attendees understand how FDA’s current cybersecurity expectations apply in real-world premarket submission planning. Attendees will gain a clearer view of how to structure cybersecurity documentation, connect security risk with safety risk, use threat modeling such as STRIDE appropriately, prepare for SBOM and transparency expectations, and avoid common gaps that can lead to review delays, remediation work, or weak inspection and submission evidence.
What’s covered
- FDA guidance, regulation, and Section 524B legislation
- Cybersecurity planning for medical devices
- Security risk management and safety risk management
- Risk-based analysis of vulnerabilities, threats, and mitigations
- Threat modeling, including STRIDE analysis as a practical method
- Software Bill of Materials requirements
- Cybersecurity documentation for premarket submissions
- Risk communication to users
- Transparency requirements
- Postmarket monitoring and update processes
- Postmarket cybersecurity requirements
Who should attend
What you get
About the speaker
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
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