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. 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.

• 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

• Regulatory Affairs Managers
• Regulatory Affairs Specialists
• Regulatory Submission Specialists
• Quality Assurance Managers
• Quality Systems Managers
• Design Quality Engineers
• Software Quality Engineers
• Software Validation Engineers
• Medical Device Software Engineers
• Cybersecurity Engineers
• Product Security Engineers
• Risk Management Specialists
• Design Control Specialists
• R&D Engineers
• Product Development Managers
• Systems Engineers
• Clinical Engineering Managers
• Postmarket Surveillance Managers
• Complaint Handling Managers
• CAPA Managers
• Medical Device Compliance Managers
• FDA Compliance Specialists
• Technical Documentation Specialists
• Premarket Submission Team Members
• Medical Device Consultants specializing in FDA submissions, software, quality systems, or cybersecurity

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.