Software Bill of Materials (SBOM) is an integral part of a successful 510(k) submission for medical device manufacturers. As expectations evolve in line with the Section 524B and FDA’s guidance on cybersecurity from 2026, organisations need to ensure their SBOMs are accurate, complete and submission ready.

This webinar will cover the practical steps to put into place SBOMs that meet FDA expectations and enhance software supply chain security. Understand documentation of commercial, open-source, and off-the-shelf software, third-party dependent software management, integration of SBOMs for vulnerability assessment and VEX, and integration of SBOMs in eSTAR submissions and QMSR processes. In addition, you will find common SBOM errors that cause FDA holds, tips on managing SBOMs throughout the product lifecycle and actual case studies of successful 510(k) submissions.

What You’ll Learn

This webinar will assist you to:

• Be familiar with FDA SBOM requirements outlined in Section 524B of the FD&C Act and the FDA’s 2026 cybersecurity guidance.
• Accurately document commercial, open-source, and off-the-shelf (OTS) software components within the SBOM.
• Maintain visibility and control over third-party libraries, transitive dependencies, and legacy software components.
• Integrate SBOM data into vulnerability assessments, CVE analysis, and cybersecurity risk management activities.
• Incorporate SBOM documentation into eSTAR submissions and Quality Management System Regulation (QMSR) workflows.
• Avoid common SBOM-related mistakes that frequently lead to FDA deficiency letters and additional review cycles.
• Establish processes to continuously update and maintain SBOMs throughout software releases, updates, and post-market monitoring.
• Use an FDA readiness checklist to verify SBOM completeness, accuracy, and regulatory compliance before submission.

Who Should Attend

• Regulatory Affairs Professionals
• Medical Device Software Developers
• Cybersecurity and Product Security Teams
• Quality Assurance and Compliance Professionals
• CTOs, CISOs, Engineering Leaders, and Product Security Decision-Makers
• Organizations preparing for FDA cybersecurity compliance and regulatory submissions
• Companies planning to submit 510(k), De Novo, or PMA applications
• Medical device manufacturers seeking to strengthen SBOM and cybersecurity readiness