Webinars
Effective SBOM Implementation for FDA 510(k): What Medical Device Manufacturers Need to Know in 2026
Event Details
Software Bill of Materials (SBOM) is an integral part of a successful 510(k) submission for medical device manufacturers. As expectations evolve 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, commercial, open-source, and off-the-shelf software component and software management, integration of SBOMs for vulnerability assessment and VEX, and integration of SBOMs in eSTAR submissions and QMS processes.
What You'll Learn
A practical guide to building and maintaining a regulator-ready software bill of materials.
You will learn:
- Be familiar with FDA SBOM requirements outlined in Section 524B of the FD&C Act and the FDA's 2026 cybersecurity guidance.
- Accomplish common commercial, open-source, and off-the-shelf 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 FDA premarket submission 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 updates, patches, and post-market monitoring.
Who Should Attend
- Regulatory Affairs professionals
- Medical device software developers
- Cybersecurity and product security teams
- Compliance and quality assurance professionals
- CTOs, CISOs, engineering leaders, and product security decision-makers
- Organisations preparing for FDA cybersecurity clearance and regulatory submissions
- Teams planning to submit 510(k), De Novo, or PMA applications
- Medical device manufacturers seeking stronger SBOM and cybersecurity readiness
