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    Webinar: FDA Expectations for SBOMs — A Deep Dive with Blue Goat Cyber

    · On-demand

    Synopsis

    This webinar from Blue Goat Cyber delves into the U.S. Food and Drug Administration's (FDA) expectations surrounding Software Bills of Materials (SBOMs) for medical devices. Attendees will gain a comprehensive understanding of how SBOMs fit into the regulatory landscape, particularly in the context of FDA Section 524B. The session will explore the requirements and nuances of providing detailed software component information to the FDA, emphasizing its role in pre-market submissions and overall device security.

    The discussion will cover the critical aspects of generating and utilizing SBOMs, including best practices for identifying software components, managing vulnerabilities, and ensuring compliance with evolving regulatory guidance. Blue Goat Cyber experts will share insights into integrating SBOM generation into existing development and risk management processes, such as those guided by ISO 14971 and IEC 62304. The webinar aims to equip medical device manufacturers with the knowledge to effectively meet FDA expectations for SBOMs, supporting both regulatory approval and the long-term security posture of their devices.

    Key takeaways

    • Understand the FDA's regulatory framework for SBOMs, particularly in the context of Section 524B.
    • Learn how SBOMs contribute to effective medical device cybersecurity and risk management.
    • Discover best practices for generating and maintaining accurate SBOMs, aligning with industry standards like AAMI TIR57.
    • Explore the integration of SBOMs into existing quality management systems and software development lifecycles (IEC 62304).
    • Gain insights into the practical application of SBOMs for pre-market submissions, including eSTAR and SPDF considerations.
    • Identify key challenges and strategies for addressing software vulnerabilities exposed through SBOM analysis.
    • Comprehend the role of SBOMs in the broader context of VEX (Vulnerability Exploitability eXchange) information sharing.
    • Learn how to leverage SBOMs to enhance transparency and trust with regulatory bodies and healthcare providers.
    Ready when you are

    Get FDA cleared without the cybersecurity headaches.

    30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ submissions.