The U.S. FDA now requires medical device manufacturers to include a Software Bill of Materials (SBOM) as part of their premarket submissions. These cybersecurity guidelines—outlined in Section 524B of the FD&C Act and related FDA guidance—focus on transparency, vulnerability management, and postmarket response. An SBOM is not just a checkbox item; it’s a central tool for meeting these regulatory and security obligations.
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FDA expects an SBOM to be submitted with every applicable premarket filing. This SBOM must include all third-party and open-source components. Having an accurate, machine-readable SBOM ready helps ensure faster review and acceptance, while demonstrating your commitment to secure-by-design principles in regulated medical devices.
The FDA requires manufacturers to continuously monitor for and address cybersecurity vulnerabilities after a product is on the market. An SBOM enables this by providing a detailed inventory of software components that can be cross-referenced against known vulnerabilities (like CVEs). It streamlines risk triage, remediation, and communication—key to maintaining product safety and compliance.
Manufacturers are expected to respond quickly to emerging threats. In the case of a software vulnerability, knowing exactly which devices and components are affected is critical. An SBOM provides that visibility. It helps security teams assess impact immediately and take informed actions to contain and mitigate the issue, aligning with FDA expectations for rapid response and patient safety.
The FDA’s cybersecurity requirements emphasize transparency, risk management, and traceability. An SBOM acts as a living artifact that documents your proactive cybersecurity posture. It provides auditors and regulators with tangible proof that you monitor and manage the software risks in your devices—supporting both initial approval and ongoing compliance.
Interlynk SBOM Automation Platform is for building products securely, streamlining compliance and eliminating manual steps. Our solution is designed to be cost-effective and efficient, saving you valuable time and resources.
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