Building Transparency: FDA Experts Offer Essential Tips for Assembling SBOMs in Medical Devices
The recent discussion among experts at the Medtech conference, highlighted by the FDA, underscores the critical importance of the Software Bill of Materials (SBOM) in medical device cybersecurity. Although SBOM generation tools are still in their early stages, the consensus is clear: manufacturers must start working immediately on assembling these documents. The SBOM is now an essential regulatory requirement for “cyber devices” and crucial for managing risks and ensuring patient safety. Experts emphasize the need for simplification, the inclusion of key partners in the process, and attention to the details of the human-readable format, which complements the machine-readable format required by the FDA.