The Mitre Corporation says stakeholders should work together to normalize how software bill of materials (SBOMs) are implemented in a newly published white paper, which also offers mitigations that need buy-in from stakeholders across the medtech industry.
The white paper was produced on behalf of the US Food and Drug Administration (FDA) and comes a year after the agency published guidance on what medical device makers should include in their SBOMs as part of their premarket submissions. (RELATED: FDA premarket cybersecurity guidance clarifies SBOM requirements, Regulatory Focus 28 September 2023)
SBOMs are used to catalogue and track the software components of various products and programs, including medical devices. These tools are seen as a critical component of software supply chain risk management and help ensure companies can respond adequately to any software issues that may affect their products…
