SBOMs 101: What the FDA Expects and How to Get It Right

SBOMs 101: What the FDA Expects and How to Get It Right

Published: February 18, 2026

Duration: 41:50

SBOMs are one of the most common sources of FDA deficiencies in medical device submissions. Most companies think they're doing it right, but then they get feedback asking for missing components or clarification on what's included.

In this webinar, Christian Espinosa and Trevor Slattery explain what the FDA actually expects in an SBOM and why it's not just about listing third-party libraries. You need to include first-party code too. You need to follow the NTIA minimum elements. And you need to provide it in a machine-readable format like SPDX or CycloneDX.

Trevor walks through the...