Comparison guide

    SBOM vs CBOM

    SBOM is the statutory requirement under §524B. CBOM is a legacy term from the 2018 FDA draft guidance.

    The details

    Side-by-side breakdown

    DimensionSBOMCBOM
    Full nameSoftware Bill of MaterialsCybersecurity Bill of Materials
    CoverageSoftware components only (libraries, OS, frameworks).Software + hardware + runtime libraries affecting security posture.
    Statutory statusRequired by FD&C Act §524B for every cyber device.Not statutory; a draft-guidance concept that was not carried into final guidance.
    Standard formatsSPDX or CycloneDX, machine-readable.Free-form; no adopted standard.
    FDA expectation (2026)Required deliverable; reviewers run it through NVD lookups.Largely absorbed into SBOM + HBOM; no longer requested as a separate artifact.
    Today's equivalentContinues as the primary inventory artifact.Split into SBOM (software) and emerging HBOM (hardware).
    Guidance

    When to use which

    Generate an SBOM in SPDX or CycloneDX format and keep it machine-readable - reviewers feed it through CVE lookup automation. A PDF SBOM no longer passes review.

    If your device includes commercial hardware modules (radios, SoCs, sensors) with their own firmware, capture them in an HBOM and cross-reference them to the SBOM. This satisfies what reviewers used to ask for under the CBOM label.

    FAQ

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