What distinguishes the different SLSA levels?

SLSA Level 1 requires only a scripted build process with basic provenance documentation, Level 2 requires a hosted build service that generates signed provenance automatically, Level 3 requires the build environment itself to be hardened and non-falsifiable against tampering, and Level 4, still evolving, adds requirements for hermetic, two-person-reviewed builds. Each level is progressively harder to falsify, moving trust from self-reported claims toward cryptographically verifiable evidence.

Does FDA require SLSA provenance for medical device software submissions?

Not directly, SLSA is not yet explicitly cited in FDA cybersecurity guidance, but it is referenced by CISA's software supply chain security guidance and is accepted as supporting evidence under NIST SSDF practices PS.3 (verify third-party software) and PO.3 (implement supporting toolchains), and manufacturers should expect future FDA guidance updates to reference build provenance concepts as supply chain attacks on software increase.

Why does SLSA matter for medical device manufacturers relying on open-source or third-party components?

Supply-chain compromises where malicious code is inserted into a trusted upstream build (such as the well-documented XZ Utils incident) demonstrate that an SBOM listing a compromised component gives no warning if the component was tampered with during build rather than in its published source, so SLSA Level 2 or higher for first-party builds, plus verifiable provenance from upstream suppliers where available, is currently the strongest practical defense against this class of attack.

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CybersecurityConnected & Cyber-Physical Devices Software LifecycleSLSA /salsa/

Supply-chain Levels for Software Artifacts

OpenSSF framework defining progressive levels of build-system integrity for software supply chain security, focused on tamper-resistance of the build.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

Definition

SLSA (Supply-chain Levels for Software Artifacts) is an Open Source Security Foundation (OpenSSF) specification that defines four progressive maturity levels for the integrity of a software build process. Each level adds requirements: SLSA Level 1 asks for a scripted build and provenance; Level 2 requires a hosted build service that generates signed provenance; Level 3 requires the build environment to be hardened and non-falsifiable; Level 4 (still evolving) requires a hermetic, two-person-reviewed build. SLSA's contribution is provenance, verifiable attestations of how, where, and from what sources an artifact was built.

What the regulation says

Not yet directly cited by FDA, but referenced by CISA's Software Supply Chain Security guidance and accepted as evidence under NIST SSDF practice PS.3 (Verify Third-Party Software) and PO.3 (Implement Supporting Toolchains). Expect SLSA references to appear in future FDA cybersecurity guidance updates.

What this means in practice

SLSA complements SBOM. An SBOM tells you what is inside an artifact; SLSA provenance tells you whether the artifact was built from the sources it claims, in a build environment that wasn't tampered with. For medical device manufacturers concerned about XZ-Utils-style supply-chain compromises, SLSA Level 2+ for first-party builds and SLSA-verifiable provenance from upstream component suppliers is the strongest available defense.

Examples

A medical device manufacturer achieves SLSA Level 2 for their firmware build process by using a cloud-hosted build service that automatically generates and signs provenance attestations for each release.
During a pre-market submission, a medical device developer includes SLSA Level 3 attestations for critical software components, demonstrating that the code was built in a hardened, tamper-resistant environment.
A hospital procurement team requires suppliers of network-connected diagnostic equipment to provide SLSA-verifiable provenance for all included open source libraries, ensuring that these components were built from their stated sources without compromise.

Common pitfalls

•Equating SBOM with supply-chain security, without provenance, an SBOM can be fabricated.
•Targeting SLSA Level 4 immediately, most organizations start at Level 1-2 and progress as their build infrastructure matures.
•Ignoring third-party SLSA provenance when selecting components, the framework's value compounds when consumed and produced.

Frequently asked questions

An SBOM (Software Bill of Materials) tells you what components are inside a software artifact, but it does not tell you whether the artifact was actually built from the sources it claims or whether the build process was tampered with; SLSA (Supply-chain Levels for Software Artifacts) addresses that gap by defining verifiable provenance, cryptographically signed attestations of how, where, and from what source an artifact was built.

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Tier 2Regulator guidance and consensus· 3

Link health: 3 verified· last checked 2026-06-20

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Category: Cybersecurity
Acronym: SLSA
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Updated: 6/20/2026

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OpenSSF framework defining progressive levels of build-system integrity for software supply chain security, focused on tamper-resistance of the build.

·SLSA complements SBOM.
·An SBOM tells you what is inside an artifact; SLSA provenance tells you whether the artifact was built from the sources it claims, in a build environment that wasn't tampered with.
·SLSA's contribution is provenance, verifiable attestations of how, where, and from what sources an artifact was built.

Remember this

Watch out: Equating SBOM with supply-chain security, without provenance, an SBOM can be fabricated.

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