FDA-USER-001 info

The SBOM is in a form that can be provided to users continuously

Pack fda-524b 1.0.0

Severity: info
A labelling obligation rather than a submission one, and it reaches past the filing into the product's whole life. It is informational here because a static file cannot demonstrate a continuous process, but a submission that ignores it leaves a gap a reviewer may notice.
Applies to: cyclonedx, spdx
Selector: {"cyclonedx":"$.metadata.component","spdx":"$"}
On an empty selector: fire
The selector names a specific object the assertion inspects. When that object is absent the information the rule exists to check was not supplied at all, which is a stronger failure than supplying it badly. Reporting nothing would make a missing section indistinguishable from a satisfied one.
Fix: Provide or make SBOM information available to users continuously, in machine-readable form. If you use an online portal, keep the links current and accurate.
Source: fda-premarket-2026-02: Section VI.A, labelling
Note: PARTIAL CHECK. The continuity of the process cannot be seen from one file.

Check a file against this

npx stratifypro check sbom.json --pack fda-524b
npx stratifypro explain FDA-USER-001 --pack fda-524b prints this page.