FDA 524B
FDA Section 524B
In force.
FDA Section 524B applies to cyber devices that contain software, connect to the internet and could be vulnerable to cybersecurity threats. Section 524B requires an SBOM; FDA guidance provides recommendations for its content and format. Missing cybersecurity documentation can delay FDA review or prevent acceptance.
In build
This page is being written. In the meantime — the homepage carries the argument, and the demonstration carries the proof.