FDA Cybersecurity Premarket Guidance (2025 final guidance — security architecture): Security architecture views expected in a premarket submission

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The FDA's June 2025 final cybersecurity guidance expects a cyber-device submission to include security architecture views — diagrams and descriptions of the device's security design from several angles. The guidance describes a global system view, a multi-patient harm view, an updateability and patchability view, and a security use-case view. Together they show a reviewer how the device is defended, how it is patched, and how a compromise could propagate.

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FDA Section 524B — deadline tracker

Verified 1 June 2026 against the primary source. Standards are periodically revised — always confirm the current text.