US Cybersecurity
FDA Section 524B cybersecurity: requirements, RTA policy & timeline
FDA Section 524B has required cybersecurity documentation for cyber devices since 29 March 2023, with Refuse to Accept enforced from 1 October 2023. The operative guidance is now the February 2026 revision, which supersedes the June 2025 version and aligns it to the QMSR. An incomplete package can have a submission refused before review.
In force
Deadline timeline
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524B takes effect · passed
Section 524B of the FD&C Act takes effect: cyber devices must include cybersecurity information in premarket submissions.
Applies to: Cyber devices (software + network-capable + exploitable)
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Refuse to Accept policy · passed
FDA begins refusing submissions outright for missing 524B cybersecurity content, rather than working through deficiencies collaboratively.
Applies to: All cyber-device premarket submissions
Source ↗ -
Final guidance issued (now superseded) · passed
FDA finalises 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions', setting out the five expected documentation elements. Superseded by the February 2026 revision.
Applies to: Cyber-device manufacturers
Source ↗ -
Guidance revised and aligned to QMSR · passed
FDA issues 'Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions', superseding the June 2025 final guidance. The technical expectations carry over; the framing moves from the Quality System Regulation to the QMSR and ISO 13485:2016, so cybersecurity evidence is expected to come out of controlled quality-system processes rather than be assembled for the submission.
Applies to: Cyber-device manufacturers
Source ↗
Who’s in scope
- A 'cyber device' — software validated/installed/authorised by the sponsor, able to connect to the internet, with characteristics that could be vulnerable to cyber threats (all three conditions, cumulative)
- All submission pathways: 510(k), PMA, De Novo, HDE, PDP
Exclusions
- Devices that run firmware but never connect to a network may fall outside the 'cyber device' definition — but the connectivity condition catches most modern devices
Unlike the EU regimes on this page, FDA Section 524B has no future deadline — it is fully in force and has been since 2023. The dates that matter are historical but consequential: 524B took effect 29 March 2023, and from 1 October 2023 the FDA can issue a Refuse to Accept decision, declining to review a cyber-device submission that is missing required cybersecurity content. That makes the cybersecurity package a gate, not a graded section — a missing SBOM or threat model can bounce a submission at the door and restart the clock.
The document reviewers work from changed on 3 February 2026, when FDA issued Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, superseding the 27 June 2025 final guidance of nearly the same name. Check which version you are citing — the older one is still widely linked.
The five documentation elements are unchanged: a secure product development framework, a threat model and cybersecurity risk assessment, security architecture views, a machine-readable software bill of materials, and cybersecurity testing evidence. What moved is the frame. The revision landed a day after the QMSR took effect, and its substantive job was to re-anchor the guidance on the QMSR and ISO 13485:2016 instead of the old Quality System Regulation. The practical reading is that FDA expects this evidence to fall out of controlled quality-system processes rather than be assembled once for the submission — which is exactly why the SBOM is the most common friction point. It has to be generated from your actual build and kept current as components change.
Because 524B reaches across the 510(k), PMA, and De Novo pathways, it stacks on top of whatever submission timeline you are already managing. For the documentation detail, see: What documentation FDA Section 524B actually requires.
Last reviewed . Deadlines change — always confirm against the cited primary source.