Feb 3, 2026·FDA · Guidance supersededWithdrawnMedium impact
FDA 2023 premarket cybersecurity guidance superseded
The September 2023 premarket cybersecurity guidance is superseded by the February 3, 2026 final guidance. Citing the 2023 document in new submissions is now a stale reference.
What changed
- The 2023 guidance is no longer the current expectation.
- Templates that hard-code 2023 section numbers need to be re-baselined.
Action for manufacturers
Search your submission templates and SOPs for '2023' guidance references and update them to the 2026 final guidance.