Oct 2, 2014·FDA · Final GuidanceWithdrawnLow impact
FDA's first premarket cybersecurity guidance (2014), now superseded
The FDA's 2014 guidance was the agency's first statement of what cybersecurity content belongs in a premarket submission: a hazard analysis, a list of controls, and a plan for updates. Later premarket guidance replaced it.
What changed
- Introduced the idea that cybersecurity documentation belongs in every submission for a device with network or software connectivity.
- Superseded by the 2023 final premarket guidance and, now, the February 2026 guidance.
Action for manufacturers
Do not cite the 2014 document in new submissions. Use the current February 2026 premarket guidance.