Jan 7, 2025·FDA · Draft GuidanceDraftMedium impact
FDA draft guidance on AI-enabled device software functions (2025)
This draft covers lifecycle management and what to include in marketing submissions for AI-enabled device software, including a section on cybersecurity risks specific to AI, such as tampered training data and attacks on model inputs.
What changed
- Names AI-specific threats, including data poisoning and model manipulation, as things to address in the submission.
- Still a draft: the FDA has not finalized it, so treat it as the agency's current thinking, not a requirement.
Action for manufacturers
If your device uses AI, add AI-specific threats to your threat model now so the submission holds up whether or not the draft changes.