FDA draft guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations

Summary

FDA draft guidance issued January 6, 2025 (docket FDA-2024-D-4488; Federal Register notice January 7, 2025, 90 FR 1154) recommending what marketing submissions for devices with AI-enabled software functions should contain, and proposing design, development and documentation practices across the total product life cycle. When final it will include FDA's thinking on addressing transparency and bias, including evidence that a device performs similarly across demographic groups. Comments were requested by April 7, 2025. It remained a draft as of FDA's AI-enabled devices page current to September 22, 2026.

Key dates

1. January 6, 2025Issued
2. October 16, 2026Checked against sources
3. October 21, 2026Checked against sources

Developments are added when the record is reviewed. Next review: January 15, 2027.

Evidence

Each passage is quoted from its source. The quoted passages are re-checked against the live pages every month.

1. is announcing the availability of the draft guidance entitled "Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations."

   Supports: Draft guidance and title

   will include FDA's current thinking on strategies to address transparency and bias throughout the TPLC of AI-enabled devices

   Supports: Transparency and bias

   Submit either electronic or written comments on the draft guidance by April 7, 2025

   Supports: Comment deadline

   Lifecycle draft guidance; Availability Federal Register / FDA Primary source

2. For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices

   Supports: Issue date

   FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration Primary source

3. Download the Draft Guidance Document Read the Federal Register Notice Draft Not for implementation.

   Supports: Still a draft

   Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations U.S. Food and Drug Administration Primary source

4. Draft Guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations

   Supports: Listed as draft on page current as of September 22, 2026

   Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration Primary source