 
Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. The draft guidance includes lifecycle considerations for AI-enabled devices, as well as specific recommendations to support marketing submissions for these devices.
Facts about the draft guidance
This draft guidance, when finalized, is intended to:
- Recommend the documentation and information to include in a marketing submission to the FDA if a device has one or more AI-enabled software functions.
- Support a Total Product Life Cycle (TPLC) approach to the management of AI-enabled devices, including providing recommendations for the design, development, deployment, and maintenance of AI-enabled devices.
- Help sponsors of AI-enabled devices to identify other relevant guidances to assist them with applying the recommendations in those guidances to AI-enabled devices and support activities throughout the lifecycle of the device.
Note: This guidance is not for implementation at this time.
Submit comments on this draft guidance
Submit comments under docket number FDA-2024-D-4488 at www.regulations.gov by Monday, April 7, 2025 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Upcoming webinar on this guidance
On Tuesday, February 18, 2025 at 2:00 p.m. ET the FDA will host a webinar for manufacturers and others interested in learning more about the guidance.
Questions?
If you have questions about this draft guidance, contact DigitalHealth@fda.hhs.gov. If you have questions about the webinar, contact the Division of Industry and Consumer Education.
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