FDA Seeks Comments on Draft Guidance for AI-Enabled Medical Device Software Lifecycle Management

Join Webinar on February 18; Comments due by April 7, 2025

The American National Standards Institute (ANSI) encourages relevant stakeholders to respond to the U.S. Food and Drug Administration (FDA)’s draft guidance on lifecycle considerations for AI-enabled device software functions that will support FDA’s evaluation of safety and effectiveness.

The guidance proposes recommendations for the design, development, and implementation of AI-enabled devices that manufacturers may wish to consider using throughout the total product lifecycle (TPLC).

To give relevant manufacturers and other stakeholders an overview of the guidance, the FDA will host a webinar on February 18.

The draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations, when finalized, is intended to: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 TPLC approach to the management of AI-enabled devices, including providing recommendations for the design, development, 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

While the guidance is open for comments at any time, to ensure that the FDA considers comments before it begins work on the final version of the guidance, submit either online or written comments before April 7, 2025. Access more information and register for the webinar.