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GUIDANCE DOCUMENT

Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations Draft Guidance for Industry and Food and Drug Administration Staff January 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-4488

Docket Number:
FDA-2024-D-4488
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This draft guidance document provides recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA’s evaluation of safety and effectiveness. The recommendations reflect a comprehensive approach to the management of risk throughout the device total product life cycle (TPLC). To support the development of appropriate documentation for FDA’s assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI-enabled devices that manufacturers may wish to consider using throughout the TPLC.

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