This draft guidance document provides recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software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To support the development of appropriate documentation for FDA’s assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI-enabled devices that manufacturers may wish to consider using throughout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.