FDA Issues Draft Guidance on Development and Marketing of AI-Enabled Medical Devices

The FDA has issued draft guidance that includes recommendations to “support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle.”

The guidance would be the first to “provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers an accessible set of considerations that tie together design, development, maintenance and documentation recommendations to help ensure safety and effectiveness of AI-enabled devices.”

The FDA has already authorized “more than 1,000 AI-enabled devices through established premarket pathways.”

The draft guidance specifically “includes recommendations for how and when, in marketing submissions, sponsors should describe the postmarket performance monitoring and management of their AI-enabled devices. The proposed recommendations reflect a comprehensive approach to the management of risk throughout the device total product life cycle.” It also includes the “FDA’s current thinking on strategies to address transparency and bias throughout the life cycle of AI-enabled devices.”

The publication of this guidance comes on the same day as other draft guidance from the FDA “with recommendations regarding the use of AI to support development of drug and biological products.”