FDA's Draft Guidance Support for AI Devices

"FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways", reports Troy Tazbaz, Director Digital Health Center of Excellence within FDA's Center for Devices and Radiological Health. "The draft guidance recently issued brings together relevant information for developers, shares learnings from authorized AI enabled devices, and provides a first point of reference for specific recommendations that apply to devices from the earliest stage of development through the device's entire life cycle."

The Federal Register on January 7, 2025, issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device's life cycle.

The draft guidance if finalized would provide developers with an accessible set of considerations that would tie together design, development, maintenance, and documentation recommendations, to help ensure safety and effectiveness of AI-enabled devices.

FDA is encouraging sponsors to engage with FDA early and often, and to use the guidance once finalized to guide their activities throughout the life cycle of the device, including during planning, development, testing, and ongoing monitoring.

The draft guidance also includes FDA's current thinking on strategies needed to address transparency and bias throughout the life cycle of AI-enabled devices. The draft guidance describes specific recommendations that are intended to help a sponsor demonstrate that they have addressed the risks associated with bias and suggestions for the design and evaluation of AI-enabled devices.

FDA is requesting public comment on the draft guidance by April 7, 2025. In addition to general comments, FDA is specifically requesting public comment on the draft guidance's alignment with AI life cycle, information on recommendations to address concerns that may be raised by emerging technologies such as generative AI, the approach to performance monitoring, type of information about AI-enabled devices that should be conveyed to users, and the most appropriate approach to use to deliver that information.

FDA is going to hold a webinar on February 18, 2025 to discuss the draft's guidance. For more information, contact digitlhealth@fda.hhs.gov and for consumer inquiries, email 888-INFO-FDA.