On January 6, 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance aimed at developers of artificial intelligence (AI)-enabled medical devices. This document offers comprehensive recommendations to ensure the safety and effectiveness of AI-driven devices throughout their entire product lifecycle.

The guidance emphasizes the importance of transparency and the mitigation of bias in AI algorithms. It provides detailed considerations for product design, development, maintenance, and documentation. Additionally, it outlines how developers should describe postmarket performance monitoring and management in their marketing submissions, reflecting a comprehensive approach to risk management.

This draft guidance complements the FDA’s recent final guidance on predetermined change control plans for AI-enabled devices, which offers recommendations on proactively planning for device updates post-market.

Troy Tazbaz, director of the Digital Health Center of Excellence within the FDA’s Center for Devices and Radiological Health, stated, “Today’s draft guidance brings together relevant information for developers, shares learnings from authorized AI-enabled devices, and provides a first point-of-reference for specific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 these devices, from the earliest stages of development through the device’s entire life cycle.”

The FDA encourages developers to engage with the agency early and throughout the development process, utilizing this guidance to inform planning, development, testing, and ongoing monitoring activities.

As of this release, the FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways, underscoring the growing significance of AI in the medical device sector.