The United States Food and Drug Administration (FDA) released a draft guidance document on January 6, 2025, outlining its recommendations to facilitate the development and marketing of AI-enabled devices across their entire Total Product Life Cycle.
If finalized, this guidance would mark the first comprehensive set of recommendations for AI-enabled devices throughout their total product lifecycle. It aims to provide developers with a clear framework of considerations that integrate design, development, maintenance, and documentation recommendations to ensure the safety and effectiveness of these devices.
Understanding Its Relevance
The FDA, having authorised over 1,000 AI-enabled devices through established premarket pathways, has consolidated its requirements and shared learnings to serve as “the 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,” according to Troy Tazbaz, director of the Digital Health Center of Excellence within the FDA’s Center for Devices and Radiological Health.
This document addresses a variety of considerations related to pre-market and life cycle management for developers and manufacturers of medical devices that feature one or more AI-enabled software functions, including those utilizing machine learning, deep learning, neural networks, and other AI technologies.
The draft guidance offers recommendations on how and when sponsors should present the postmarket performance monitoring and management of their AI-enabled devices in marketing submissions. These recommendations aim to offer a holistic approach to risk management throughout the device’s total product life cycle. The FDA encourages sponsors to engage with the agency proactively and consistently, and to apply this guidance, once finalized, to inform their activities throughout the device’s life cycle, encompassing planning, development, testing, and ongoing monitoring.
This draft guidance also focuses on addressing transparency and bias throughout the lifecycle of AI-enabled devices. It offers specific recommendations aimed at helping sponsors demonstrate that they have effectively managed risks related to bias, along with suggestions for the careful design and assessment of these devices.
The FDA is inviting public feedback on this draft guidance until April 7, 2025. They are particularly interested in comments regarding how well the guidance aligns with the AI lifecycle, whether the recommendations adequately address concerns related to emerging technologies like generative AI, the strategy for performance monitoring (including the use of a performance monitoring plan to mitigate risks for AI-enabled devices), and what information about these devices should be shared with users, as well as the best ways to communicate that information.
The FDA will also host a webinar on February 18, 2025, to discuss the draft guidance in detail.
