On October 21, 2024, the U.S. Food and Drug Administration (FDA) announced that the FDA Digital Health Advisory Committee will convene a meeting, on November 20-21,2024 on Total Product Lifecycle Considerations for Generative AI-Enabled Devices.

In particular, the Committee highlighted that a generative artificial intelligence (AI) enabled device refers to a device defined under Section 201(h) of the Federal Food, Drug, and Cosmetic Act in which generative AI methods or models are integral to the device's output or functionality.

Medical devices, including those that incorporate generative AI, may be subject to premarket review based on the degree of risk they present. Devices may be subject to:

• premarket approval when the device risk is high;
• de novo classification request when the device is low to moderate risk and there is no legally marketed predicate device; or
• premarket notification when the device is low to moderate risk and there is a legally marketed predicate device.

The Committee noted the unique challenges of generative AI in medical devices. Firstly, in applying a risk-based approach to classification and determining regulatory requirements. Secondly, challenges relating to determining the types of valid scientific evidence for the FDA's evaluation of the medical device's safety and effectiveness.

Accordingly, the Committee outlined that it will discuss, among other things:

• factors to evaluate the safety and effectiveness of generative AI-enabled devices;
• uses or new applications in existing uses, that have been enabled by generative AI for medical devices; and
• capabilities, strategies and tools, and methods and metrics for post-market monitoring of generative AI-enabled medical devices.

You can read the press release here and the Committee summary here.