While interest in generative artificial intelligence (GenAI) tools across the health care sector has expanded rapidly, there remain open questions on the approach to regulating GenAI-enabled products that may fall within FDA’s jurisdiction, including, but not limited to, medical devices. For purposes of this document, we are using the term “GenAI-enabled device” to refer to a device, as that term is defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in which GenAI methods or models are integral to the device’s output or functionality.
Like artificial intelligence (AI)-enabled products, the capabilities of GenAI-enabled products may offer unique benefits to patients and public health, but also bring new regulatory complexities for FDA to address. As with all medical devices, FDA’s regulatory oversight applies to GenAI-enabled products that meet the definition of a device; such oversight is risk-based, taking into consideration the product’s intended use and technological characteristics. Further, FDA has long promoted a total product life cycle (TPLC) approach to the oversight of medical devices, including AI-enabled devices, and has committed to developing regulatory approaches for these devices using current authorities as well as exploring options that may require new authorities.
This commitment has become increasingly relevant for medical devices incorporating technologies that are intended to iterate faster and more frequently over a device’s life of use than ever before. GenAI-enabled products can be intended to provide variable outputs for the same inputs, may frequently rely on models that are meant to change rapidly and often, and may query models that are not themselves medical devices. A TPLC approach is likely to
remain important to the management of future, safe and effective GenAI-enabled medical devices. In this executive summary, we focus on FDA’s approach to the oversight of GenAIenabled devices, which shares many similarities with FDA’s approach for AI-enabled devices in general. This executive summary also discusses the risks of GenAI, some of which may be broadly applicable to AI, and current challenges to regulation of AI- and GenAI-enabled devices across the TPLC.
FDA EXECUTIVE SUMMARY FOR THE DIGITAL HEATH ADVISORY COMMITTEE MEETING Total Product Lifecycle Considerations for Generative AI Enabled Devices
November 20 – 21, 2024