Artificial Intelligence (AI) refers to the capability of algorithms integrated into systems and tools to learn from data so that they can perform automated tasks without explicit programming of every step by a human. Generative AI is a category of AI techniques in which algorithms are trained on data sets that can be used to generate new content, such as text, images or video. This guidance addresses one type of generative AI, large multi-modal models (LMMs), which can accept one or more type of data input and generate diverse outputs that are not limited to the type of data fed into the algorithm. It has been predicted that LMMs will have wide use and application in health care, scientific research, public health and drug development. LMMs are also known as “general-purpose foundation models”, although it is not yet proven whether LMMs can accomplish a wide range of tasks and purposes.