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.