A digital health technology DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses. This guidance provides recommendations for sponsors, investigators, and other interested parties on the use of DHTs for remote data acquisition from participants in clinical investigations evaluating medical products. There is a large spectrum of DHTs available for potential use in a clinical investigation, some of which meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C).