Despite their significant promise, most digital health technologies to date have been developed to serve the young, well-to-do, fitness-oriented users, and self-quantification enthusiasts. The transition of these technologies from direct-to-consumer novelties to medical devices requires an in-depth understanding of the variable and evolving FDA regulatory pathways for digital health.  This presentation will discuss current FDA approaches in regulating digital health technologies, including mobile medical applications, wearables, and clinical decision support software, and best practices and strategies to ensure regulatory and commercial success. In addition, we will discuss available accelerated approval pathways for digital health technologies and the impact of the current market shift toward precision medicine.