This short course will provide an overview of device, drug, and combination product regulations with a focus on the application of the existing scheme to digital health products. The course will also cover recent policy developments that have been implemented to assess whether a digital health product is considered a medical device as well as when a premarket application is needed. The course will discuss considerations for combining mobile apps/software with a drug or biologic product to understand the holistic regulatory environment that should be considered for digital health products.