The U.S. FDA is requesting public feedback on draft guidance for the use of digital health technologies (DHTs) in drug development. The notice involves the FDA’s CBER and CDER, aiming to clarify how emerging DHT capabilities can be used in clinical studies as technologies mature. The request reflects growing use of devices and software systems to capture outcomes and monitor participants, including wearables and other remote measurement tools. For biotech sponsors, the central issue is generating data that is acceptable for regulatory review—covering endpoints, data integrity, and operational validation. Companies are also watching how FDA guidance may affect study design and the selection of digital endpoints and data quality controls. If guidance tightens or expands acceptable uses, it could shift trial economics by changing what can be decentralized and how quickly outcomes can be captured. The feedback request indicates FDA intent to keep pace with DHT innovation while setting boundaries that protect interpretability and evidentiary standards.