FDA Seeks Input on Digital Health Technologies in Clinical Investigations for Drugs and Biological Products April 8, 2026 By Adrienne R. Lenz, Principal Medical Device Regulation Expert —

https://www.thefdalawblog.com/2026/04/fda-seeks-input-on-digital-health-technologies-in-clinical-investigations-for-drugs-and-biological-products/?utm_source=rss&utm_medium=rss&utm_campaign=fda-seeks-input-on-digital-health-technologies-in-clinical-investigations-for-drugs-and-biological-products FDA recently issued a Federal Register notice (Docket No. FDA-2026-N-2476) announcing a request for information and comments titled Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products. A digital health technology (DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses. There were several goals for enhancing use of DHTs to support drug development and review as part of PDUFA VII. In the first year of PDUFA VII (FDA FY 2023) we saw significant progress on these DHT goals, as we blogged about here. In late 2023, FDA finalized its guidance on use of DHTs for remote data acquisition in clinical investigations, which we blogged about here and in June 2024, FDA held its second of five public meetings or workshops. Recently, however, discussion of DHTs at the Agency has been relatively quiet.