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.

In the notice, FDA acknowledges that there have been significant advances in sensor technology and states that they will use the information gathered in the request for information for development of guidance documents and to support other activities related to use of DHTs in clinical investigations of drugs and biological products.

Specifically, FDA seeks responses to the following questions.

1. What regulatory challenges do DHT manufacturers, sponsors or other interested parties face regarding the use of DHTs in clinical investigations of drugs and biological products?
2. What opportunities are there for CDER and CBER to support and facilitate the adoption of DHTs in clinical investigations of drugs and biological products?
3. What areas of guidance would support the use of DHTs in clinical investigations?
4. What specific DHT related topics, such as digitally derived endpoints in certain disease areas, would benefit from discussion in a public workshop?

For sponsors considering, or already implementing, DHTs in clinical investigations, this is a timely opportunity to highlight real‑world challenges and help shape the next phase of FDA policy.  Ultimately, the extent to which DHTs are more fully integrated into drug and biologics development will depend not only on technological advances, but also on regulatory clarity.  Stakeholder engagement in response to this notice—and in any future workshops—will be critical to ensuring that FDA’s framework supports innovation while maintaining data integrity and patient protection.

Interested parties should submit comments by June 1, 2026 following instructions provided in the Federal Register notice.