The FDA released its first digital health technologies (DHT) guidance in December 2021. This is an important milestone signifying the willingness of the regulators to adopt new digital clinical measurements, especially for remote data collection.
As outlined by the guidance, the FDA encourages sponsors to engage early with the relevant review divisions and/or the qualification programs to discuss the use of DHTs and to leverage existing data and expertise made available by the DHT manufacturer. Most recently, in December 2023, the FDA released the final version of this guidance.
To help sponsors, particularly those new to DHTs, we have developed this practical guide to facilitate the use of DHTs and maximize their benefits to clinical investigations. This guide is focused on sensor-based DHTs, specifically studying dedicated, research-grade wearable devices. This discussion does not cover questionnaire-based DHTs or BYOD models.