The FDA released its first guidance specific to the use of digital health technologies (DHT) in December 2021. This is an important milestone signifying the willingness from the regulators to adopt new digital clinical measurements, especially for remote data collection.
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 study dedicated, research-grade wearable devices. This discussion does not cover questionnaire-based DHTs or BYOD models.
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.