White Paper

What Does The New FDA DHT Guidance Mean? A Practical Guide For Sponsors

Source: ActiGraph
GettyImages-1139719728 FDA

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.

access the White Paper!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Clinical Leader