Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
Click Here To View This Resource The content of this link is external and not affiliated with this site.
A digital health technology DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses. This guidance provides recommendations for sponsors, investigators, and other interested parties on the use of DHTs for remote data acquisition from participants in clinical investigations evaluating medical products. There is a large spectrum of DHTs available for potential use in a clinical investigation, some of which meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C).
31 December 2021
19 September 2022
All Rights Reserved