FDA Digital Tech Guidance Aids Clinical Trial Data Collection

Digital health technologies used in clinical trials to track biomarkers, daily performances, vital signs, and other activities won’t need the FDA’s medical device clearance as long as the study meets the agency’s standards, the FDA said Thursday.

The Food and Drug Administration’s final guidance provides recommendations for sponsors, investigators, and others on the use of digital health technologies for remote data collection from participants in clinical investigations.

The use of DHTs has grown due to the increasing advances in technology, which have transformed the ability to remotely collect and analyze clinical information from individuals. DHTs capture and transmit data remotely, ...