FDA releases guidance for remotely acquiring data in clinical investigations

The U.S. Food and Drug Administration has released a draft guidance focused on using digital health technologies to acquire data remotely from participants in clinical investigations of medical products. "Compared to intermittent trial visits, the use of DHTs to remotely collect data from trial participants may allow for continuous or more frequent data collection," said FDA officials. The FDA notes that digital health tools used for remote data acquisition can offer an important role in clinical research. The draft guidance touched on regulatory considerations, noting that DHTs used in clinical investigations of medical products would usually be exempt from applicable requirements to obtain marketing authorization and other device requirements. "As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices," said Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and Radiological Health, in a statement in November. "The draft guidance, when finalized, will represent the current thinking of FDA on 'Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,'" they said.