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FDA Issues Final Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.

This guidance finalizes the December 2021 draft guidance of the same name and provides industry, investigators, and other stakeholders recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. A DHT is a system that uses computing platforms, connectivity, software, or sensors, for health care and related uses.

This guidance provides recommendations for ensuring that a DHT is fit-for-purpose, which involves considerations of both the DHT’s form and function(s) (design and distinct purpose within an investigation). Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders, and may increase the opportunities for individuals to participate in research and make participation more convenient.

Questions?

If you have questions about this final guidance, contact the Division of Industry and Consumer Education.