The Food and Drug Administration (FDA) has released a draft of new guidance that details the appropriate use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations of medical products. FDA officials pointed out that, in comparison with intermittent trial interactions, using DHTs to collect consistent metrics from trial participants will improve overall data acquisition and utilization efforts. That aside, caution is still advised in the process of leveraging DHT data, and it remains the responsibility of sponsors and stakeholders to ensure their technology fits the purpose properly.
Digital health technologies present an exciting opportunity in clinical research, and the FDA agrees that the ability to transfer data across extreme geographical differences drastically improves trial participation feasibility for previously inaccessible populations. In discussing regulatory considerations, the agency said that DHT use in medical product trials would usually be exempt from marketing authorization or other requirements based on the type of device. Other outlined guidance in the draft includes notes on technology selection and risks, record protection and retention, using tools to collect data for clinical endpoints, and verification, validation, and usability of the technology.
In the past year, the FDA has mainly made headlines for releasing several draft recommendations and "guiding principles" to bring transparency to the rapidly growing medical device sector. Its finalized Content of Premarket Submissions for Device Software Functions from November 2021 would replace existing guidance that is over 16 years old.