FDA Request for Information: Advancing Digital Health Technologies in Clinical Investigations for Drugs and Biological Products

The FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are issuing a formal Request for Information (RFI) to gather public input on the use of digital health technologies (DHTs) in clinical investigations. DHTs — including wearables, sensors, and mobile health applications used for remote data acquisition — are increasingly shaping how clinical trial data is collected, and FDA seeks to understand both the opportunities and barriers sponsors face when integrating them into drug and biological product development. This initiative stems from commitments made under PDUFA VII, included in the FDA User Fee Reauthorization Act of 2022, which directed CDER and CBER to actively support DHT adoption in drug development. The RFI is intended to inform future FDA guidance, policy, and potential regulatory frameworks governing DHT use in clinical trials. Stakeholders — including pharmaceutical companies, biotech firms, device manufacturers, academic researchers, and patient advocacy groups — are invited to submit comments addressing challenges such as data validation, interoperability, patient usability, regulatory acceptance of DHT-generated endpoints, and cross-border data considerations. The input collected will shape how FDA approaches DHT oversight going forward. This is not a rulemaking action and does not impose new requirements. However, the feedback gathered is expected to directly influence forthcoming FDA guidance documents and regulatory commitments under PDUFA VII, making it a significant opportunity for industry to shape the regulatory landscape for digital clinical trials.

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