Introduction
The Food and Drug Administration (FDA) has unveiled its final guidance on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” This comprehensive guidance provides valuable recommendations for industry professionals, investigators, and other stakeholders. It aligns with the requirements outlined in section 3607(a) of the Food and Drug Omnibus Reform Act of 2022 (FDORA). Its primary goal is to address the challenges and opportunities posed by utilizing Digital Health Technologies (DHTs) for remote data acquisition in clinical investigations evaluating medical products.
Unlocking Efficiency and Accessibility
The guidance emphasizes the potential of DHTs. One of the key advantages is the ability to remotely collect data from trial participants, offering continuous or more frequent insights into participants’ daily lives. This shift from intermittent trial visits to remote data acquisition streamlines the process and provides a more comprehensive understanding of participants’ well-being.
Key Recommendations
The guidance outlines crucial recommendations aimed at facilitating the seamless integration of DHTs in clinical investigations:
- Selection of DHTs: Guidance on choosing DHTs suitable for clinical investigations.
- Regulatory Submissions: Describing DHTs comprehensively in regulatory submissions.
- Verification and Validation: Ensuring DHTs are fit-for-purpose through validation and verification.
- Data Collection: Utilizing DHTs for collecting data for trial endpoints.
- Risk Management: Identifying and managing risks associated with DHT use during investigations.
- Data Protection: Addressing the retention and protection of data collected by DHTs.
- Roles of Sponsors and Investigators: Clarification on the roles of sponsors and investigators concerning DHT use.
Evolution from Draft to Final Guidance
This final guidance builds upon the draft issued on December 23, 2021, incorporating valuable feedback from the public. Changes include clarification on DHT functions, regulatory considerations for devices, handling participants’ DHTs, and recommendations for handling updates during investigations. These revisions aim to enhance clarity and address emerging concerns in the field.
Looking Forward
In compliance with FDORA, the FDA invites comments on this guidance until February 20, 2024, promising to consider any further revisions deemed appropriate. As the landscape of clinical investigations evolves, the guidance on Digital Health Technologies marks a significant step forward, setting the stage for more efficient and participant-friendly trials.
Visit the official notice to read the complete guidance and for instructions for submitting comments.
