Federal Register #FDA-2026-N-2476

FDA Request for Information on Digital Health Technologies in Clinical Investigations

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking input on the use of digital health technologies (DHTs) in clinical investigations for drugs and biological products. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER) - Center for Biologics Evaluation and Research (CBER) - OEMs and Vendors: - No specific OEMs or vendors named; the notice is open to DHT manufacturers, sponsors, and other interested parties - Products/Services Requested: - No procurement of products or services; this is a Request for Information (RFI) and comments - Seeking feedback on DHTs such as wearable, implantable, ingestible, and contactless sensors, mobile applications, and machine learning algorithms - Unique or Notable Requirements: - Input on opportunities and challenges for remote data acquisition and innovative clinical endpoints - Feedback will inform FDA guidance, public workshops, and regulatory frameworks for DHT use in drug and biological product development - Focus on regulatory, technical, and operational considerations for DHT adoption in clinical research

Description

The FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are seeking information and comments on the use of digital health technologies (DHTs) in clinical investigations for drugs and biological products. This request aims to understand the opportunities and challenges faced by sponsors and interested parties in using DHTs for remote data acquisition and innovative clinical endpoints. The feedback will inform FDA activities, including guidance development and public workshops, to support the appropriate use of DHTs in drug and biological product development.

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