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Unpacking New FDA Draft Guidance On Digital Health

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In December 2021, The U.S. Food and Drug Administration (FDA) issued new draft guidance on Digital Health Technologies (DHTs) for Remote Data Acquisition in Clinical Investigations. The draft guidance document provides FDA recommendations on the use of DHTs for remote data acquisition in clinical trials. This new guidance follows the increasing demand for decentralized clinical trial elements, a demand that has exploded throughout the COVID-19 (SARS-CoV-2) pandemic. 

The draft document also provides guidance to DHT manufacturers, addressing issues they must be aware of when their products are used for clinical investigations outside the original intended use. The draft guidance touches on regulatory considerations, stating that “DHTs used in clinical investigations of medical products would typically be exempt from applicable requirements to obtain marketing authorization and other device requirements, as long as the clinical investigation is compliant with 21 CFR part 812.”

In addition, the draft guidance addresses some of the information that should be included in an Investigational New Drug application (IND) or an Investigational Device Exemption (IDE) application for a clinical investigation in which the sponsor intends to use one or more DHTs.

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