Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

On 21 January 2022 the FDA published the draft guidance for industry, investigators, and other stakeholders. Comments may be submitted until 22 March 2022.

This guidance provides recommendations for sponsors, investigators, and other stakeholders on the use of DHTs for remote data acquisition from participants in clinical investigations evaluating medical products.

DHTs may take the form of hardware and/or software and may be used to gather health-related information from study participants and transmit that information to study investigators and/or other authorized parties to evaluate the safety and effectiveness of medical products.

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