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FDA Draft Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

  • 1.  FDA Draft Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

    Posted Dec 23, 2021 03:20:00 AM
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    Hi All,

    The FDA just published for Comment: FDA Draft Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

    This guidance outlines recommendations intended to facilitate the use of DHTs in a clinical investigation as appropriate for the evaluation of medical products. These recommendations address some of the information that should be contained in an investigational new drug application (IND) or an investigational device exemption (IDE) application for a clinical investigation in which the sponsor plans to use one or more DHTs or in a marketing application that includes such a clinical investigation.

    Submit comments online at https://www.regulations.gov/docket/2021-D-1128

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    Michael Roza CPA, CISA, CIA, MBA, Exec MBA
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