federal_register: 2021-27894

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2021-27894 Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, investigators, and other stakeholders entitled "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations." This guidance provides recommendations to sponsors, investigators, and other stakeholders on the use of digital health technologies (DHTs) to acquire data remotely 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. 2021-12-23 2021 12 https://www.federalregister.gov/documents/2021/12/23/2021-27894/digital-health-technologies-for-remote-data-acquisition-in-clinical-investigations-draft-guidance https://www.govinfo.gov/content/pkg/FR-2021-12-23/pdf/2021-27894.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, investigators, and other stakeholders entitled "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations." This...

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