Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

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href="/media/155022/download">Download the Final Guidance Document</a> <a class="btn btn-primary" href="https://www.federalregister.gov/documents/2023/12/22/2023-28262/digital-health-technologies-for-remote-data-acquisition-in-clinical-investigations-guidance-for">Read the Federal Register Notice</a> </div> <div class="lcds-statusbar text-center"> <span class="label label-default">Final</span> <span class="label label-default">Level 1 Guidance</span> </div> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fdigital-health-technologies-remote-data-acquisition-clinical-investigations" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a 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Number:</dt> <dd class="cell-2_1"><a href="https://www.regulations.gov/docket/FDA-2021-D-1128">FDA-2021-D-1128</a></dd> <dt class="cell-1_2">Issued by:</dt> <dd class="cell-2_2"><a href="/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations"></a> <div class="field field--name-field-issuing-office-taxonomy field--type-entity-reference field--label-above"> <div class="field--label">Guidance Issuing Office</div> <div class="field--items"> <div class="field--item">Oncology Center of Excellence</div> <div class="field--item">Center for Biologics Evaluation and Research</div> <div class="field--item">Center for Devices and Radiological Health</div> <div class="field--item">Center for Drug Evaluation and Research</div> </div> </div> </dd> </dl> </div> <p>This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products.  DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions.  Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient.</p> <div class="callout"> <h2>Additional Guidance Resources: </h2> <ul> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="af1fd998-5180-4705-b2b6-58062ce4d88c" href="/media/180193/download?attachment" title="Guidance Snapshot: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations">DHT for Remote Data Acquisition in Clinical Investigations: Guidance Snapshot</a> </li> <li><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="1bcf2558-c6b1-4749-a0ab-3f97415e13ed" href="/media/180060/download?attachment" title="Podcast for DHT Final">DHT for Remote Data Acquisition in Clinical Investigations: Guidance Recap Podcast</a> </li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0866c02a-ecca-415f-a707-1fa2f4477679" href="/drugs/guidances-drugs/guidance-recap-podcast-digital-health-technologies-remote-data-acquisition-clinical-investigations" title="Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations">DHT for Remote Data Acquisition in Clinical Investigations: Guidance Recap Podcast Transcript</a></li> </ul> </div> <div class="inset-column"> <hr> <h2>Submit Comments</h2> <div class="row"> <div class="col-xs-12 col-sm-4"> <a class="btn btn-primary" <a href="https://www.regulations.gov/docket/FDA-2021-D-1128/document">Submit Comments Online</a> </div> <div class="col-xs-12 col-sm-8"> <p class="lcds-explainer-txt">You can submit online or written comments on any 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