Activity Number:
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362
- Health Policy Statistics Section P.M. Roundtable Discussion (Added Fee)
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Type:
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Roundtables
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Date/Time:
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Tuesday, August 1, 2017 : 12:30 PM to 1:50 PM
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Sponsor:
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Health Policy Statistics Section
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Abstract #324113
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Title:
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Wearable Devices in Daily Activities and Clinical Trials
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Author(s):
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R. Lakshmi Vishnuvajjala*
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Companies:
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FDA/CDRH
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Keywords:
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wearable devices ;
Regulation ;
Clincal trials ;
FDA
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Abstract:
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Wearable devices are expanding at a fast pace in many areas and are even being considered in clinical trials. It is not always easy to understand when they are regulated by FDA, and it is also changing constantly due to rapid changes in technology. How they are used and the generated data are interpreted can have a great impact on patient outcome and study results. Since they are also used in clinical trials and their use is increasing, this is an issue that needs to be understood clearly regarding advantages and problem areas.
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Authors who are presenting talks have a * after their name.
