The Regulation of Wearable Medical Devices

descriptionPublicationkeyboard_double_arrow_right Article 01 Feb 2020 English Publisher:Elsevier BVJournal:Trends in Biotechnology, volume 38, pages 129-133 (issn: 0167-7799,

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Authors: Nan, Jiang; Julia E, Mück; Ali K, Yetisen;

doi: 10.1016/j.tibtech.2019.06.004

pmid: 31320119

The Regulation of Wearable Medical Devices

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Abstract

This article provides a guideline for the design, manufacture, regulatory approval, and post-market surveillance (PMS) of wearable medical devices (WMDs). The integration of regulatory considerations can accelerate wearable device (WD) development from laboratory to market while mitigating device failure risks. The implementation of stringent clinical evaluations will transcend WDs beyond consumer products.

Related Organizations

Harvard University
United States
Imperial College London
United Kingdom

Keywords

Wearable Electronic Devices, United States Food and Drug Administration, Device Approval, Humans, Equipment Design, United States

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