The Regulation of Wearable Medical Devices

Nan Jiang; Julia E Mück; Ali K Yetisen

doi:10.1016/j.tibtech.2019.06.004

The Regulation of Wearable Medical Devices

Trends Biotechnol. 2020 Feb;38(2):129-133. doi: 10.1016/j.tibtech.2019.06.004. Epub 2019 Jul 15.

Authors

Nan Jiang¹, Julia E Mück², Ali K Yetisen³

Affiliations

¹ School of Engineering and Applied Sciences, Harvard University, Cambridge, MA 02138, USA.
² Department of Chemical Engineering, Imperial College London, London SW7 2AZ, UK.
³ Department of Chemical Engineering, Imperial College London, London SW7 2AZ, UK. Electronic address: a.yetisen@imperial.ac.uk.

PMID: 31320119
DOI: 10.1016/j.tibtech.2019.06.004

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.

Keywords: commercialization; manufacturing; medical devices; regulations; wearables.

MeSH terms

Device Approval / legislation & jurisprudence*
Equipment Design
Humans
United States
United States Food and Drug Administration / legislation & jurisprudence
Wearable Electronic Devices*