WEARABLE HEALTHCARE TECHNOLOGY – THE REGULATORY PERSPECTIVE
Abstract
The world today isn’t the one which it was yesterday. With the continuing evolution in technology and technological
applications on medical field, innovative products and services have been emerging every day. Wearable gadgets
have risen up as revolution in the medical field for patient care. A number of tech giants are pouring into this
segment; wearables have already shown an impact on various fields such as communication and navigation; but
perhaps the greatest potential lies in healthcare. With this article, an attempt has been made to unlock the potential of
wearable healthcare technology and the regulatory aspects imparted on them currently.
Downloads
References
and Healthcare’ [Internet]. United States: Hopkins
Biotech Network; 2014 Dec. [cited 2015 Nov 2].
Available from:
http://hopkinsbio.org/biotechnology/regulatorystandpoint-wearables-healthcare/
2. MDDI Magazine [Internet]. United States: Medical
Device and Diagnostic Industry Magazine; 2014 June
[cited 2015 Oct 27]. Available from:
http://www.mddionline.com/article/wearable-techregulated-medical-devices-can-revolutionizehealthcare-6-18-2014
3. Barbera L. ‘Wearable Technology Regulations: What
Product Designers Need to Know’ Kaleidoscope
[Internet]. Industry Insights; 2015 Feb [cited 2015
Nov 3]. Available from:
http://kascope.com/wearable-technology-regulationswhat-product-designers-need-to-know/
4. US Food & Drug Administration [Internet]. United
States: FDA Guidance Document 1741 – Mobile
Medical Applications: Guidance for Industry and
Food and Drug Administration Staff; 2015 April
[cited 2015 Oct 25]. Available from:
http://www.fda.gov/downloads/medicaldevices/device
regulationandguidance/guidancedocuments/ucm44313
3.pdf
5. US Food & Drug Administration [Internet]. United
States: FDA Draft Guidance Document – General
Wellness: Policy for Low Risk Devices; Draft
Guidance for Industry and Food and Drug
Administration Staff; 2015 Jan [cited 2015 Oct 25].
Available from:
http://www.fda.gov/downloads/medicaldevices/device
regulationandguidance/guidancedocuments/ucm42967
4.pdf
6. Saxena V. ‘FDA to avoid regulating most wearables,
seeking to reduce device accessory regulation overall’
[Internet]. Fierce Medical Devices; 2015 Jan [cited
2015 Nov 3]. Available from:
http://www.fiercemedicaldevices.com/story/fdaavoid-regulating-most-wearables-seeking-reducemedical-device-regulatio/2015-01-20
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
