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  3. The Future of Medical Device Regulation
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    • Open access
  • Cited by 3
Publisher:
Cambridge University Press
Online publication date:
March 2022
Print publication year:
2022
Online ISBN:
9781108975452
DOI:
https://doi.org/10.1017/9781108975452
Creative Commons:
Creative Common License - CC Creative Common License - BY Creative Common License - NC Creative Common License - ND
This content is Open Access and distributed under the terms of the Creative Commons Attribution licence CC-BY-NC-ND 4.0 https://creativecommons.org/creativelicenses
Subjects:
Medico-Legal, Bioethics and Health Law, Law, Medicine, Medical Law, Ethics and forensic Medicine
Information

Book description

Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.

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