The Future of Medical Device Regulation: Innovation and Protection

Title

The Future of Medical Device Regulation: Innovation and Protection

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Editor(s)

I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, Carmel Shachar

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.

ISBN

9781108838634

Publication Date

2022

Publisher

Cambridge University Press

City

New York

Keywords

medical instruments and apparatus, medical law, medical legislation

Disciplines

Law | Medical Jurisprudence | Medicine and Health Sciences

The Future of Medical Device Regulation: Innovation and Protection

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