The Future of Medical Device Regulation

Name: The Future of Medical Device Regulation
SKU: 35582292
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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.

Author Biography:

I. Glenn Cohen is James A. Attwood and Leslie Williams Professor of Law, Deputy Dean, and Faculty Director in the Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School. Timo Minssen is Professor of Law is Director of the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) in the Faculty of Law, University of Copenhagen, Denmark. W. Nicholson Price II is Professor of Law in the University of Michigan School of Law. Christopher Robertson is Professor and N. Neal Pike Scholar of Health and Disability Law in the School of Law, Boston University. Carmel Shachar is Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Release date Australia

April 7th, 2022

Audience

Postgraduate, Research & Scholarly

Contributors

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

Illustrations

Worked examples or Exercises

Pages

350

Dimensions

158x236x19

ISBN-13

9781108838634

Product ID

35582292

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