The Future of Medical Device Regulation: Innovation and Protection
This edited volume is based on the Petrie-Flom Center’s 2020 annual conference, which brought together leading experts to explore the challenges medical device regulation might face globally, including the correct balance between patient protection and avoiding stifling business and innovation, the changing nature of medical devices to become increasingly software-based, and the difficulties of post-market surveillance.
This year’s conference is organized in collaboration with Timo Minssen, University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL); Nicholson Price, University of Michigan School of Law; and Christopher Robertson, James E. Rogers College of Law of the University of Arizona. This year’s conference is organized in collaboration with the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL) and the University of Arizona Health Law Program.
From the Publisher:
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.