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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