The Future of Medical Device Regulation: Innovation and Protection

The regulatory approach to medical devices has been more permissive than drugs and biologics, leading to public health and safety concerns. The nature of medical devices is rapidly changing, with software becoming as important as hardware. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU, offering a framework for opportunities and challenges in regulation.

Format: Paperback / softback
Length: 350 pages
Publication date: 07 April 2022
Publisher: Cambridge University Press

Regulators have shown a more lenient approach towards medical devices compared to their drug and biologic counterparts. While this approach enables innovative products to reach consumers more swiftly, it raises significant public health and safety concerns. Moreover, the nature of medical devices is evolving rapidly, with software playing an increasingly crucial role alongside hardware. Consequently, regulation must adapt to keep pace with the evolving developments and controversies surrounding this technology.

This comprehensive volume offers a multidisciplinary examination of the ethical, legal, and regulatory issues surrounding medical devices in the United States and the European Union. It serves as a valuable resource for medical providers, policymakers, and other stakeholders seeking to navigate the opportunities and challenges on the horizon of medical device regulation. Readers will gain a nuanced understanding of the latest advancements in patient privacy and safety, innovation, and new regulatory laws.

Additionally, this book is available as Open Access on Cambridge Core, ensuring widespread access to its insights and knowledge.

ISBN-13: 9781108972055
Edition number: New ed