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Medical devices have historically been less regulated than their drug and biologic counterparts. A benefit of this less demanding regulatory regime is facilitating innovation by making new devices available to consumers in a timely fashion. Nevertheless, there is increasing concern that this approach raises serious public health and safety concerns. The Institute of Medicine in 2011 published a critique of the American pathway allowing moderate-risk devices to be brought to the market through the less-rigorous 501(k) pathway,1 flagging a need for increased postmarket review and surveillance. High-profile recalls of medical devices, such as vaginal mesh products, along with reports globally of nearly two million injuries and more than 80,000 deaths linked to faulty medical devices,2 have raised public health critiques regarding the oversight of these products. Should we follow the recommendation of the Institute of Medicine to reduce the use of the 510(k) pathway, and, if so, what should replace it? What would an ideal regulatory pathway, reflecting the twin goals of innovation and patient protection, look like in the twenty-first century? These questions are complicated by new tools and mechanisms that can be used to achieve our goals. For example, in an era of big data, where we have the capabilities to better follow postmarket incidents, what should postmarket review look like?
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.
Part IV, Consumer Genetics and Identity, focuses on the personal impact that consumer genetic technologies can have. The reader is asked to consider how genetic information forces individuals to reevaluate their family histories and patients to consider their medical futures. At the same time, Part IV also reminds the reader that identity goes beyond an individual, that we are defined by other characteristics such as race. Each chapter also considers the role that genetic testing can play in supporting or undermining self-determination.
For the average person genetic testing has two very different faces: the rise of genetic testing is promoted as the democratization of genetics by enabling individuals to gain new insights into their unique makeup. At the same time, many regard genetic testing and sequencing as revealing something intensely personal and private about themselves. Genetic testing raises legal and ethical questions that loom ever larger, especially as genetic testing is becoming more commonplace, affordable, and comprehensive. Already in 2018 the global genetic testing and consumer/wellness genomics market was valued at $3.4 billion, with market analysts in 2019 predicting that it will double in value by 2025.