Volume Introduction

Authors

I. Glenn Cohen, Harvard Law SchoolFollow
Timo Minssen, University of CopenhagenFollow
W. Nicholson Price II, University of Michigan Law SchoolFollow
Christopher Robertson, Boston UniversityFollow
Carmel Shachar, Harvard Law SchoolFollow

Document Type

Introduction

Publication Date

2022

Abstract

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?

Comments

Open access, Limit to one chapter of a monograph. For monographs with multiple authors, each contributor may archive their own single chapter. See Table for Green OA for Books. For journal articles (publisher's version), permissions needed

Recommended Citation

Cohen, Glenn, Timo Minssen, W. Nicholson Price II, Christopher Robertson, and Carmel Shachar. "Volume Introduction." Introduction to The Future of Medical Device Regulation: Innovation and Protection, edited by Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, and Carmel Shachar, 1-10. . Cambridge: Cambridge University Press, 2022.