US Medical Devices: Choices and Consequences

52 Pages Posted: 22 Apr 2021

See all articles by Richard A. Williams

Richard A. Williams

George Mason University - Mercatus Center

Robert F. Graboyes

Independent

Adam D. Thierer

Independent

Date Written: October 2015

Abstract

The FDA’s system for regulating medical devices has been criticized for retarding innovation because it adds uncertainty and costs to the invention process and delays the approval of devices. Because this system was created 40 years ago, it does not reflect societal changes in information technology, our understanding of safety, and international trade. Recent attempts to improve it by taking patient preferences into account are misguided because patient preferences are individualized: what is needed is a system that caters to individual risk-benefit preferences. We conclude that a new system of medical device approvals is needed—one that grants approval authority to multiple private bodies, allowing them to compete with the FDA and each other on the price, quality, and timeliness of approvals. Such a system would cater to healthcare entities’ and patients’ individual risk-benefit preferences. It would also spur innovation at a much greater rate than does the current institutional arrangement.

Keywords: medical devices, regulation, Food and Drug Administration, innovation, patient preferences

JEL Classification: I1, H51

Suggested Citation

Williams, Richard A and Graboyes, Robert F. and Thierer, Adam D., US Medical Devices: Choices and Consequences (October 2015). Mercatus Research Paper Series, Available at SSRN: https://ssrn.com/abstract=3831554 or http://dx.doi.org/10.2139/ssrn.3831554

Richard A Williams (Contact Author)

George Mason University - Mercatus Center ( email )

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United States
703 993 4515 (Phone)

Robert F. Graboyes

Independent ( email )

Adam D. Thierer

Independent ( email )

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