Us Medical Devices: Choices and Consequences

52 Pages Posted: 7 Jun 2018

See all articles by Jonathan Camp

Jonathan Camp


Robert F. Graboyes

Mercatus Center at George Mason University

Date Written: 10/21/2015


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.

Suggested Citation

Camp, Jonathan and Graboyes, Robert F., Us Medical Devices: Choices and Consequences (10/21/2015). MERCATUS RESEARCH. Available at SSRN: or

Jonathan Camp


No Address Available

Robert F. Graboyes

Mercatus Center at George Mason University ( email )

3434 Washington Blvd. 4th Floor
Arlington, VA 22201
United States

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