A Balancing Act: Safety, Innovation, and Resources in the Implementation of Medical Device Legislation

Publication Title

Journal of Science Policy and Governance

Document Type

Article

Publication Date

2-2018

Abstract

The implementation of medical device legislation in the United States has been a complex undertaking colored by overlapping values. Policymakers have oscillated between favoring patient safety versus fostering innovation, while the limited resources available to the Food and Drug Administration (FDA) to implement policies often decide their true impact. The 510(k) process of premarket notification exemplifies this complexity. Originally a footnote in the legislation, the 510(k) process has risen to become the prominent form of premarket device regulation. With Congress using legislation first to reign in, then to loosen premarket notification, the 510(k) process has become the fulcrum on which patient safety and innovation are balanced. This article applies the Public Value Mapping framework to the implementation of medical device legislation in the United States to identify historical and ongoing tensions between values in the device policy space. Recent concerns over morcellation devices, which have been proven harmful to patients, threatens this status quo, and the struggle to balance safety, innovation, and the FDA's resources makes any significant changes to 510(k) likely to be slow.

Recommended Citation

Walter G. Johnson, A Balancing Act: Safety, Innovation, and Resources in the Implementation of Medical Device Legislation, J. Sci. Pol'y & Gov., Feb. 2018, at 1, https://www.sciencepolicyjournal.org/uploads/5/4/3/4/5434385/johnson_2018_jspg.pdf.

Volume

12

Issue

1

First Page

1

Last Page

19

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