Regulating Biomedical Innovation: The Values and Politics of the US FDA Medical Device Review Process

• In Event: 20451 - Exciting New Medical Sociology that Everyone Should Know About

Abstract

Since the mid 20th century, medical and health technologies have proliferated in a variety of settings, from outpatient clinical care to surgical theaters, and in everyday life via home health and wearable technologies. Medical devices include a broad range of technologies such as imaging technologies, genomic assays, surgical implants, assistive devices, health monitors, and most recently artificial intelligence/machine learning (AI/ML) enabled devices. Unlike pharmaceuticals, food and cosmetics, the United States Food and Drug Administration (US FDA) did not initially focus on regulating medical devices in the early 1900s; devices only became a site of concern post-World War II as more complex, invasive technologies were developed and embedded in patient care. In the sociological literature, too, medical device regulation has received little attention, with scholars more often attending to the development and regulation of pharmaceuticals. Drawing on analysis of FDA regulations, government documents, historical media coverage, and oral histories of FDA staff involved in establishing medical device regulation, this article traces the evolution of medical device regulation over the past fifty years, historicizing persistent debates that position medical technology innovation and regulation at odds with one another. We show how a lack of legal authority limited the FDA’s ability to regulate medical devices, positioning them as reactive to the proliferation of medical technologies in the late 20th century. We then analyze the construction of risk classifications and regulatory pathways used to review medical devices and the values embedded in them and consider the consequences for the public’s safety and trust.

Authors

• Melanie Jeske, Baylor College of Medicine

• Kelly A. Joyce, University of North Carolina, Greensboro