Abstract Since the mid-20th century, medical devices have proliferated in clinical care, operating rooms, and in everyday life via home health and wearable technologies. Medical devices include a broad range of technologies such as imaging devices, genomic assays, surgical implants, assistive devices, and health monitors. Unlike pharmaceuticals, food, and cosmetics, the United States Food and Drug Administration (FDA) did not prioritize medical device regulation in the early 1900s; devices only became a site of concern post-World War II as more complex and invasive technologies were developed and used in health care. Drawing on analysis of FDA regulations, government documents, historical media coverage, and FDA oral histories, this article traces the evolution of medical device regulation, historicizing persistent debates that position technological innovation and regulation in tension with one another. We demonstrate how limited legal authority prior to 1976 positioned FDA as lagging behind the proliferation of medical devices, which continues to haunt device regulation today. We then analyze the values embedded in device risk classifications and regulatory pathways, considering the consequences for the public’s safety and trust.
Jeske et al. (Fri,) studied this question.