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Short abstract:

In this paper, we identify the values that animate the United States Food & Drug Administration (USFDA)’s review of medical devices. Using an AI approved radiology algorithm as a case study, we examine the values and politics that shape regulation of medical technologies in the United States.

Long abstract:

Much of the STS scholarship and popular discourse on national regulation of pharmaceuticals and medical devices has focused on drugs. There has been little attention to how regulatory agencies review and regulate medical devices. However, since the mid 20th century, medical devices are increasingly used in routine clinical care. Medical technologies include a broad range of objects such as MRI and other imaging machines, genomic assays, surgical implants, assistive devices, and most recently algorithms. Given the rise of biomedical engineering and computer science and these fields’ investment in finding new healthcare markets, the proliferation and regulation of medical devices is important to attend to. In this paper, we identify the values that animate the United States Food & Drug Administration (USFDA)’s review of medical devices. Unlike pharmaceuticals that undergo clinical trials, medical devices are reviewed through multiple pathways that vary in their standards for approval, ranging from required in-human clinical trials, to other pathways which enable devices to make it to market without such safety and efficacy studies. As artificial intelligence (AI) tools become commonplace in a variety of settings including biomedical research and healthcare delivery, one particularly important field they have infiltrated is radiology. Radiology has the greatest number of FDA-cleared AI applications compared to other medical specialties. Using an AI approved radiology algorithm as a case study, we examine the values and politics that shape regulation of medical technologies in the United States. Our paper contributes to STS scholarship on medical devices, regulation, AI, and evidence-based medicine.