Regulating Medical Devices: The Values and Politics of the US FDA Review Process.

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