STAT December 3, 2021
Kushal Kadakia and Harlan M. Krumholz

Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex technologies like pacemakers and infusion pumps. Given the wide range of risks and benefits, Congress tasked the Food and Drug Administration in 1976 with determining whether new medical devices should be authorized for use based on their potential to help or harm patients.

Public health experts have long voiced concerns about this balancing act. In 2011, for example, the Institute of Medicine (IOM) issued a landmark report calling for reforms to improve the regulation of medical devices. While some of the recommendations have made their way into policy, others, like reform of the 510(k) pathway, have not. This pathway allows devices to be made...

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