Medical Device Labeling: The Importance of Sharing Your Perspective

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Abstract

The US Food and Drug Administration’s (FDA’s) mission, through its Center for Devices and Radiological Health, is to protect and promote public health. One part of protecting patients when reviewing new medical devices is to ensure that the associated device labeling can be effectively used by the device operator—or can effectively complement training on the use of the device. This article outlines some examples of how clinical engineers and clinicians can work together to help device manufacturers and the FDA ensure that device labeling effectively communicates key information about the medical device and shares some examples of reports that the FDA has received related to problems with device labeling.

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