, Volume 23, Issue 1 Supplement, p 1,
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Date: 19 Dec 2007

Introduction

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New medical device technologies have the potential to revolutionize health care delivery in the United States. With device technologies as diverse as the artificial lumbar disc, fecal DNA testing, cardiac resynchronization therapy, and coronary artery calcium measurements, the promise of new medical devices is great, but the risks of misuse and overuse are substantial. In spite of the ubiquity and impact of medical technology, many physicians do not understand the process by which these technologies appear in the marketplace and how this differs from that for new pharmaceuticals. Indeed, the level of evidence required for FDA approval of new devices is, in most cases, far less stringent than for pharmaceuticals. Most generalists do not know where to turn for evidence-based information when a patient asks about the latest device advertised in the local newspaper or when a specialist recommends a high-tech solution to a common problem.

The impetus for this JGIM supplement grew out of a sp ...