Introduction

The world of medical devices encompasses a wide variety of products from single use disposable to short- or long-term implantable to multiple use durable capital equipment, from products that are used to monitor to those used to diagnose or treat, and from products that deliver their effect through electronic means to those who do so via mechanical or chemical means. In addition, all these products involve both the user and patient (at times the same) and are used in a variety of settings (e.g. from hospital to home care).

The Center for Devices and Radiological Health (CDRH) is that part of the US Food and Drug Administration (FDA) that helps ensure that the world of medical devices (see addendum for definition) intended for human use is safe and effective and helps reduce unnecessary exposure to radiation from medical, occupational, and consumer products. The industry that the FDA regulates accounted for $129.5 billion in global business in 1996 and consisted of 3000 product lines and 84 000 individual products (Wilkerson Group, 1995; Gallivan, 1997). Furthermore, the US industry in 1997 was comprised of approximately 6000 medical and diagnostics companies, about 80% of whom employed 50 or fewer people. These small entrepreneurial entities accounted for only 10% of sales, whereas the largest 2% accounted for 45% of sales (Lewin Group, Inc., 2000).

The agency's mandate is carried out through both premarket product evaluation and postmarket oversight that continues over the lifetime of the

* The opinions or assertions presented herein are the private views of the authors and are not to be construed as conveying either an official endorsement or criticism by the US Department of Health and Human Services, the Public Health Service, or the US Food and Drug Administration.

This material fits the description in the US Copyright Act of a "United States Government Work'', i.e. all authors are bona fide officers or employees of the US Government, and that the work was prepared as a part of these authors' official duties as a government employee, and therefore is not subject to US copyright. The chapter is now freely available for publication, without a copyright notice, and there are no restrictions on its use, now or subsequently, for non-commercial government purposes.

product, from early design to widespread use, and ultimately, to obsolescence. At major junctures of a product's life cycle, the FDA must weigh the product's benefits and risks. Central to this risk management function is the FDA's decision for marketing, one that must ensure that beneficial medical products are available (and labeled with adequate information on their benefits and risks) while protecting the public from unsafe products or false claims (Food and Drug Administration, 1999a). Once marketed, a product's continued safety and effectiveness must be ensured not only by oversight on the part of industry and the FDA, but most importantly by healthcare providers' and patients' appropriate product selection and use based on the product's labeling.

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