Of the issues of greatest significance to the IVD industry, few have received more attention in recent years than labeling. Both within the United States and abroad, a proliferation of regulatory requirements involving labeling has challenged IVD companies to look for ways to reduce or harmonize requirements in the various countries where they do business. This article, developed by the IVD labeling working group of the Health Industry Manufacturers Association (HIMA) and the labeling committee of the Association of Medical Diagnostics Manufacturers (AMDM), focuses on just a few of these issues and provides recommendations for regulators worldwide. For the past several years, "Truth in Labeling" has been a byword of FDA's Division of Clinical Laboratory Devices when discussing IVDs. There is no disagreement between FDA and regulated industry with respect to the need to provide accurate, informative, and straightforward labeling to users of IVD products and others affected by those products. However, there are differences of opinion, both within and between industry and FDA, with respect to what information is most useful and the best means of conveying that information. Although U.S. laws and regulations pertaining to IVD labeling have not changed significantly during the past 20 or more years, the world in which these products are sold has changed significantly. It is important to look at the background of the current labeling regulations, along with FDA's intent for labeling. It is also important to recognize the spread of product marketing globally, the needs of users and other customers today, and the alternative means that are available today for industry, FDA, and customers for addressing IVD labeling needs worldwide. Although FDA has published a draft guidance recommending that medical device labeling include certain information in a specified format, the agency's regulatory requirements for the labeling of most medical devices are very
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Topics of Interest
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