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Implementing the Medical Device Amendments: The Case of Serum Vitamin B12 Kits

Published online by Cambridge University Press:  01 January 2021

Thomas Necheles
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Within the past decade, in vitro diagnostic kits have become increasingly important to the clinical laboratory. Smaller hospital laboratories, in particular, lack the resources to develop and evaluate the large number of laboratory tests considered standard today. For these laboratories, the commercially available reagents, packaged with directions for use, provide a simple method of adding an otherwise unavailable test to the laboratory “menu.” These laboratories, however, are precisely the ones which lack the time, resources, and personnel to evaluate each kit. Furthermore, many manufacturers provide little or no information to back up their labeling claims for in vitro diagnostic kits, and there is little independently published information on the subject. The laboratory director is left to rely upon the integrity of the manufacturer, and typically chooses between competing products on the basis of unit cost and ease of performance.

Congress addressed these problems with the Medical Device Amendments of 1976, which extended the application of the Food, Drug and Cosmetic Act.

Type
Article
Information
Medicolegal News , Volume 9 , Issue 3 , June 1981 , pp. 10 - 14
Copyright
Copyright © American Society of Law, Medicine and Ethics 1981

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