Abstract
The U.S. Food and Drug Administration (FDA) regulates $960 billion worth of products, which accounts for approximately 25 cents of every dollar spent annually by American consumers. The regulatory environment is quite different from the contractual environment where the use of particular standards is dictated. In contrast the regulated industries, which in FDA's case includes the manufacturers of food, cosmetics, pharmaceuticals, and medical devices, are responsible for selecting and justifying the selection and use of appropriate national and/or international consensus standards. The challenge faced by the regulated industries is how to evaluate and select appropriate standards, in particular safety and reliability standards.
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