Abstract
After expending considerable effort to comply with United States (US) marketing authorisation regulations, a company launched its first product on the US market. Unfortunately, the company failed to comply with other applicable US regulations, which led to a delay in the US product introduction and FDA postmarketing enforcement actions against the product. This article discusses ways that companies can prevent this from happening.
MeSH terms
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Commerce / legislation & jurisprudence*
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Commerce / standards
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Consumer Product Safety / legislation & jurisprudence
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Device Approval / legislation & jurisprudence*
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Device Approval / standards
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Equipment and Supplies / standards*
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Guidelines as Topic
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Product Labeling / legislation & jurisprudence*
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Product Labeling / standards
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Product Surveillance, Postmarketing / methods
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Product Surveillance, Postmarketing / standards*
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Radiation Protection / legislation & jurisprudence
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United States