Abstract
The changes introduced by the Medical Device User Fee and Modernisation Act should ensure a timely and effective review process. The impact of some of the reforms is discussed here.
MeSH terms
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Biotechnology / instrumentation
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Biotechnology / legislation & jurisprudence
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Consumer Product Safety / legislation & jurisprudence
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Device Approval / legislation & jurisprudence*
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Drug Approval / legislation & jurisprudence
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Drug Industry / legislation & jurisprudence
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Equipment and Supplies
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Health Care Reform / legislation & jurisprudence*
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Health Care Reform / trends
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Legislation, Drug*
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Product Labeling / legislation & jurisprudence
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Product Surveillance, Postmarketing / methods
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Product Surveillance, Postmarketing / standards
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Public Policy
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United States
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United States Food and Drug Administration / organization & administration*
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United States Food and Drug Administration / trends*