US regulatory hurdles: towards international harmonization.
What regulatory requirements must be met before a new medical device can be marketed in the USA? In this article, David Thomas reviews the regulations, examines the impact of recent legislation and looks at the emerging trend towards international harmonization of the regulation of health care products.
Thomas
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Regulatory Affairs and Quality Assurance, Diagnostic Division, Ares-Serono Inc, Boston, Massachusetts.
D015374:Biosensing Techniques; D004869:Equipment Safety; D004864:Equipment and Supplies; D007391:International Cooperation; D007878:Legislation as Topic; D014481:United States; D014486:United States Food and Drug Administration