US regulatory hurdles: towards international harmonization
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1Regulatory Affairs and Quality Assurance, Diagnostic Division, Ares-Serono Inc, Boston, Massachusetts.
Biosensors & Bioelectronics
|January 1, 1992
Abstract:
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.