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  • Title: FDA pilot programme in support of global harmonisation.
    Author: Donawa ME.
    Journal: Med Device Technol; 2003 Nov; 14(9):32-4. PubMed ID: 14682021.
    Abstract:
    Imagine having one document that would demostrate the conformity of a medical device with regualtory requirements worldwide. Although it may be some time before this goal is reached, the United States Food and Drug Administration is launching a premarket review pilot programme in support of global harmonisation. This article discusses the programme and why European manufacturers should consider participating.
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