A US FDA medical device update, Part II.
This column in last month's edition discussed answers to some of the questions raised at a recent Food and Drug Administration (FDA) conference held in Paris. This article continues that discussion and includes questions and answers concerning harmonization and good manufacturing practice (GMP) requirements. As in the preceding column, the answers were provided by FDA speakers at the conference or subsequently confirmed in discussions with the author.
Donawa
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Donawa and Associates Ltd., Rome, Italy.
D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards* / Q000600:supply & distribution; D017408:Guidelines as Topic; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration