Donawa Maria
Dona Consulting, Rome, Italy.
Med Device Technol. 2007 Oct;18(6):24-7.
Medical device manufacturers conducting clinical studies outside the United States (US) to support US regulatory submissions should be prepared to show that these studies are conducted in a manner that will be acceptable to the Food and Drug Administration. This article discusses the audits that can be conducted to assess this acceptability.
在美国境外开展临床研究以支持美国监管申报的医疗器械制造商应做好准备，证明这些研究的开展方式将为美国食品药品监督管理局所接受。本文讨论了为评估这种可接受性而可进行的审核。
