この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2004/5/141 分で読めます
Guidance for Industry and Food and Drug Administration Staff; Premarket Assessment of Pediatric Medical Devices; Availability
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Premarket Assessment of Pediatric Medical Devices." This guidance presents FDA's current thinking on the type of safety and effectiveness information needed to support marketing of pediatric devices and on measures to be used to help protect this vulnerable patient population during the course of clinical trials involving such products.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →