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 · 2010/1/201 分で読めます
Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications; 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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications." This draft guidance document describes FDA's recommendations about investigational device exemption and premarket approval applications for heart valves. This draft guidance document is not final, nor is it in effect at this time.
情報源の原言語: Federal Register — Health and Human Services原文の発表を開く →