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 · 2009/4/171 分で読めます
Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemption Guidance for Retinal Prostheses; Availability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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Investigational Device Exemption (IDE) Guidance for Retinal Prostheses." This draft guidance document provides recommendations to industry about developing pre- clinical and clinical tests of retinal prosthetic devices for submission to FDA in an IDE application. This draft guidance is not final nor is it in effect at this time.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →