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 · 2025/6/51 分で読めます
Transfer of a Premarket Notification (510(k)) Clearance-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Transfer of a Premarket Notification (510(k)) Clearance--Questions and Answers." This guidance provides information on the most frequently asked questions regarding transfer of ownership from one 510(k) holder to another. This draft guidance is not final nor is it for implementation at this time.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →