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 · 2026/5/291 分で読めます
Content of Human Factors Information in Medical Device Marketing Submissions; 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 a final guidance titled "Content of Human Factors Information in Medical Device Marketing Submissions." This guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be included in a marketing submission to the Center for Devices and Radiological Health (CDRH) to facilitate the efficiency of the FDA review process.
情報源の原言語: Federal Register — Health and Human Services原文の発表を開く →