FDA Guidance Documents·· 原文未提供具体时分
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff
AI 导读
FDA 官方历史目录记录；Final guidance；发布日期：2025-08-18。官方主题：Premarket, Digital Health。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov