FDA Guidance Documents·· 原文未提供具体时分
Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff
Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff
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FDA 官方历史目录记录；Final guidance；发布日期：2004-06-02。官方主题：User Fees, 510(k)。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov