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30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff

30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: 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:2019-12-16。官方主题:Premarket, Administrative / Procedural, Device & Drug Safety, HUD/HDE, Premarket Approval (PMA)。请通过官方原文与附件查阅文件。

来源:FDA Guidance Documents · fda.gov