目前FDA CDRH 提供的相關教育訓練課程影片與簡報：
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課程名稱
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影片
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簡報檔
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FDA醫療器材法規簡介 (An Introduction to FDA’s Regulation of Medical Devices)
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Video
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pdf
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品質系統法規簡介 (Overview of the Quality System Regulation)
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Video
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pdf
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公司註冊與產品列名 (Device Establishment Registration and Listing)
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Video
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pdf
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510(k) 程序 (The 510(k) Program)
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Video
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pdf
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格式導引，包含標準表格, 增列與臨床試驗表格及510(k)
[Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)]
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Video
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pdf
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510(k) 審查費 (510(k) User Fees)
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Video
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pdf
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510(k) 第三方審核 (510(k) Third Party Review Program: Overview)
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Video
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pdf
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513(g)介紹，包含513(g)申請費 ("513(g)s" Including 513(g) User Fees)
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Video
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pdf
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醫療器材不良事故電子通報
[Electronic Medical Device Reporting (eMDR)]
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Video
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pdf
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醫療器材不良事故通報 (Overview of Medical Device Reporting)
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Video
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pdf
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給強制性通報者的不良事故通報 (Medical Device Reporting for Mandatory Reporters)
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Video
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pdf
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給製造商的不良事故通報指南 (Final Guidance on Medical Device Reporting for Manufacturers)
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Video
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pdf
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