Guidance Documents (Medical Devices and Radiation-Emitting Products)
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Blue Book Memos - ODE Guidance Memoranda Recent Medical Device Guidance Documents Most Popular Medical Device Guidance Documents Standard Operating Procedure for "Notice to Industry" Letters(PDF - 66KB) Federal Register Notice: Standard Operating Procedure for Notice to Industry Letters CDRH Guidance Development SOP(PDF - 165KB)
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations (PDF)(PDF - 564KB)