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)
- Draft Guidance - eCopy Program for Medical Device Submissions (PDF - 605KB)
- Guidance - FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
- Guidance - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals