Medical Devices
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Guidance Documents (Medical Devices and Radiation-Emitting Products)
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About Guidance
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Additional Information
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)
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Contact FDA
1-800-638-2041
301-796-7100
Fax:301-847-8149
CDRH-Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
Office of Communication, Education and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
WO66-4621
Silver Spring, MD 20993
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