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Medical Devices

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Documents

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Information Bulletins

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Instructions

Instructions for Paying the FY 2009 Device Establishment Registration Fee and Completing the Annual Registration (10/08)
How To Guide for the Device Facility User Fee Process (10/08) (PDF - 1722KB)

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FAQs

FAQ's for the Device Facility Establishment Registration User Fee (10/08)
Frequently Asked Questions on Establishment Registration Fees and Electronic Registration and Listing for Medical Device Establishments

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Letters

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Federal Register

Registration & Listing Federal Register Documents

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Guidance Documents

Guidance for Industry and FDA Staff - Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007

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