Medical Devices
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Documents
Due to changes to regulatory requirements, the 2009 guidance document titled "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and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007" was withdrawn on May 13, 2013. The Center for Devices and Radiological Health is currently working on a new medical device establishment registration and device listing draft guidance that, when finalized, will represent the FDA’s current thinking on this topic.
Please see related links below for important Registration and Listing information.
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Information Bulletins
FDA Device Establishment Registration and Listing Newsletter - June 2012 FDA Device Establishment Registration and Listing Newsletter - September 2010 FDA Device Establishment Registration and Listing Update - September 2009 FDA Device Establishment Registration and Listing Update - August 2009 FDA Device Establishment Registration and Listing Update - July 2009 FDA Device Establishment Registration and Listing Update - June 2009 FDA Device Establishment Registration and Listing Update - May 2009 FDA Device Establishment Registration and Listing Update - April 2009 FDA Device Establishment Registration and Listing Update - March 2009
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Letters
To: Firms Without an Assigned Establishment Registration Number - Steps to Complete Annual Registration and Listing for FY2010 (10/09) Communication to Firms Regarding Annual Registration for FY2009 (September 3, 2008) April 2008 Letter to Firms Who Did not Fulfill Their Annual Registration and Listing Requirements for Fiscal Year 2008 - Version 1 April 2008 Letter to Firms Who Did not Fulfill Their Annual Registration and Listing Requirements for Fiscal Year 2008 - Version 2 Postponement of 2008 Registration for All Registered Medical Device Establishments (June 19, 2007) Sample Account Letter Sent to FURLS Users (October 1, 2007) Insert to Sample Account Letter (October 1, 2007)
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