|Registration & Listing|
The electronic registration and listing system (FURLS) will be unavailable from noon on Friday, September 26th, 2008 until 5:00 PM EST on Wednesday, October 1st, 2008.
Device Facility Registration for FY 2009 cannot be done until October 1, 2008. Please read this document for details about the FY 2009 Registration period.
Owners or operators of places of business (establishments) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration. There is a fee for annual establishment registration for some establishment types.
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number (510(k), PMA, PDP, HDE).
The amendments to the Medical Device User Fee Modernization Act require that after September 30th, 2007, all registration and listing information be submitted electronically, unless a waiver has been granted.
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
Note: If you encounter an issue or wish to contact us regarding the Electronic Registration and Listing System (FURLS), please send an email to firstname.lastname@example.org.
Updated September 16, 2008
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