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Registration and Listing

Reminders:

• FDA is aware that various firms may be offering their services to assist domestic and/or foreign facilities to register with FDA. Please note that these firms are not affiliated with FDA, nor has the agency contracted with any firms to register facilities. FDA does not use any outside contractors to notify or bill regulated industry about the need to register. FDA does not require firms to hire someone to complete the on-line registration process.
• All device establishments must complete their annual registration for Fiscal Year 2009 between October 1, 2008 and December 31, 2008.
• FDA instituted on October 1, 2008 a new payment process for establishments that are required to pay the device establishment user fee. If you are required to pay the establishment registration user fee (See Who Must Register, List & Pay the Fee), you must first visit the Device Facility User Fee website to pay the user fee. When logging onto the Device Facility User Fee website, please create a new user name and password. Your registration user name and password from last year are only to be used in the electronic Registration and Listing System (FURLS) Once you make payment and receive confirmation for your payment, you can proceed to the FURLS website, using your user name and password from last year to complete your registration and listing requirements. Do not create a new user name and password in FURLS. Contact us if you do not remember your user name and password from last year. Additional information can be found in these documents:
  
  • FAQ's for the Device Facility Establishment Registration User Fee (10/08)
  • Device Facility User Fee and Registration - a New Way of Processing (9/08)
  • How To Guide for the Device Facility User Fee Process (PDF format - 10/08)

Owners or operators of places of business (also called establishments or facilities) 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 reglist@cdrh.fda.gov.

Updated December 16, 2008