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U.S. Department of Health and Human Services

Medical Devices

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Sample Account Letter Sent to FURLS Users (October 1, 2007)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service
Food and Drug Administration
9200 Corporate Blvd. HFZ-308
Rockville, Maryland 20850-4015
 

TO: JOHN SAMPLE
DEVICE ESTABLISHMENT
123 N MAIN ST.
YOURTOWN OK 59999
 

RE: DEVICE ESTABLISHMENT
742 EVERGREEN TERRACE
SPRINGFIELD US 66666
REGISTRATION NUMBER: 1111111
OWNER/OPERATOR NUMBER: 9999999


Dear JOHN SAMPLE:
 

On October 1, 2007, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) will launch a web-based medical device registration and listing system that will allow you to submit your registration and listing to CDRH electronically. This new system, which will be part of the FDA Unified Registration and Listing System (FURLS), will replace forms FDA 2891, Registration of Device Establishment; FDA 2891a, Annual Registration of Device Establishment; and FDA 2892, Device Listing.


Beginning on October 1, 2007, all medical device establishment registration and device listing information must be submitted to CDRH through the FURLS Device Registration and Listing Module (DRLM).
 

To access FURLS DRLM, point your browser to the device registration and listing homepage at www.fda.gov/cdrh/reglistpage.html. Important information regarding changes to the registration and listing program and the use of the new system will be posted on that page. Beginning October 1, a link will be added to that page that will take you to FURLS DRLM.
 

As the official correspondent for the establishment shown above, you have already been assigned a FURLS Account ID, Password and Account Type to access the new system. You will need to enter your Account ID and Password to access your registration and listing data or to make changes to your FURLS account. The Account ID, Password and Account Type assigned to you for this establishment are:
 

Account ID: des12345 Password: xxxxxxxx Account Type: OWNER OPERATOR
 

Owner Operator Account Data Sent To: JOHN SAMPLE
 

If you have not previously provided your email address as part of your device establishment registration, you must update your FURLS account with this information before you can update your registrations and listings. If your account type is Owner Operator, you can do this when you first access FURLS after entering your Account ID and Password. If your account type is Official Correspondent, you must contact your owner operator to have your email address added to your account.
 

Once you have logged into FURLS, you will need to click the button labeled Device Registration and Listing Module. Upon entering DRLM, you must first complete the 2008 annual registration for your establishment(s). The web-based system will prompt you through this process.
 

To complete your 2008 annual registration, you will need the following information in addition to your Account ID and Password:

  • The Premarket Approval (PMA), Product Development Protocol, 510(k), Humanitarian Device Exemption, New Drug Application numbers assigned to each of your non-exempt medical devices
  • Any changes to your establishment, owner/operator, official correspondent or US agent (foreign establishments only) information
  • Any changes, additions or deletions to your list of products

An important change to medical device establishment registration is that certain types of establishment are now required by the MDUFMA II amendments to pay an annual establishment registration fee. They are:

  • Device manufacturers,
  • Contract sterilizers (establishments that sterilize a device for a specification developer or any other person)
  • Contract manufacturers (establishments that make a device for a specification developer or any other person)
  • Single-use device reprocessors
  • Specification developers

Please review the information sheet enclosed with this letter prior to logging into the new system. It contains further information about how to use the electronic system and changes to the device establishment registration and device listing program.
 

We look forward to working with you to make the transition to electronic reporting of registration and listing information as smooth as possible. If you have any questions, please first visit our website. If you need more information, please send an email to device.reg@fda.hhs.gov or call 240-276-0111.