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U.S. Department of Health and Human Services

Medical Devices

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Insert to Sample Account Letter (October 1, 2007)

CHANGES TO THE MEDICAL DEVICE ESTABLISHMENT REGISTRATION AND LISTING PROGRAM

Authority for Electronic Submission Of Registration And Listing Information

In October 2002, section 510 of the Federal Food, Drug, and Cosmetic Act (the Act) was amended by Section 207 of the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250) (MDUFMA I) to add a requirement for electronic submission of registration information. In September 2007, Congress enacted the Medical Device User Fee Amendments of 2007 (MDUFMA II) which further amended the device registration and listing provisions found in section 510 of the Act and also added provisions to sections 737 and 738 of the Act to require certain types of device establishments to pay user fees in connection with their initial or annual registration beginning on October 1, 2007. As amended, section 510(p) of the Act now requires all device establishments to submit their device registration and listing information by electronic means unless FDA grants their request for a waiver.

Instructions For Accessing The Electronic System

  • Point your browser to our web site . There will be a link on that page that will direct you the FDA Industry Systems page.
  • Using the Account ID and Password provided in the letter you received with these instructions, log in to the FDA Unified Registration and Listing System (FURLS).
  • On the next page, click the button labeled Device Registration and Listing to enter the FURLS Device Registration and Listing Module (DRLM).

Adding And Maintaining FURLS Accounts

FURLS accounts have been created and issued to all current device registration and listing owner/operators and official correspondents. For most establishments, single accounts are all that are needed; however, for owner/operators that have more than one establishment or who have someone other than the owner/operator designated as their official correspondent, multiple accounts are needed.

If the Account Type shown in the letter enclosed with this mailing says “Owner/Operator,” you have been designated as the person who is responsible for your owner/operator’s FURLS accounts and can change registration and listing data for any establishment owned or operated by your company. This means you may create sub-accounts in the FURLS Accounts Management module for other individuals that you need to identify as the official correspondent for each of your establishments. After creating a sub-account in the FURLS Accounts Management module, you can change the official correspondent for the establishment using the “Change the Official Correspondent for a Facility” choice on the DRLM main menu. If your Account Type says “Official Correspondent,” you cannot create sub-accounts and do not have access to any data other than that of the establishment shown on the enclosed letter.

If you are currently a consultant or contractor to an owner/operator and have provided an official correspondent company name and address different from that of the owner/operator in your current registration, you have been given access to and are shown as the contact for the owner/operator. You have also been given a separate account as the official correspondent for the establishment.

Using DRLM

Upon entering DRLM, you will be required to complete the 2008 annual registration for your establishment(s). DRLM will prompt you through this process. Once you have completed your annual registration, you will be able to update your registration and listing data through choices on the DRLM Main Menu, including registering a new establishment, making changes to an existing registration, adding, changing or deleting listings, or reporting the acquisition of an establishment.

Changes To Listing Requirements

When you first log in to FURLS, you may have to replace some listings for your non-exempt products – those requiring premarket approval or clearance before marketing. Previously, these products were listed by their product codes only. Upon launch of the new system, each non-exempt product will be listed separately, even if you manufacture multiple products that share the same product code or codes. There will be a link on the DRLM Main Menu that will take you to a list of the listings for your establishment that will need to be replaced.

Your existing non-exempt listings may also have new listing numbers assigned to them or may have been split into multiple listings. If you have previously listed a product under multiple premarket or 510(k) numbers, each of these premarket submissions will have its own listing in DRLM. If you previously had multiple listings under multiple product codes for the same 510(k) or PMA, these listings have now been combined under a single listing number. You should review all of your listings in DRLM to identify any new listings and listing numbers that FDA has assigned to your products.

So as not to disrupt shipments in transit, your old, superseded listing numbers will remain valid for 30 days after you first access your FURLS DRLM information.

Correspondence Between FDA and Registrants

As part of the change to electronic submission, FDA will begin corresponding with registrants by email rather than paper mail. When you complete your annual registration, please make sure that you have included your email address. If you have previously submitted your email address, please review it carefully to make sure it is correct.

Registration Now Requires Fees For Some Establishments

Certain types of establishment are now required to pay an annual establishment registration fee. They are device manufacturers, contract sterilizers (establishments that sterilize a device for a specifications developer or any other person) who commercially distribute the device, contract manufacturers (establishments that make a device for a specifications developer or any other person) who commercially distribute the device, single-use device reprocessors, and specification developers.

Instructions for paying fees will be posted on the Registration and Listing website and will appear on the confirmation page that will be displayed at the end of your FURLS DRLM session.

If you are required to pay a registration fee for your establishment, you will not be considered registered for 2008 until your payment has been received.

Waivers

Waivers from the requirement to submit device registration and listing information electronically will only be granted in situations where it is not reasonable for the person to be required to do so. FDA interprets this as requiring more than just a lack of an Internet account for the waiver to be granted. The requestor must clearly demonstrate that the Internet is unavailable to them or that it is unreasonable for some other reason. Waiver requests should be mailed to the Food and Drug Administration, Center for Devices and Radiological Health, HFZ-308, 9200 Corporate Blvd., Rockville, MD 20850-4015.