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U.S. Department of Health and Human Services

Training and Continuing Education

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Presentation: Device Establishment Registration & Listing

(This presentation is also available in video format with captioning and PDF printer-friendly format.)

CAPT David Racine
Food and Drug Administration
Center for Devices & Radiological Health
Office of Compliance

Device Establishment Registration and Listing

  • Purpose
    • Review the regulatory requirements for Device R&L under CFR21 Part 807, FDAAA
  • What we will cover
    • User Fees
    • What is Registration and Listing
    • Who has to register

What we will cover

  • Who has to list
  • When and How to Register, List and Pay the User Fee
  • Electronic Registration Accounts

Regulatory Authority

  • Section 510 of the Food, Drug and Cosmetic Act As Amended requires establishment registration and device listing
  • Regulation - 21 CFR Part 807, subparts A-D
    1. Definitions
    2. Procedures for Domestic Device Establishments
    3. Registration Procedures for Foreign Device Establishments
    4. Exemptions

Electronic Registration and Listing

The Food and Drug Administration Amendments Act of 2007 (FDAAA) mandated use of electronic system and introduced annual registration user fee for many types of establishments, beginning October 1, 2007

  • Firms subject to the establishment registration user fee must pay first
  • Web-based entry of registration and listing information
  • Registration not accepted until both steps completed

Annual Registration User Fees

  • Congress has established a schedule of annual registration user fees for each fiscal year as shown below
    • FDA does not have the authority to waive or reduce the fee for anyone, including small businesses

FY08: $1706
FY09: $1851
FY10: $2008
FY11: $2179
FY12: $2364

Waivers to Electronic Registration & Listing Submission

  • Waivers are granted from submitting R&L information electronically
  • To apply you must provide a complete explanation of why you cannot submit your information through the Internet.
  • Note: if you are granted a waiver, you will still be responsible for the establishment registration fee (if required to pay).

Establishment Registration & Listing

  • Registration and listing provides FDA with the location of medical device establishments and the devices that are manufactured, prepared, propagated, compounded, assembled, or processed at those establishments.

Who Has to Register

(Complete chart of who must register, list & pay on website & end of slides)

  • Domestic
    • Manufacturers
    • Repackagers / Relabelers
    • Contract Manufacturers/Sterilizers who commercially distribute
    • Kit Assemblers
    • Specification Developers
    • Initial Importers (Initial Distributors)
    • Reprocessors of Single Use Devices
    • Remanufacturers
  • Foreign (if their devices are sold in the US)
    • Manufacturers
    • Contract Manufacturers/Sterilizers
    • Reprocessors of Single Use Devices
    • Repackagers/Relabeler
    • Kit Assemblers
    • Specification Developers
    • Remanufacturer
    • Exporters

Who Has to List

  • Any establishment required to register also has to list with the exception of initial importers/distributors

When to Register & List

  • Initial/First Time Registration
    • Register your domestic establishment and List your devices within 30 days of putting them into commercial distribution
    • Do NOT register and list BEFORE your 510(k) application is cleared for marketing by FDA
    • Initial Importers are NOT required to List
    • Register your foreign establishment and List the devices prior to exporting to the US for the first time
  • Annual Registration
    • All firms must certify that their registration information is complete & accurate on an annual basis during the last 3 months of each year (10/1 to 12/31)
    • Establishments that are required to list devices must certify their listings during the same period

How to Register & List

  1. Pay the Establishment Registration Fee only if required to do so. If you are not required to pay the fee, skip to step #2. You pay the fee by accessing your user fee account on the Device Facility User Fee website (DFUF) . Note this is a different account than what you use to complete your electronic R&L.
  2. Submit Registration and Listing Information Electronically OR
  3. Apply for a Waiver to Electronic Registration if you do not have access to the Internet. Note: you will be responsible for paying the fee (if required to pay)

When to Submit Registration & Listing Information

  • You must submit/certify Registration and Listing information during:
    • Annual Registration Period (10/1 – 12/31)
    • Initial/First Time Registration
  • You may submit changes to R&L information at any other time during the FY
  • To submit information you will need a FURLS account ID and password

FURLS Accounts

  • There are two types of FURLS accounts:
    • Owner Operator
    • Official Correspondent
  • Your FURLS account is different than your User Fee account
  • Your FURLS password has to be reset every 6 months – system will notify you
  • A establishment should not create a new FURLS account if the establishment was registered with FDA in the past, unless directed by FDA.
  • If you forget your password, try the reset password function first.

FURLS Accounts

  • Owner Operator Account (OO)
    • Assigned to the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registered establishment.
    • Creates and updates all FURLS accounts.
    • Creates, Updates and Deactivates registrations and listings.
  • Official Correspondent
    • The person designated by the owner/operator who is responsible for the annual registration and device listing.
    • Create new registrations and listings
    • Make changes, updates and cancellations to registrations and listings that have been assigned to them
    • Cannot change the owner operator or official correspondent information (name, address, telephone, email etc.)

OO Account - Master Account - Can Create, Edit & Delete any account. Can Add, delete or change R&L info

OC Account - Sub Account - Can Add, delete, or change R&L information under its responsibility

Site - Registered Establishments

FURLS Accounts

Q. How do I know which type of account I have?

A. When you log into FURLS look on the left hand side of the screen. If you see a button that says Edit Account Profile, you are logged in as the owner operator. If you do not see that button, you are logged in as the official correspondent.

(Screenshot of FURLS, highlighting Create New Account button on left, and AccountID and Password boxes on right)

(Screenshot of FURLS, highlighting Edit Account Profile button on left)

What Information Do I Need to Register & List

  • Information about the Owner Operator (name, address, phone, email)
  • Information about the Official Correspondent – If different then OO (name, address, phone, email)
  • Information about the Establishment (name, address, etc.)
  • For Foreign Establishments – Information about their US Agent

US Agent

  • Assist FDA with communicating with the foreign establishment.
  • Accept information or documents that FDA is unable to provide directly to the foreign establishment
  • Respond to questions concerning products being imported or offered for import
  • May act as Official Correspondent if so designated by the foreign establishment
  • US agent has no responsibility related to reporting adverse events or submitting 510(k) notifications
  • Must reside in the United States and not be a PO box address

What Information Do I Need to List?

  • Type of Product
    • For Exempt Products – Give us the Product Code
    • For Non Exempt Products – Give us your 510(k), PMA, NDA, HDE or PDP number and we display the product code
  • Proprietary Names (optional)
  • Activity Associated with that product at a particular establishment
    • (Example – manufacturer, specification developer, repackager, etc.)

More About Listing

  • Basic Parts of Every Listing:
    • What kind of device? (product code or premarket number)
    • At which establishment?
    • What activity on that device at that establishment?
  • Each listing creates a Listing Number
  • All of the establishments under an owner operator can share the same listing. You can’t enter a new listing for an exempt device (by product code) or a non exempt device (by premarket number) that you already had listed.

Modifying a Listing

(Diagram showing D876578 (K768795) (ABC) connected to Facility #1: Manufacturer, Facility #2: Specification Developer, and connected via Modify to Facility #3: Repackager)

To add a new establishment to a listing, you modify the existing listing instead
of creating a new listing.

About our Facilities FY09

  • Domestic Establishments
    • 11,000
    • 3,600 of them are initial importers only
  • Foreign Establishments
    • 7,740
    • 670 are foreign exporters

For Additional Information

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