Device Registration and Listing:

An Introduction – Part 2

Elias Mallis

Director

Division of Industry and Consumer Education

Office of Communication Education

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Device Registration and Listing 

Introduction

• Part 1:

– What, Why, and Who is involved with registration and listing

• Part 2:

– How to register and list

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Learning Objectives

• List the steps to register

• Identify information needed to list

• Discuss how to use FURLS and DRLM

• Explain how user fees are paid

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Steps to Register

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Registration and Listing Steps:

Domestic and Foreign Establishments

1. Pay annual registration user fee

– Can’t start establishment registration process before FDA has received and 

processed the fee

2. Register establishment in FURLS 

– Select DRLM and register establishment

FURLS = FDA Unified Registration and Listing System

DRLM = Device Registration and Listing Module

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Registration and Listing Steps:

Domestic and Foreign Establishments

3. Provide necessary information

– Establishment, owner operator, and official correspondent

– Name, address, phone, fax number and email

– Establishment website address, if any

– Trade names used by establishment

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Registration and Listing Steps:

Domestic and Foreign Establishments

4. Create at least one device listing, at time of initial 

registration

– Device must be legally marketed before listing such as:

• Exempt

• Premarket Notification [510(k)]: Substantially equivalent or “cleared”

• Premarket Approval [PMA] or Humanitarian Device Exemption: Approved

• De Novo Classification Request: Granted

 Note: Excludes initial importers

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Registration and Listing Steps:

Domestic and Foreign Establishments

5. Identify all proprietary names

– Under which device is marketed in United States

– May mark as “confidential” so name will not publicly display 

in public registration and listing database

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Registration and Listing Steps:

Additional for Foreign Establishments Only

6. Identify all persons you know who import (or offers for 

import) your product into United States

7. Identify a U.S. Agent

– Agent must confirm that they are the U.S. Agent for the foreign 

establishment

– If not completed, FDA may designate as “failed to register”

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Registration and Listing Steps:

Additional for Initial Importers Only

6. Identify manufacturer of device you import

– Either device listing, if you know; OR

– Manufacturer’s name

• Manufacturer should already have registered in FURLS and identified importer 

during registration

→ FDA does not provide device listing information to importers 

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United States Agent

• Assists FDA to communicate with Foreign Establishment

• Granted authority by Foreign Establishment to act as their 

official correspondent

• Receives official FDA information or documents

• Responds to questions about imported devices

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United States Agent

• Must reside or have place of business in United States

– Cannot use Post Office (P.O.) Box for address

• Has no responsibility to report adverse events

• Has no responsibility to submit marketing submissions

 Note to Foreign Establishment:

 Update changes to your U.S. Agent in FURLS/DRLM within 10 business 

days

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Listing Your Medical Device

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Information Needed to List Device

• Establishment registration number and name

• Activities performed at establishment

– Examples: manufacturing, labeling

• Regulatory Information:

– Product Code: if your device is exempt from premarket submission or 

in distribution prior to May 28, 1976 (“Pre-Amendments”)

– Premarket submission number: if not exempt or Pre-Amendments

• Examples: K239999; P239999; DEN239999; H239999

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Device Listing: Additional Details

• Each successfully-created listing generates a unique listing number

• All establishments under owner or operator may share same listing 

number

• Cannot create a new device listing for:

– Multiple exempt devices with same product code

• Except for manufacturers of export only

– Multiple non-exempt devices with same premarket number, under same 

registration

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Device Listing: Additional Details

• All establishments who must register must also list their devices

– Exception: Initial Importers are not required to list

• Foreign establishments

– Must list device before it may be imported into United States

• Device List Sequence

– First: manufacturer or specification developer

– Second: Contractor manufacturer or contract sterilizer

• Combination products – identity “type” of combination

– Examples: “Device-Biologic”, “Device-Drug”

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Using FURLS and DRLM

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FURLS and DRLM

• FDA Unified Registration and Listing System (FURLS)

– Web-based, online system to electronically submit 

information

– From here, select Device Registration and Listing Module 

(DRLM)

www.access.fda.gov/oaa/logonFlow.htm?execution=e2s1

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Waiver of Electronic Submission

• Submit request to CDRH FURLS Team:

– Email to: Device.Reg@fda.hhs.gov (preferred); or

– Mail letter to:

Imports and Registration and Listing Team

Division of Regulatory Programs 2

Office of Regulatory Programs

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue, Building 66, Room 1432

Silver Spring, MD 20993

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Waiver of Electronic Submission

• Explain why unable to electronically submit 

information

• FDA will notify if waiver is granted:

– Note: You are still required to pay user fee

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FURLS Account Types

• Owner/Operator

• Official Correspondent (OC)

 Important Note: 

– FURLS account is different from a User Fee account

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FURLS Account Password

• Must change every 90 days

– Need current (old) password to make change

• If you forget password:

– First attempt to recover with “Forgot Password”

– Need Account ID, Secret Question and Secret Answer

• If “Forgot Password” doesn’t work and you need help:

– Contact CDRH R&L Help Desk (reglist@cdrh.fda.gov)

– Do not create new FURLS account; FDA will guide you

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Owner/Operator Account

• “Enterprise” or “Primary Account”

• Corporation or proprietor directly responsible for 

activities of registered establishment

• Creates and updates all FURLS sub-accounts, official 

correspondent accounts, registrations and listings

• Deactivates registrations and listings

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Official Correspondent Account

• Assigned by owner/operator

• May complete registration and listing for any 

establishment under responsibility

• May create new, update, and cancel registration and 

listing assigned to them

• May not change owner/operator or official correspondent 

information

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Owner / 

Operator

Account

“Primary Account” • Create, edit and delete 

any account

• Add, delete or change 

R+L information 

OO Account

#1

OC Account

#2 “Sub-Account”

• Add, delete or change 

R+L information under 

its responsibility

OO Account

#1

OC Account

#1

OC Account

#2

Registered Establishment

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Owner / 

Operator

Account

OO Account

#1

OC Account

#1

OO Account

#1

OC Account

#2

OC Account

#2

“Primary Account” • Create, edit and delete 

any account

• Add, delete or change 

R+L information 

• Add, delete or change 

R+L information under 

its responsibility

Registered Establishment

“Sub-Account”

To find out what type of account you have:

1. Log into FURLS

2. Go to Account Management Menu

3. Look for “Edit Account Profile”

4. If you see “Edit Account” profile button, then you are 

signed in as Owner/Operator 26
User Fee for

Establishment Registration

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Establishment Registration User Fee

• All establishments required to register must pay establishment 

registration user fee

• To pay fee:

– Set up/access your user fee account on Device Facility User Fee (DFUF) 

website

 Important Note: Your FURLS and DFUF Accounts are not the 

same; they have different ID and passwords

DFUF Website: userfees.fda.gov/OA_HTML/furls.jsp

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Paying User Fee Then Register

1. After you pay annual registration user fee, FDA will 

email you:

– Payment Identification Number (PIN) and

– Payment Confirmation Number (PCN)

2. After you receive your PCN, register establishment 

in FURLS:

– Need to use both PIN and PCN to complete

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Establishment Registration

User Fee: Amount

• Congress establishes the user fee amount

• Set for each fiscal year

– From October 1 of current year through September 30 of next year

• Current Fiscal Year User Fee:

www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

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Establishment Registration

User Fee: Payment Methods

• Electronic payment

– Examples: Credit cards or automated clearing house electronic checks

• Mailed paper check

– Drawn on a United States Bank in U.S. currency

– Make payable to “Food and Drug Administration”

– Include the PIN

• Wire transfer

– Establishments are responsible for paying all wire transfer fees

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For Questions

• Registration and Listing Process or FURLS/DRLM

– RegList@cdrh.fda.gov

• Policy or Import Detention Issues

– Device.Reg@fda.hhs.gov

Registration and Listing Process or FURLS/DRLM

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Policy or Import Detention Issues

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Resources

Slide 

Number

Cited Resource URL

18 FURLS www.access.fda.gov/oaa/logonFlow.htm?execution=e1s1

26 DFUF userfees.fda.gov/OA_HTML/furls.jsp

28 Device Advice: Device Registration 

and Listing

www.fda.gov/medical-devices/how-study-and-market-yourdevice/device-registration-and-listing

FURLS

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DFUF

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Device Advice: Device Registration and Listing

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Other Related CDRH Learn Modules

• FURLS Device Registration and Listing Module for Initial 

Registration

www.accessdata.fda.gov/cdrh_docs/presentations/FURLS/story.html

• FURLS Device Registration and Listing Module for Annual 

Registration

www.fda.gov/media/107672/download

FURLS Device Registration and Listing 

Module for Initial Registration

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FURLS Device Registration and Listing 

Module for Annual Registration

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Summary

• An establishment follows a series of steps to complete establishment 

registration

• Specific information is needed to list devices

• FURLS is the online electronic system used to complete this process

• FURLS Account types include Owner/Operator, Official 

Correspondent

• Establishments use the DFUF user fee system to pay the required 

annual registration user fee and then complete registration

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Industry Education

1. CDRH Learn – Multi-Media Industry Education

 over 200 modules - videos, webinars, presentations, software-based “how to” modules

 accessible on your portable devices: www.fda.gov/CDRHLearn

2. Device Advice – Text-Based Education

 comprehensive regulatory information across the device total product life cycle: 

www.fda.gov/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Email: DICE@fda.hhs.gov

 Phone: 1-800-638-2041 or (301) 796-7100 (Live Agents 9 am – 12:30 pm; 1 – 4: 30 pm ET)

CDRH Learn

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Device Advice

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Email DICE

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Your Call To Action

• Learn the steps to successfully register your 

establishment and list your devices

• Pay your user fee before you of register and list

• Use the FDA educational resources to help you 

complete the initial and annual registration process

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