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Device Registration and Listing: An Introduction – Part 2 

Slide 1

Hello! I'm Elias Mallis, Director of the Division of Industry and Consumer Education in the Center for 

Devices and Radiological Health, at the U.S. Food and Drug Administration. Welcome to CDRH Learn, 

FDA's preeminent catalog of multi-media educational modules about medical devices and radiological 

products! In this module, we’re going to focus on one of the most foundational aspects of the medical 

device regulations: Device Registration and Listing. This is Part 2 of this introduction.

Slide 2

Our introduction has so much information to review, we’ve divided this into two parts. 

We encourage you to watch Part 1 before continuing with this module. In Part 1, we covered the 

“what,” the “why” and the “who” involved with registration and listing. We defined several terms and 

principles that we use in Part 2. And importantly, after watching Part 1, you should know if you’re 

required to register and list. If the answer is yes, then you’re ready for Part 2. Let’s learn how to 

complete this process.

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In this module, we’re going to cover several learning objectives. We’ll first list the steps you need to 

register your establishment. We’ll then review the information you need to list your devices. We’ll then 

discuss how you use the electronic systems to register and list – that is, FURLS and DRLM. And we’ll get 

into the details of user fees.

Slide 4

So, let’s start out with a review of the steps to register your establishment. Please make sure to follow 

these in order.

Slide 5

The first few steps apply to all establishments, whether you are domestic or foreign. The first step is to 

pay the annual registration user fee. You can’t start the establishment registration process before FDA 

has received and processed your payment. 

The second step is to register your establishment in the FDA Unified Registration and Listing System, 

more commonly known by its acronym, FURLS. FURLS is the electronic system that the FDA uses for 

registration and listing. Once in FURLS, you’ll then select the Device Registration and Listing Module, or 

DRLM, to complete the process for registering your establishment.

Slide 6 

In Step 3, you’ll now need to provide the necessary information about your establishment. This includes 

the name of the establishment, the owner operator, and official correspondent. You’ll also provide your 

contact information, establishment website address if you have one, and any trade names used by your 

establishment.

Slide 7

Now for this 4th step, if this is your initial registration and you are not an initial importer, you’ll need to 

create at least one device listing. Any device you intend to list must be legally marketed. For the most 

part, this will mean that the device is either exempt from a premarket submission, or that you’ve 

submitted a submission and received marketing authorization on your device from the FDA. For 
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example, substantial equivalence for a premarket notification or 510(k); approval of a premarket 

approval, or PMA; approval of a humanitarian device exemption, or HDE, or granting order for a De 

Novo Classification Request.

Slide 8

Now at Step 5, you provide all proprietary names under which your device is marketed in the United 

States. You may mark this information as “confidential” so that the name will not publicly display in the 

FDA’s public registration and listing database. 

Slide 9

These remaining two steps apply only to foreign establishments. In Step 6, you identify all persons you 

know who import, or offer for import, your product into the United States. 

In Step 7, you identify a U.S. Agent who must confirm that they are the U.S. Agent for you as a foreign 

establishment. Please note that if this is not done, the FDA may place your establishment in a “failed to 

register” status.

Slide 10

Now, if you’re an initial importer, your sixth and final step is to identify the manufacturer of the device 

that you’re importing. You may either provide the device listing, if known, or provide the manufacturer’s 

name. Note that the manufacturer should already be in FURLS because they should have already 

registered themselves and identified you as the importer as part of their registration. Note that FDA 

does not provide device listing information to an importer, so you’ll need to get this information from 

the manufacturer directly. 

Slide 11

Let’s now talk a little about the United States Agent, or the U.S. Agent. The U.S. Agent assists the FDA in 

communicating with a foreign establishment. The foreign establishment grants the U.S. Agent the 

authority to act as their official correspondent. The Agent will receive official FDA information or 

documents and will respond to questions from the FDA about devices being imported. 

Slide 12

The U.S. Agent must reside or have a place of business in the United States. Note that the address 

cannot be a Post Office Box, or P.O. Box. The Agent has no responsibility to report adverse events nor 

responsibility to submit marketing submissions. Foreign establishments should update any changes to 

their U.S. Agent in FURLS and DRLM within 10 business days. 

Slide 13

Now that we’ve reviewed the steps to register, let’s go over the information you’ll need to list your 

medical device.

Slide 14

You’ll need your establishment registration number and name. You’ll need to identify the activities that 

are performed at your establishment, such as manufacturing or labeling. 

And you’ll need to provide some regulatory information about your medical device. If your device is 

exempt from a premarket submission, or is considered Pre-Amendments, that is, in distribution prior to 

May 28, 1976, then you’ll provide the product code for the device. Otherwise, we’ll generally need the 
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premarket submission number, whether it be a 510(k), PMA, De Novo, or Humanitarian Device 

Exemption. Examples of those submission numbers are listed here. Please note that you’ll list a device 

only after you have received marketing authorization from FDA.

Slide 15

We have a few other details involving device listing. Each device listing that you successfully create will 

generate its own unique listing number. However, all establishments under a given owner operator will 

share the same listing number. 

Note that you cannot create a new device listing in a few situations: (1) for multiple exempt devices with 

the same product code, except for manufacturers of export only; and (2) for multiple non-exempt 

devices with the same premarket number, under the same registration. 

Slide 16

All establishments that must register must also list their devices. The only exception is for initial 

importers, who are not required to list. Foreign establishments must list their device before it may be 

imported into the United States. The device list sequence is, first, manufacturer or specification 

developer, and second, contract manufacturer or contract sterilizer. And for combination products, 

please identify the combination type for your product, for example, “device-biologic” or “device-drug.”

Slide 17

Let’s now get into the details of accessing the FURLS and the DRLM systems.

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So what is FURLS? FURLS is an acronym that stands for FDA Unified Registration and Listing System. This 

is the web-based, online system to electronically submit information to the FDA. A link to FURLS is listed 

on the bottom of this slide. Once you’re in FURLS, you’ll select the Device Registration and Listing 

Module, or DRLM.

Slide 19

In rare situations, you may request a waiver from completing your registration and listing through the 

FURLS electronic system. To do so, we prefer that you email your waiver request to the CDRH FURLS 

Team at the email address listed here. Alternatively, you may send us a letter to the mailing address 

listed here.

Slide 20

Please explain why you’re not able to electronically submit this information. FDA will then notify you if 

the waiver to submit electronically is granted. Please note that you’re still required to pay the user fee 

that’s due annually. 

Slide 21

We have two FURLS account types: owner/operator and official correspondent (or OC). This is a good 

place for an important note that the FURLS account is not the same as your user fee account. Make sure 

to keep these accounts separate from each other, as you’ll need each of them. 

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An important thing to keep in mind is your FURLS account password. You’ll be required to change this 

password every 90 days and you’ll need your current password to make the change. If you’ve forgotten 
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your current password, first try to recover it by clicking the “Forgot Password” link on the login home 

page. You’ll need your Account ID as well as the answer to your secret question. If this doesn’t work, 

then please reach out to the CDRH Registration and Listing Help Desk for assistance. The team’s email 

address is listed here. As a gentle reminder, please do not attempt to create a new FURLS account if 

you’ve forgotten your password. We’ll help you to re-set your password if you have any problems. 

Slide 23

Let’s now get to the two account types, first starting with the owner/operator. The owner/operator 

account is often referred to as the “enterprise” or “primary account.” The owner/operator is assigned to 

the corporation or proprietor directly responsible for the activities of the registered establishment. The 

owner/operator may create new FURLS sub-accounts and official correspondent accounts. They may 

also create, update, and deactivate registrations and listings. 

Slide 24

The second type of account is the “official correspondent”, and this is the one created by the first one 

we just reviewed – the “owner/operator”. The official correspondent may complete the registration and 

listing information for any establishment that is under their responsibility. The official correspondent 

may create new, or update and cancel existing, registrations and listings assigned to them. They may not 

change any owner/operator or official correspondent information, as this may be done only by the 

owner/operator.

Slide 25

This slide shows how an owner/operator may create multiple official correspondent accounts, each of 

which may be responsible for one or more establishments. Starting from the top left circle, we have the 

owner/operator. The owner operator here has created an owner operator account and several official 

correspondent accounts.

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In order to tell what type of account you have, you can log into FURLS and look for “Edit Account Profile” 

on the Account Management Menu. If you see the “Edit Account Profile” button, then you‘re signed in 

as the owner operator.

Slide 27

Let’s conclude our introduction to registration and listing and Part 2 with a review of user fees for 

establishment registration.

Slide 28

Most importantly, all establishments that are required to register must pay the establishment 

registration user fee. There are no waivers, reductions, or exemptions. To pay the user fee, set up or 

access your user fee account that’s on the Device Facility User Fee website, or DFUF. A link to the 

website is listed at the bottom of this slide. 

Remember, the FURLS and user fee accounts are not the same. They have different IDs and passwords, 

so please make sure to track these carefully and individually.

Slide 29

After you paid the annual registration user fee, FDA will email you a payment identification number, or 

PIN. And after your payment has been fully processed, FDA will email you a payment confirmation 
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number, or PCN. You’ll need both the PIN and PCN to complete your FURLS registration, so please keep 

a record of these items. 

After you receive your PCN, you may then register your establishment in FURLS. Please don’t attempt to 

start your registration before you have both the PIN and PCN. You won’t be able to save any information 

that you complete, and you’ll need to re-enter everything when you get back into the system. 

Slide 30

The user fee amount usually changes each year and is set by statute. The user fee cycle runs on a fiscal 

year, so it runs from October 1 of the current year through September 30 of the next year. I encourage 

you to go to the website listed here to find the user fee for the current fiscal year.

Slide 31

FDA offers several methods for you to submit your payment. First, you may pay electronically, with a 

credit card or automated clearing house electronic check. You can also choose to mail a paper check. If 

you do so, please make sure the check is drawn on a U.S. Bank in U.S. currency. Make the check payable 

to “Food and Drug Administration” and make sure to include the PIN. And finally, you may pay with a 

wire transfer. Keep in mind that you’ll need to pay any wire transfer fees if you choose this method.

Slide 32

We’ve covered a lot of information on the overview of the registration and listing process. If you have 

any further questions about this process, please email the FDA Team at: reglist@cdrh.fda.gov. 

Now if you have any specific policy questions or import detention issues, please email the second email 

address listed here: Device.Reg@fda.hhs.gov. 

Slide 33

On this slide, we’ve listed some of the resources that we referenced during this presentation. Please 

keep this handy in the future. 

Slide 34

As I’ve mentioned, this is Part 2 of our two-part overview of the Registration and Listing Introduction. 

Now that you’ve watched these modules and understand the overall process, you’re ready for our other 

CDRH Learn modules to help you successfully complete your establishment registration and device 

listing. If this is your initial, or first, registration, please go to our instructional guide on the top link. If 

this is your annual registration, then go to the bottom link for that CDRH Learn module instead. This is 

an important process for all establishments, so we’re here to guide you through it! 

Slide 35

Let’s now recap what we discussed in this module. First, an establishment follows a series of steps to 

complete the establishment registration. Specific information is needed to complete the device listing, 

and FURLS is the online electronic system that you’ll use to complete this process. FURLS account types 

are either “owner/operator” or “official correspondent”. And finally, establishments use the DFUF user 

fee system to pay the required annual registration user fee, and then complete establishment 

registration.

Slide 36

We in the Division of Industry and Consumer Education provide you with regulatory education in several 

key formats, so you can choose the most effective way you wish to learn. CDRH Learn consists of over 
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200 multi-media industry education modules, such as the one that you’re watching here. These include 

videos, webinars, presentations, and various “how to guides.” Use your computer, phone, or portable 

device to click on the link shown here. Now, if you prefer to learn by reading, check out Device Advice! 

Device Advice consists of several hundred pages of comprehensive regulatory information across the 

device total product life cycle. And finally, if you have a specific question and wish to ask us directly, I 

encourage you to call or email us. Our contact information is listed here, and we look forward to 

speaking with you.

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Let’s conclude this module with your call to action. First, learn the steps you’ll need to successfully 

register your establishment and to list your devices. Second, make sure to pay your user fee before you 

register and list. And finally, use the FDA educational resources to help you complete the initial and 

annual registration process. We’re here to help. Thank you for your attention to the module “Device 

Registration and Listing, An Introduction, Part 2.” Take care and we’ll see you next time!

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