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U.S. Department of Health and Human Services

Medical Devices

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Instructions for Paying the FY 2009 Device Establishment Registration Fee and Completing the Annual Registration (10/08)

Instructions for how to pay your fee

We are using a new payment process to collect the establishment registration fee for 2009. You do not have an account for this new payment process.

You have to set up a new account in the Device Facility User Fee (DFUF) website.

Here are the instructions that you need to set up a new account:

  1. Go to the Device Facility User Fee website: https://userfees.fda.gov/OA_HTML/furls.jsp
    Once at this website, please click on “I am here for the first time to pay for my 2009 Establishment Registration Fee”
  2. Enter the information to create your new account to enter the website. Domestic firms must enter their taxpayer ID.
     
    You will create a username and password. Be sure to write down you username and password. You will need to use it to log into the system again to retrieve your PCN.
     
  3. Click the “Go” button next to the “Establishment Registration User Fee for 2009”.
  4. Make sure the correct quantity appears in the box and click “Add to Cart”.
  5. Review the billing information. If no address appears in the billing information section, select Add/Edit Address.
  6. Click “Next”.
  7. Submit your order and receive a Payment Identification Number (PIN) online
  8. Submit your payment – click here to read about the various payment options available to you
  9. Receive a payment confirmation email when payment is processed.
  10. Access your Payment Confirmation Number (PCN) by following the instructions listed below.

Instructions for how to retrieve your PCN

  1. Go here: https://userfees.fda.gov/OA_HTML/furls.jsp
  2. Choose: I am returning to the User Fee website to retrieve my PCN or create a new PIN
  3. Log in with your username and password that you used to place your order.
  4. Look for the box that says: Establishment Registration User Fee 2009 – FURLS Device Facility User Fee and Click on the GO button.
  5. At the top of the screen look for previous orders/PCN.
  6. Click on that link.
  7. Then click on your order number link to open up a screen that shows your PCN.

It will be located in section 4 at the bottom of that screen. It takes a while to load so be patient.

Annual Registration

  1. If you are required to pay the establishment registration user fee (See Who Must Register, List & Pay the Fee), you must first visit the Device Facility User Fee website to pay the user fee. Once you make payment and receive your confirmation numbers for your payment (PIN/PCN), proceed to the next step.
  2. Use your FURLS account ID and password that you used last year to log on to our site at: https://www.access.fda.gov/oaa/
  3. Select the DRLM button (Device Registration and Listing Module)
  4. Select the Annual Registration link. Note: You must select the Annual Registration link and complete that process in order for your establishment to be considered registered for FY 2009
  5. Review the registration information for your establishment and make any updates
  6. Review your listing information (if you are required to list your devices) and make updates
  7. Certify that the information is correct and submit.
  8. If you are prompted to enter payment confirmation numbers (PIN/PCN), you must enter this information for FDA to accept your registration. Without these numbers (if prompted), your registration is incomplete and you will have to enter your information again. Your registration is not considered complete until you have paid your registration user fee (if required to do so), submitted your information electronically, and have received notification from FDA that all requirements have been met.