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  6. Registration and Listing Payment Process
  1. Device Registration and Listing

Registration and Listing Payment Process

All establishments required to register must first visit the Device Facility User Fee (DFUF) website to pay the registration user fee, unless a registration fee waiver has been granted. When you submit your order in the DFUF website, you will receive your Payment Identification Number (PIN) by email. After you pay the registration user fee and your payment is processed, you will then receive your Payment Confirmation Number (PCN) by email. This typically takes several days so please plan to submit your payment in advance of when you need to complete your registration.

Once you receive your PIN and PCN, you can proceed to the FDA Unified Registration and Listing System (FURLS) website to submit your registration and listing information electronically in the FURLS/ Device Registration and Listing Module (DRLM) database using Online Account Administration (OAA).

Your registration is not considered complete until your PIN and PCN has been used or applied to a registration in FURLS/DRLM database.

The FDA no longer accepts paper checks. You can submit payment online [by credit card or Automated Clearing House (ACH) electronic check (eCheck)] or by bank wire transfer. Electronic Payment and Wire Transfer information can be found on this User Fee Payment Information link.

Individuals, corporations, or other public or private entities that qualify for an exemption from the use of electronic funds transfers should reach out to the User Fess Support Staff at OO-OFBA-OFM-UFSS-Govenment@fda.hhs.gov for assistance.

Step-by-step instructions for paying the registration user fee to register an establishment at FURLS/DRLM can be found at FURLSCScreation.pdf.

IF YOU HAVE GENERAL DEVICE QUESTIONS, PLEASE CONTACT:

Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

DICE@fda.hhs.gov
(800) 638-2041
(301) 796-7100

CDRH, Office of the Center Director

 

IF YOU NEED REGISTRATION AND LISTING ASSISTANCE, PLEASE CONTACT:
reglist@cdrh.fda.gov

IF YOU NEED REGISTRATION USER FEE ASSISTANCE, PLEASE CONTACT:
The User Fee Helpdesk at userfees@fda.gov

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