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FAQs about Account Creation - Medical Device User Fee

Posted Date:2019/2/13

3. How do I create an account for a new organization?

To register for a new user account with the Food and Drug Administration (FDA) User Fee System and create/submit a Medical Device User Fee cover sheet for an application and fee payment, you must provide the FDA with information about your organization.  When you are ready to register a new user account follow the process detailed below.

 Click on MDUFA User Fee website and agree to the disclaimer.

 Click on Medical Device User Fee Registration link, under heading New User, please register.

 Search to find your existing organization, using only ONE field at a time.  Click the 'Search' button to find your organization. 

 If your organization exists in the FDA User Fee website, your company name/address will be displayed.

 If your organization does not exist, 'Your search did not produce any results' will be displayed.  Click 'Continue' button I am unable to find my organization using the search options above.

 To search for your organization using the Dun & Bradstreet database, enter the Business Name, Duns Number, City, State, and Country.

 To manually register your organization, click the 'Manual Input' button to proceed.

 If your organization is not registered in the FDA User Fee website, you must register by providing the FDA with the following information:

1.  Employer Identification Number (EIN) - for domestic organizations only

2.  Data Universal Numbering System (DUNS) number - required for foreign organizations

3.      Contact Name

4.      Company Name

5.      Address, including City, State, Zip Code and Country

6.      Email Address

7.      Daytime phone number

 The following information is needed to create a user account:

1.  Contact Name

2. Email Address

3.   Daytime Phone Number 

4.   User Name - any User Name; however, must not exist already

5.       Password - any Password you choose that follows the parameters listed

After you have registered and created a user name and password, you will receive a confirmation email.  You may then access the FDA User Fee website using the new user account.

4.I am a new user; however, someone from my organization has already created an account.  How do I proceed?

If your organization exists in the FDA User Fee website you can use the steps below to search for your organization and create a new user account under the existing organization.  When you are ready to register a new user account follow the process detailed below.

 Click on Medical Device User Fee Registration link, under heading New User, please register.

 If your organization is already registered in the FDA User Fee website, you can search for your existing organization using only ONE of the search fields at a time below:

 FDA assigned Organization Number

 Employer Identification Number (EIN)

 Dun and Bradstreet - Data Universal Numbering System (DUNS)

 Previous paid Invoice Number, Cover Sheet Number, or Payment Identification Number (PIN)

 Email Address

 Click the 'Search' button to find your existing organization account

 If your organization does not exist, 'We can not find your company based on the information.." will be displayed. Refer to Question #3 - Account Creation to proceed with creating a new organization.

 If your organization exist in the User Fee website, your company name/address will be displayed

l If your organization information is found, click the 'Select' button to continue and create a user account.  The following information is needed to create a user account:

1.  Contact Name 

2. Email Address 

3.  Daytime Phone Number 

4.  User Name - any User Name; however, must not exist already

5.  Password - any Password you choose must meet the parameters listed

5. What is an Organization number?

The organization number (Org ID) uniquely identifies your business in the FDA User Fee website.  The Org ID enables FDA to track your payments for the cover sheets received for the review of MDUFA applications that you submit.  The Org ID is a system generated number assigned to a new organization during the registration process. 

Please contact the User Fee Helpdesk at userfees@fda.gov or (301) 796-7200 to retrieve your organization number (Note: be prepared to provide your organization name and address).

6. What is an Employer Identification Number (EIN)?

An Employer Identification Number (EIN), also known as a Federal Tax Identification Number, is a nine-digit number issued by the U.S. Government to uniquely identify an organization as a business entity.  All U.S. organizations must have EIN numbers to conduct business with the U.S. Federal Government and pay taxes.  If you are a U.S. individual and have not applied for an EIN, you must use your Social Security number (SSN).  To obtain an EIN, you may navigate to the Internal Revenue Service website, click the 'Businesses' link, and select the 'Employer ID numbers' link.  If you are an international organization, please obtain a DUNS number (see question 7 for more information) prior to initiating your Medical Device User Fee cover sheet registration process.

7. What is a DUNS number, and how do I obtain one?

A Dun & Bradstreet Data Universal Numbering System (DUNS) number is the standard for keeping track of the world's businesses.  The Food and Drug Administration uses DUNS numbers to uniquely identify foreign organizations because the Employer Identification Number (EIN) is usually assigned to U.S organization only.  The DUNS number is required for foreign organizations to register in the User Fee Website. 

Obtaining a DUNS number is fast, easy, and free.  To obtain a DUNS number, please contact Dun & Bradstreet at 1-800-234-3867; or you can request a number via email at the website http://www.dnb.com.

8. What is an Agent?

An Agent or consultant is an organization or an individual that has the authority to represent another organization.  The agent has the authority to create cover sheet(s) and/or make payment(s) on behalf of another organization.  If a payment is made on behalf of another organization, an Agent is required to reference the Payment ID number (PIN) on the payment submission.

The information provided on the cover sheet is for payment purposes only.  If you are an agent or consultant creating a cover sheet for a different company please provide the details for the organization paying the fee.  If there are any payment issues, the FDA will contact the organization listed on the cover sheet.

9. How do I qualify as a Small Business?

Each fiscal year your company must qualify for a Small Business Decision (SBD) number to be granted discounted user fees.  Click here to learn more about how to qualify as a Small Business.  You must have a valid SBD number for the current fiscal year before you can create a cover sheet for a discounted fee.

Contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at (301) 796-7100 or email dsmica@fda.hhs.gov for questions regarding qualifying for Small Business waivers.