The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting the public health and accelerating innovation in the industry. The Office of Financial Management (OFM) is responsible for the financial management of the user fee programs. OFM maintains an accounts receivable system used for user fee invoicing, collections, reporting, and data maintenance.
To the left are links to all of the FDA’s user fee programs.
The cover sheet creation process gathers the minimum amount of information necessary to determine whether a fee is required, to determine the amount of the fee, and to allow FDA to track payments. Industry users can click on the user fee program link directly below to create and pay for the cover sheets. Users require a user name and password to proceed once they get to the cover sheet payment pages. First-time users can register at these pages.
User Fee Cover Sheets
Industry users who have received FDA invoices in the mail may click on the specific user fee program link directly below to access the FDA Account Management System to view account activities and pay the invoices online. Users require a user name and password to proceed once they get to the invoice payment pages. First-time users can register at these pages. Please note that the FDA Account Management System is currently not available for all user fee invoices. To pay invoices online for Export Certificate Fees and Civil Money Penalties (CMP), click on the user fee program link to access the payment portal. Export and CMP users do not require a login to access the payment portal. For additional information regarding payment methods for invoices for Mammography Inspection Fees and other user fee programs, please refer to FDA User Fee Payment Information.
User Fee Invoices
For questions, please contact the User Fee Help Desk at (301) 796-7200 or firstname.lastname@example.org.