390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
FDA Fees

When you contact ITB HOLDINGS LLC and request any of its several services, an invoice will be sent. Most fees are annual.

Some registrations require additional fees paid directly to the U.S. Government at the time of the registration, then between October 1 and December 31, every year for the following:

■ Medical Device Establishment
■ Drug Establishment

Animal Drug User Fee
Animal Generic Drug User Fee
Biosimilar User Fee
FSMA Reinspection and Recall User Fees
Device Facility User Fee (DFUF)
Generic Drug User Fee Amendments (GDUFA)
Medical Device User Fee Amendments (MDUFA)
Prescription Drug User Fee Act (PDUFA)

FDA has partnered with the U.S. Department of the Treasury to utilize a Web-based payment application, for online secure electronic payment. It takes 2-3 business days to process online payments and 7-10 business days to process wire transfers and check payments, then for your Payment Confirmation Number (PCN) to be assigned.

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. companies only.

While User Fees are expected to increase on October 1, 2020, ITB HOLDINGS LLC’s fees will remain the same, and the lowest.

So, why pay more for less? Perhaps, this is your chance to switch U.S. Agent.

All Food Facilities must renew their registrations between October 1 and December 31, 2020. You can simply prepay now to avoid competing with 500,000 companies before the end of 2020.

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