There are two types of FDA Registration Renewal: Annual and Biennial.
A DUNS Number is required for annual and biennial registrations.
The FDA recognizes the DUNS Number as the only acceptable Unique Facility Identifier (UFI) for the purpose of registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.
FDA Registration Number or renewal, will be denied to companies without a DUNS Number.
- OTC Drugs Establishment Registration
- Prescription Drugs Establishment Registration
- Medical Devices Establishment Registration
- Cosmetics Establishment Registration
Current annual registration renewal is before December 31, 2023.
- Food Facility Registration
- Supplements Facility Registration
- Food Canning Establishment (FCE) Registration
However, the biennial registration renewal is required between October 1, 2024 and December 31, 2024.
With the exception of food facilities, the registration renewals require the payment of User Fees to the U.S. Treasury.
Examples of User Fees are:
$6,493.00 annual for medical establishment registration.
Over-the-Counter (OTC) Establishments
- Monograph Drug Facility (MDF) Facility Fee: $24,178
- Contract Manufacturing Organization (CMO) Facility Fee: $16,119
Click here for a complete list of User Fees.
If you ship regulated products to the United States without renewing your company’s registration, the cargo will be detained by the U.S. Customs and the FDA. Therefore, make sure your registration is current, and not expired.
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