Fee Schedule

Please keep in mind before registering that all types of facilities, except for device facilities, are required by the FDA first to obtain a DUNS number; you can do this for free from Dun & Bradstreet; here is the link.

Registration, Listing & U.S. Agency Fee Schedule[1]

Conventional Foods

Dietary Supplements

Standard Turn-Around: 5 business days | Rush Turn-Around: 2 business days
Additional Incomplete Data Fee: $45/filing | Additional Rush Fee: $125/filing
Expired Submission Fee: $50

❖   Initial Registration                      $145

❖   Renew Registration                     $145

❖   Modify Registration                     $99

❖   U.S. Agency[2]                              $495

❖ FDA/CBP Identifier Validation   $395

❖ UFI Validation Assistance             $99

❖   Initial Registration                      $195

❖   Renew Registration                     $145

❖   Modify Registration                     $99

❖   U.S. Agency[2]                              $495

❖ FDA/CBP Identifier Validation   $395

❖ UFI Validation Assistance            $99

Cosmetics

Standard Turn-Around: 10 business days | Rush Turn-Around: 2 business days
Additional Incomplete Data Fee: $245/filing | Additional Rush Fee: $125/filing
❖   Initial Registration
❖   Renew Registration
❖   Modify Registration
❖   U.S. Agency[2]
❖   Product Listing
$595
$495
$99
$495
$245

Drugs

Medical Devices

Standard Turn-Around: 10 business days | Rush Turn-Around: 2 business days
Additional Incomplete Data Fee: $245/filing | Additional Rush Fee: $125/filing
Expired Submission Fee: $50

❖   Initial Registration                                        $695

❖   Renew Registration                                       $495

❖   Modify Registration                                       $99

❖   U.S. Agency[2]                                                $495

❖   NDC Labeler Code Request[3]                     $125

❖   API Drug Listing                                             $345

❖   OTC Drug Listing                                            $445

❖   Homeopathic Drug Listing                           $545

❖   Rx Drug Listing [4]                                      As quoted

❖   Kit Drug Listing                                               $745

❖   Product Listing Update                                  $125

❖   Product Listing Review & Affirmation[4]  $125

❖  Compounding Facility
     Semiannual Product Report                            $395

❖ FDA/CBP Identifier
     Validation                                                            $595

❖ Annual Drug Production Report [5]                $150

❖   Initial Registration             $695

❖   Renew Registration            $395

❖   Modify Registration            $99

❖   U.S. Agency[2]                     $495

❖   Device Product Listing       $395

❖   Device Kit Listing                $645

❖  Medical Device Product
      Listing Modification             $125  

❖ FDA/CBP Identifier
     Validation                                $595                       

 

 

Certificates of Establishment Registrations and/or Product Listings may be provided electronically for $125 per Certificate and can be renewed with your registration, annually or biennially.

 

[1] Rates effective as of August 30, 2023.

[2] The U.S. Agent fee of $495 per facility per year is billed annually, and payment is due by September 30. Pro-rated fees are not available. Failure to pay the U.S. Agent fee can result in the cancellation of the firm’s registration.

[3] NDC Labeler Code Request Turn Around Time will add an additional 10-15 business days to our standard turn around times for FDA processing

[4] Rates may vary. Please contact us for a quote. 

[5] Includes reporting for up to 10 unique NDC codes. Contact us for a quote if you have more codes. 

We provide registration, listing, and US agency services for food and beverage, dietary supplement, cosmetic, drug, and device products. For low-cost food facility registration, please go to our convenient Electronic Registration App Page. For all other inquiries, please contact us at newregistrations@fdaimports.com

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