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 |
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Standard Turn-Around: 5 business days | Rush Turn-Around: 2 business days |
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❖ 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 |
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| Standard Turn-Around: 10 business days | Rush Turn-Around: 2 business days Additional Incomplete Data Fee: $245/filing | Additional Rush Fee: $125/filing |
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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 |
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❖ 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 ❖ FDA/CBP Identifier ❖ 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 ❖ FDA/CBP Identifier
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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 all inquiries, please contact us at newregistrations@fdaimports.com