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 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