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FDA Registration Fees

FDA Foreign Supplier Verification Program FSVP & Produce Safety fee 2024

  • Initial Assessment for your FSVP Compliance Date, Free
  • Initial Assessment for FSVP Exclusion Checkup, Free
  • FSVP Agent Representative Fee, 395 USD to 795 USD
  • FSVP Compliance Plan Development, Contact Us
  • Annual FSVP Review and Documentation, Contact Us
  • Standards of Produce Safety Compliance Assistance, Contact Us 

 

USDA Veterinary Science Import permits fee 2024

  

  • Initial USDA Permit Product Evaluations, Free
  • USDA Permit Filling Preparation and Submission , 395 USD
  • Technical Support & USDA Account, Free

U.S. FDA Color Additive Requirements fee 2024

  

  • Color Additive Initial Review, Free
  • FDA Batch Certification Assistance, 295 USD
  • FDA Account Registration, Free

U.S. FDA Food, Beverage and Dietary Supplement Labeling Requirements fee 2024

 

Service & Fees:

  • Current Label's Review & Assessment, Free
  • FDA Compliant Complete Labeling Service, 545 USD
  • Sixty Days Label Modifications, Free

 

Food Canning Establishment Registration FCE Submission Identifier SID Filling fee 2024

  

  • FCE Registration & SID filing (each product category) 795 USD
  • Additional Process Filing, (per SID) 195 USD
  • Technical Support & SID Renewal, Free
  • Registration Verification, Free

U.S. FDA Food Facility Registration for Food Beverage and Dietary Supplements fee 2024

 

Service & Fees:

  • Food Facility Registration, 395 USD
  •  U.S. Agent Representation, Free
  •  Food Facility Renewal, 295 USD
  •  Certificate of FDA Registration, Free
  •  ​Registration Verifications, Free

 

FDA Color Additive Requirements fee 2024

 

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  • Color Additive Initial Assessment , Free
  • FDA Batch Certification Submission Assistance, 295 USD
  • FDA Account Registration, Free

FDA 510k Preparations and Submissions fee 2024

  

  • Review of the Device Classifications and Device Labeling
  • Preparations of FDA 510(k) formats, and required elements
  • Submission of FDA 510(k), 10,000-14,000 USD
  • FDA fee payment on Your Behalf, Free
  • Communications with FDA, Free

FDA Medical Device Labeling Requirements fee 2024

 

  • Current Label's Review & Assessment, Free
  • FDA Compliant Complete Labeling Service, 995 USD
  • FDA Compliant New Label Content, Free
  • Sixty Days Label Reviews and Modifications, Free

U.S. FDA Global Device Identification GUDID Unique Device Identifiers UDI fee 2024

   

  • Assessment Determining if UDI/ GUDID submission Needed, Free
  • GUDID Account, 395 USD
  •  First UDI Submision 395 USD
  • Each additional UDI 195 USD
  • GUDID Verification and Interim Updates, Free

 

U.S. FDA Medical Devices Registration and FDA Device Listing fee 2024

  

  • Initial Assessment Determining if FDA Registration Necessary, Free
  • Registration of Device Establishment, 545 USD
  • Annual FDA fee payment on your behalf, Free
  •   Listing of Medical Devices, 95 USD/ 4 Device Class
  • Act as Official Correspondent (U.S. Agent) to FDA, Free
  • Certificate of FDA Registration and Device Listing, Free
  • Registration Verification and Interim Updates, Free

 

FDA Cosmetic Color Additives Batch Certification fee 2024

  

  • Color Additive FDA Requirement Initial Assessment , Free
  • FDA Batch Certification Submission Assistance, 295 USD
  • FDA Account Registration, Free

California Safe Cosmetics Program CSCP fee 2024

  

  • California's Safe Cosmetics Program Initial Ingredient Assessment, Free
  • California's Safe Cosmetics Program Reporting (CSCP), 295 USD
  • Certificate of California's Safe Cosmetics Program, Free
  • Registration Verification and Interim updates, Free

FDA Cosmetic Labeling Requirements fee 2024

 

 

  • Current Label's Review & Assessment, Free
  • FDA Compliant Complete Labeling Service, 645 USD
  • FDA Compliant New Label Content, Free
  • Sixty Days Label reviews and Modifications, Free

FDA Cosmetic Facility Registration and Product Listing- MoCRA fee 2024

 

Service & Fees:  

  •  Cosmetic Facility Registration, 495 USD
  • Cosmetic Product Listing, 395 USD
  • U.S. Agent Service, Free
  • FDA Registration Certificate, Free

 

FDA Drug Color Additives Requirement fee 2024

  

  • Color Additive FDA Requirement Initial Assessment , Free
  • FDA Batch Certification Submission Assistance, 295 USD
  • FDA Account Registration, Free

 

FDA Drug Establishment Registration and FDA Drug Listing fee 2024

  

  • Registration of Drug Establishment, 595 USD
  • Initial Assessment of Drug Classification, Free
  • Listing of Drugs (up to 4 package sizes), 495 USD
  • Act as Official Correspondent (U.S. Agent) to FDA, Free
  • Certificate of FDA Registration, Free
  • ​Certificate of Drug Listing (NDC), 195 USD
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FDA National Drug Code NDC Labeler Code fee 2024

  

  • Initial Assessment for FDA Requirements, Free
  • Preparation and Submission of SPL for NDC Labeler Code 395 USD
  • Acting as FDA US Agent, Free
  • NDC Resubmissions, Free

 

FDA Drug Labeling and Ingredient Requirement fee 2024

  Service & Fees: 

  • Current Label's Review & Assessment, Free
  • FDA Compliant Labeling Review, 745 USD
  • FDA Compliant New Label Content, Free
  •    Sixty Days Label reviews and Modifications, Free

 

FDA OTC Drug Establishment Registration and OTC Drug Listing fee 2024

 Service & Fees: 

  • OTC Drug Establishment Registration, 495 USD
  •  Labeler Code Application 395 USD 
  • Listing of OTC Drug 495 USD 
  • Act as Official Correspondent (U.S. Agent) to FDA, Free
  • Certificate of FDA EStablishment Registration, Free

 
FDAListing.com Inc., referred as FDA Listing Inc., is a privately held regulatory assistance company with headquarters in New York, USA. FDA Listing Inc. has no affiliation with or endorsement by United States Food and Drug Administration. The certificates issued by FDA Listing Inc. are only for the sake of confirmation of FDA registration for your industry partners and are not recognized by United States Food and Drug Administration - FDA.
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U.S. FDA Registration and Listing Inc

82 Nassau St, New York,
NY 10038, USA
Phone: +1 929-376-7870
Email: info