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U.S. Department of Health and Human Services

For Industry

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User Fees

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Resources for You

Export Certificate Fees

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a "certificate" for products regulated by the FDA.  A certificate is a document prepared by FDA containing information about a product's regulatory or marketing status. In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States or meet specific U.S. regulations. Review of an FDA Export Certificate may be a required part of the process to register or import a product into another country.

 

Section 801(e)(4)(B) of the Federal Food Drug and Cosmetic Act authorizes FDA to collect user fees for export certificates for human drugs, animal drugs and devices. The fees, authorized under the FDA Export Reform and Enhancement Act of 1996, allow the Food and Drug Administration (FDA) to partially recover its costs for personnel, equipment, supplies, printing and overhead. The legislation caps the fee at $175 per certificate.

 

CBER
  • $175 for the first certificate
  • $175 for the second certificate for the same product(s) issued in response to the same request
  • $85 for each subsequent certificate for the same product(s) issued in response to the same request
CVM
  • $175 for the first certificate;
  • $155 for the second certificate for the same products(s) issued in response to the same request;
  • $70 for each subsequent certificate for the same product(s) issued in response to the same request.
CDER
  • $175 for the first certificate
  • $90 for the second certificate with attachments for the same product(s) issued in response to the same request
  • $40 for any subsequent certificates with attachments for the same products(s) issued in response to the same request
CDRH
  • $175 for the first certificate
  • $15 for any subsequent certificates issued for the same products(s) in response to the same request.

 

 

For more information about the Export Certificate Program, please visit the Export Certificate Guidance page through "Resources For You."

 

 

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