Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        FDA User Fee Programs

Export Certificate Fees Home
          For Industry
          FDA User Fee Programs
          Export Certificate FeesFDA User Fee Programs Export Certificate Fees
  	
        Share
    Post
    Linkedin

    Email
    PrintFirms 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 requestCDER

$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 requestCDRH

$175 for the first certificate
	$85 for any subsequent certificates issued for the same products(s) in response to the same request.CFSAN

$175 for the first certificate
	$155 for the second certificate for the same product(s) issued in response to the same request
	$100 for each subsequent certificate for the same product(s) issued in response to the same requestCVM

$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.For more information about the Export Certificate Program, please visit the FDA Export Certificates page.

                                                                                  Content current as of:
      01/30/2019
                  
                   
Topic(s)
			  User FeesExport Certificate Fees
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop