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U.S. Food and Drug Administration
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  3. Guidance, Compliance & Regulatory Information (Biologics)
  4. Compliance Actions (Biologics)
  5. Exporting CBER-Regulated Products
  6. Description of FDA Forms for Export Certification
  1. Exporting CBER-Regulated Products

Description of FDA Forms for Export Certification

There are four FDA forms (Form FDA 3613, 3613a, 3613b, and 3613c) related to exporting FDA regulated products. A description of each form is provided below. To obtain a fillable PDF file of each form, visit our FDA Forms: Certificates for Export webpage. To learn more about how to complete these forms, visit our How to Complete FDA Forms for Export Certification webpage.

  • Supplementary Information - Certificate to Foreign Government (Form FDA 3613): This form is used for the export of products legally marketed in the United States. Certificate requests should include all information listed on this Form FDA 3613. Please ensure that the Exporter's Certification Statement is signed by a responsible official of the exporting firm and is enclosed with the certificate request.
    • If the product being exported is a human cells, tissues and cellular and tissue-based product (HCT/P) procured prior to May 25, 2005, please ensure the appropriate Exporter’s Certification Statement, “Certificate to Foreign Government” (For Human Tissue Intended for Transplantation) is signed by a responsible official of the exporting firm. Enclose this signed form with your certificate request to acknowledge compliance with all applicable requirements of FDA regulation, Title 21, Code of Federal Regulations Part 1270.
    • If the product being exported is a HCT/P procured after May 25, 2005, please ensure the appropriate Exporter’s Certification Statement, “Certificate to Foreign Government” (Human Cells, Tissues and Cellular and Tissue-Based Products) is signed by a responsible official of the exporting firm. Enclose this signed form with your certificate request to acknowledge compliance with all applicable requirements of FDA regulation, Title 21, Code of Federal Regulations Part 1271.
  • Supplementary Information - Certificate of Exportability (Form FDA 3613a): This form is used for the export of products not approved for marketing in the United States (unapproved products) that meet the requirements of Sections 801(e) or 802 of the Act. Certificate requests should include all information listed on this Form 3613a. Please ensure that the Exporter's Certification Statement is signed by a responsible official of the exporting firm and is enclosed with the certificate request.
  • Supplementary Information - Certificate of a Pharmaceutical Product (Form FDA 3613b): This form conforms to the format established by the World Health Organization (WHO) and is intended for use by the importing country when the product in question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending or reviewing a license. WHO Certificate requests should include include all information listed on Form FDA 3613b. Please ensure that the Exporter's Certification Statement is signed by a responsible official of the exporting firm and is enclosed with the certificate request.
  • Supplementary Information - Non-clinical Research Use Only Certificate (Form FDA 3613c): This form is used for the export of a non-clinical research use only product, material, or component that is not intended for human use which may be marketed in, and legally exported from the United States under the Federal, Food, Drug and Cosmetic Act. Certificate requests should include all information listed on Form FDA 3613c. Please ensure that the Exporter's Certification Statement is signed by a responsible official of the exporting firm and is enclosed with the certificate request.

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