Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an export "certificate" for products regulated by U.S. FDA. An Export Certificate is a document prepared by U.S. FDA containing information about a product's regulatory or marketing status.
U.S. FDA currently offers the following types of Export Certificates:
"Certificates
of Free Sale"
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These export certificates are used for food, beverages, dietary supplements, and cosmetic products that may be legally marketed in the United States.
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"Health Certificates
for Food/Feed"
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These export certificates are usually consignment-specific and relay the equivalence U.S. compliance to the foreign government's regulations.
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"Specified Risk Materials of Bovine, Ovine and Caprine Origin Certificate"
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These export certificates are used for gelatin that may be legally marketed in the United States.
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"Certificate of a Pharmaceutical Product"
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These export certificates are used to confirm the pharmaceutical product conforms to the standards set by the World Health Organization (WHO).
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"Non-clinical Research Use Only Certificate"
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These export certificates are used for a product that is not intended for human use but which may be marketed for non-clinical research use only.
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"Certificate to Foreign Government"
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These export certificates are used for human drugs, biologic products, animal drugs, and medical devices that may be legally marketed in the United States.
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"Certificate of Exportability"
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These export certificates are for human drugs, biologic products, animal drugs, and medical devices that cannot be legally marketed in the United States but which may be legally exported.
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