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FDA Export Certification - Revised Guidance -US FDA

This guidance document is intended to provide a general description of FDA Export Certification to industry and foreign governments.

This guidance supersedes the document issued under this title in July 2004, as corrected in April 2005 and February 2019. This version of the guidance replaces the one made available in February 2019.

What is FDA Export Certification?

FDA export certification provides information concerning a product and/or establishment’s regulatory or marketing status, based on available information at the time FDA issues the certification (including, as appropriate, attestations provided by the person seeking the export certification).

A foreign government may also require export certification as part of the process to register or import a product into that country.

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and other statutes FDA administers.

This revision of the guidance includes changes to reflect existing FDA policies concerning the issuance of export certifications, including with respect to the issuance of certain export certifications for food for humans or animals pursuant to section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act.

Certificate of Free Sale, Certificate of a Pharmaceutical Product are a couple of examples of export certificates that FDA issues.


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