Issue Date: August 20, 2021
Issued by: Center for Biologics Evaluation and Research
Topic(s): Export, Import
Status: Final
FDA Export Certification: Guidance for Industry
This guidance document is intended to provide a general description of Food and Drug Administration (FDA or the Agency) export certification to industry and foreign governments. 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 guidance supersedes the document issued under this title in July 2004, as corrected in April 2005 and February 2019.
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