FDA Export Certification

On 20 August 2021 the FDA published the final guidance for industry.

This guidance document is intended to provide a general description of FDA 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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