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FDA Export Certification Guidance for Industry August 2021

Final Level 2 Revised Guidance
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine

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.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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