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          FDA Export CertificationSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	FDA Export Certification
					Guidance for Industry
		
		August 2021


	Download the  Final Guidance Document 

    Final
		
		    		Level 2 Revised Guidance

	  
	  
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		    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.

                                                                                  Content current as of:
      08/20/2021
         
                  
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