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FDA Offers Update on Affirmation of Compliance Codes for Regulated Goods

Wednesday, May 15, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has published two new documents to provide the import trade community with the most current affirmation of compliance codes available for use with FDA-regulated products. The “FDA Affirmation of Compliance Code Reference Guide” provides a detailed explanation of each code and the proper qualifier syntax. The “FDA Affirmation of Compliance Code Quick Reference” is a one-page document designed to help filers determine which codes are applicable by commodity type and if a qualifier is required.

One of the functions of the FDA-Automated Commercial System interface is the automated screening of FDA-regulated import entries to determine which may proceed without FDA examination and which require further FDA review. An AofC code, transmitted at the FDA line level, is one data element used in this screening process. By using an AofC code, the filer affirms that the firm or product identified in a FDA line meets requirements specific to each code. While submission of this information is voluntary, it may expedite initial screening and further review of an entry.

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