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U.S. Department of Health and Human Services

For Industry

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Affirmation Of Compliance Code

One of the functions of the FDA - ACS Interface is the automated screening of FDA regulated import entries to determine which entries to "MAY PROCEED" without FDA examination and which entries require further "FDA REVIEW.”  An Affirmation of Compliance (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 the firm or product identified in a FDA line meets requirements specific to each code.  While submission of this information is voluntary, transmission of the data may expedite initial screening and further review of an entry. 

 

The following documents provide the most current AofCs available for use with FDA regulated products.  The "FDA Affirmation of Compliance (AofC) Code Reference Guide" provides a detailed explanation of each code and the proper qualifier syntax.  The  "FDA Affirmation of Compliance (AofC) Code Quick Reference" is a one page document designed to be a quick reference to determine which AofCs are applicable by commodity type and if a qualifier is required.

 

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Affirmation Of Compliance Quick Reference Guide

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Affirmation Of Compliance Reference Guide

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