| Title: | FDA announces New Affirmation of Compliance (AofC) Reference Guides |
|---|---|
| Date: | 2013-05-14 |
| To: | abi |
| Links: | previous, original, next |
The FDA published two new documents to provide the import trade community with the most current Affirmation of Compliance (AofC) codes 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 codes are applicable by commodity type and if a qualifier is required.
These documents are found at the following link: http://www.fda.gov/ForIndustry/ImportProgram/ucm349871.htm
Use of these codes affirms that the product identified in an FDA line meets the requirements specific to the code. While use of the codes is voluntary, transmission of the data may expedite initial screening and further review of an entry.
If you have any questions, please contact: FDAImportsInquiry@fda.hhs.gov