All FDA-regulated products are expected to be in compliance at the time of entry. To help expedite FDA’s review of product compliance, the entry filer can submit additional information at the time of entry, such as registration, listing, and approval numbers. This information can be submitted by using Affirmation of Compliance codes (A of C codes).
By using an A of C code, the entry filer affirms that the firm and/or product identified in an FDA line meets the requirements specific to each code. Depending on the product you are importing, submission of certain A of C codes might be mandatory. The submission of voluntary A of C codes in addition to all mandatory A of C codes may expedite initial screening and further review of an entry.
The responsible party, such as the manufacturer or importer, should be able to indicate when these affirmations should be used and supply the qualifier when required.
What is an A of C qualifier?
Qualifiers provide product and manufacturer specific information. FDA uses this information to verify that the product is in compliance. Some affirmations require a product manufacturer’s registration number, unique to the facility, or a product’s approval number, specific to the product.
Where can I find a list of affirmation of compliance codes and qualifiers?
- The affirmation of compliance code quick reference guide provides an overview of A of C codes and will help you determine which code(s) to use with your product type.
- The ACE affirmations of compliance is a detailed document with each code, code description, qualifier description, and qualifier example.