§ 1.72 - Data elements that must be submitted in ACE for articles regulated by FDA.

§ 1.72 Data elements that must be submitted in ACE for articles regulated by FDA.

Cross Reference

Link to an amendment published at 87 FR 62984, Oct. 18, 2022.

General. When filing an entry in ACE, the ACE filer shall submit the following information for food contact substances, drugs, biological products, HCT/Ps, medical devices, veterinary devices, radiation-emitting electronic products, cosmetics, and tobacco products.

(a) Product identifying information for the article that is being imported or offered for import. This consists of:

(1) FDA Country of Production, which is the country where the article was last manufactured, processed, or grown (including harvested, or collected and readied for shipment to the United States). The FDA Country of Production for an article that has undergone any manufacturing or processing is the country where that activity occurred provided that the manufacturing or processing had more than a minor, negligible, or insignificant effect on the article.

(2) The Complete FDA Product Code, which must be consistent with the invoice description of the product.

(3) The Full Intended Use Code.

(b) Importer of record contact information, which is the telephone and email address of the importer of record.

[81 FR 85870, Nov. 29, 2016, as amended at 87 FR 62984, Oct. 18, 2022]