ACE Entry Filing Requirements for FDA-Regulated Goods Finalized
The Food and Drug Administration has issued a final rule that, effective Dec. 29, will require certain data elements material to admissibility reviews on imported FDA-regulated products to be submitted in the Automated Commercial Environment (or any other electronic data interchange system authorized by U.S. Customs and Border Protection) at the time of entry.
The FDA states that this rule will facilitate automated “may proceed” determinations for low-risk FDA-regulated products and thus allow the agency to focus its limited resources on those products that may be associated with a greater public health risk. To that end, the FDA may reject any entry filing that does not contain the complete and accurate information required by this rule without performing an admissibility review.
The final rule requires the following data elements to be submitted in ACE at the time of entry for food (as applicable), drugs, biological products, human cells, tissues, and cellular and tissue-based products, medical devices, radiation-emitting electronic products, cosmetics, and tobacco products.
- the country where the article last underwent any manufacturing or processing of more than a minor, negligible, or insignificant nature or where the article was grown (including harvested or collected and readied for shipment to the U.S.)
- complete FDA product code, which must be consistent with the invoice description of the product
- full intended use code (which may be UNK for “unknown”)
- email and phone number of the importer of record
- product-specific data elements
The final rule does not require submission of the following data elements that were included in the proposed rule: FDA value and quantity, contact information for persons related to the importation other than the IOR (e.g., manufacturer, shipper, importer of record, or “deliver to” party), name and address of the ACE filer for tobacco products, the investigational new drug application number for device-drug combination products, and the drug listing number for human drugs regulated by the FDA’s Center for Biologics Evaluation and Research.
This rule also makes technical revisions to certain sections of the FDA’s regulations to make updates and provide clarifications. These include updating the definition of “owner” or “consignee” to make it consistent with title 19 of the U.S. Code, allowing the FDA to provide notice of sampling directly to an owner or consignee, and clarifying that written notice can be provided electronically to owners or consignees of FDA actions to refuse and/or subject certain products to administrative destruction.