Finalized Rule For FDA Entry Filing Requirements in ACE

Back in January 2016, we sent a newsletter about the mandatory transition of U.S Customs and Border Protection (CBP)  and Partner Government Agenies to ACE. Today, under the Federal Register, the Food And Drug Administration have finalized their rules.

The Food and Drug Administration (FDA ) has issued a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. This action will facilitate automated ‘‘May Proceed’’ determinations by FDA for low-risk FDA-regulated products which, in turn, will allow the Agency to focus on their limited resources on products that may be associated with a greater public health risk.

The Final Rule will take in effect on:  December 29, 2016.

The following data elements are required 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.

-Country of Production: 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 (Must be consistent with the invoice description of the product)

– Full intended use code (which may be UNK for “unknown”)

– Point of Contact of Importer of Record (Phone Number and E-mail address)

– Affirmation of Compliance for Product Specific Date Elements

Rejection of Entry Filing.
•Clarifies  that  FDA  may  reject  an  entry  filing  for  failure  to  provide  complete  and  accurate  information  as  required  in  the  final  rule; not included in the proposed rule.

Please read the final rule to make sure that you provide complete information to Flegenheimer International in order for us to process your entries.

Thank you,

Flegenheimer Team