FDA to Allow for ACE Entries with 'Unknown' Data Elements
The Food and Drug Administration will allow filers to list "unknown" for some required data elements in ACE entries starting April 4, said CBP in a CSMS message (here). While currently listed as mandatory within the FDA's Supplemental Guidance, filers…
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will be able to file entries in ACE without information on intended use code, brand name, device listing number and active ingredient producer, said CBP. "If filers are unable to obtain this information at the time of transmission, a value of 'UNK' (unknown) will be allowed to assist in the transition from ACS to ACE," said CBP. Also, "entity role code 'GD' is temporarily not required for the Active Ingredient Producer" as of April 4, CBP said. Those four data elements will continue to be required and "failure to transmit the complete information, including a value of 'UNK', will result in CBP rejecting the entry," CBP said. "If the correct information or UNK is provided, FDA may request documentation and further information about the entry. FDA highly encourages filers to transmit complete data sets, including Intended Use, Brand Name, Device Listing Number, and Active Ingredient Producer, when required by the specific commodity. Filers that transmit complete information will receive priority review of entries and an expedited review process."