| Title: | FDA ACE Supplemental Guide v. 2.5 IUC Clarification |
|---|---|
| Date: | 2017-01-24 |
| To: | abi,air,ocean,rail,truck |
| Links: | previous, original, next |
This CSMS is being issued to provide clarification regarding the transmission of “UNK” (unknown) in place of the required Intended Use Code (IUC) in the FDA PGA dataset. As indicated in CSMS # 17-000017, the letters UNK can be transmitted for all commodities in place of an IUC. UNK should only be used in cases where there is no applicable IUC. The next version of FDA's Supplemental Guide will include this clarification.
FDA highly encourages filers to transmit complete data sets, including the correct Intended Use code. Failure to transmit complete and accurate information, including a valid IUC, may result in FDA requesting documentation and/or additional information about the FDA regulated product.
Please refer to PG01 in each commodity section of FDA's Supplemental Guide for the IUC's valid for that commodity.
Please direct any technical questions to ACE_Support@fda.hhs.gov.