Visit our Affirmation of Compliance Codes page for more information.
TEAMSID EXPORT RECORDS CODE
The code indicates to FDA that the product in some way does not comply with FDA laws and regulations, is intended to be further processed while in the US, and will be exported. When an IFE entry is submitted in the ABI system, the customs broker (entry filer) should use the FDA affirmation of compliance code “IFE”. In order to maintain the bond in place for Consumption or Warehouse entry types, FDA will maintain detention of the entry until the product is exported.įor TIB entries, FDA will release the entry because a good and sufficient bond remains in place with Customs and Border Protection (CBP), even if FDA releases the entry.īack to top What information should I submit to FDA for IFE entries? For more information on these entry types, please visit the common entry types web page. Informal entries do not require a bond therefore IFE entries cannot be made under an informal entry. IFE entries are required to have a “good and sufficient bond” in place. The most common entry types used for IFE entries are Consumption entries and Temporary Importation under Bond (TIB) entries. IFE only applies to the products listed in the section above.īack to top What type of entry should be used for IFE? No, IFE cannot be used for finished food products that need to be relabeled. Find more information about Importing CBER-Regulated products into the United States.īack to top Can import for export be used for a finished food product that is to be relabeled? FDA laws and regulations allow for the importation of these blood products and components provided they comply with section 351(a) of the Public Health Service Act (PHSA), or if FDA permits such imports “under appropriate circumstances and conditions” as determined by the Center for Biologics Evaluation and Research (CBER). Medical devices, medical device components, accessories of a device, or other parts of a device requiring further processing, which are ready or suitable for use for health-related purposesīack to top Do blood, blood components, plasma, and source leukocytes qualify for import for export?īlood, blood components, plasma, and source leukocytes have IFE requirements that differ from those for drugs and other biological products.What is the timeframe for holding IFE products?īack to top What products qualify for import for export?.What records should be kept for IFE entries?.What does it mean to be further processed and/or incorporated?.What information is required when the initial owner or consignee is not the importer?.What information should I submit to FDA for IFE entries?.What type of entry should be used for IFE?.Can import for export be used for a finished food product that is to be relabeled?.Do blood, blood components, plasma, and source leukocytes qualify for import for export?.What products qualify for import for export?.Products imported under the IFE provision may not be distributed or sold in the U.S. In order to qualify for this exemption from refusal, at the time the products are offered for import you must provide FDA with certain information regarding your intention to further process the product. for further processing and ultimately exported out of the U.S. IFE allows for the importation of a product that is unapproved or otherwise does not comply with FDA laws and regulations if it is coming into the U.S. It includes important information you will need to know in order to utilize the Import for Export (IFE) provisions. This page provides an overview of the import for export (IFE) provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) section 801(d)(3).
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