Frequently Asked Questions

482. What key changes did the December 23, 2016 regulatory amendment to the Iranian Transactions and Sanctions Regulations (ITSR) make relating to the exportation and reexportation of agricultural commodities, medicine, and medical devices to Iran?

Answer

The amendment primarily expands the scope of medical devices that can be exported or reexported to Iran without specific authorization. It authorizes the exportation or reexportation to Iran of all items meeting the definition of the term “medical device” as defined in section 560.530(e)(3) of the ITSR, except for certain excluded persons as well as certain medical devices that are excluded from the authorization and published on the List of Medical Devices Requiring Specific Authorization. The exportation and reexportation of items on the List of Medical Devices Requiring Specific Authorization or to excluded persons requires a specific license from OFAC. The amendment also adds shrimp and shrimp eggs to the list of agricultural commodities that may be exported to Iran without specific authorization, other than to certain excluded persons.

In addition, the amendment authorizes covered persons to provide training, other than to certain excluded persons, necessary and ordinarily incident to the safe and effective use of agricultural commodities, medicine, and medical devices exported or reexported pursuant to section 560.530 of the ITSR. It also authorizes the importation into the United States of certain U.S.-origin agricultural commodities, medicine, and medical devices that were previously exported or reexported to Iran pursuant to the authorizations in section 560.530 of the ITSR and that are broken, defective, or non-operational, or are connected to product recalls, adverse events, or other safety concerns. Additionally, the amendment authorizes the exportation or reexportation to Iran, and storage within Iran for future use, of a limited number of replacement parts for certain medical devices previously exported or reexported to Iran pursuant to an OFAC license to replace broken or non-operational components or where it is ordinarily incident and necessary to proper preventative maintenance of the medical device, and the exportation or reexportation of software and services related to the operation, maintenance, and repair of medical devices.

Date Released
December 22, 2016