On December 23, 2016, the Office of Foreign Assets Control (OFAC) published in the Federal Register a final rule amending the Iranian Transactions and Sanctions Regulations (ITSR) to reflect OFAC’s licensing policies and address inquiries from the regulated public. This final rule makes changes relating to authorized sales of agricultural commodities, medicine, and medical devices to Iran pursuant to the Trade Sanctions Reform and Export Enhancement Act of 2000 (TSRA), as amended, and clarifies the definition of the terms goods of Iranian origin and Iranian-origin goods.

The final rule amends the licensing provisions of the ITSR to expand the scope of medical devices and agricultural commodities generally authorized for export or reexport to Iran and, in response to feedback from the regulated public regarding improving patient safety, provide new or expanded authorizations relating to training, replacement parts, software and services related to the operation, maintenance, and repair of medical devices, and items that are broken or connected to product recalls or other safety concerns.