On December 23, 2016, the Treasury Department’s Office of Foreign Assets Control (OFAC) issued a final rule amending the Iranian Transactions and Sanctions Regulations (ITSR) to expand the scope of permissible exports and reexports of medicine, medical devices and agricultural commodities to Iran and clarify the terms “Iranian origin” and “Iranian-origin goods.” The Final Rule significantly expands the scope of the general license for medical devices to Iran, authorizing manufacturers to export all medical devices satisfying the definition in the Federal Food, Drug, and Cosmetic Act (FFDCA) that are also designated EAR99 or would be if located in the United States with the exception of certain devices appearing on a special exclusion list.