Effective December 23, the Department of the Treasury's Office of Foreign Assets Control (OFAC) amended the Iranian Transactions and Sanctions Regulations (ITSR) to expand the scope of medical devices that can be exported to Iran.
Now, unless specifically excluded by ITSR section 530(a)(3)(ii)-(iv), an item that qualifies as a "device" under section 201 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 321) and is designated EAR99 (or would be if it were located in the United States) can be exported or re-exported to Iran without specific authorization from OFAC. (Previous restrictions on payment terms and shipping dates remain in effect.)
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