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IRS Releases Final Regulations and Interim Guidance on Medical Device Excise Tax


On December 7, 2012, the U.S. Treasury Department published Final Regulations and additional interim guidance under Internal Revenue Code (“IRC”) section 4191 relating to the medical device excise tax (“MDET”) that was enacted as part of the Health Care and Education Reconciliation Act of 2010, in conjunction with the Patient Protection and Affordable Care Act. Effective January 1, 2013, IRC §4191 imposes a 2.3% excise tax on sales of certain medical devices by the manufacturer, producer, or importer of the device. The Final Regulations generally adopt the guidance in the proposed regulations issued on February 7, 2012, but provide greater certainty with respect to the types of devices that are subject to the MDET and clarification on the retail exemption and other exemptions.

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