Here is a copy of the letter from Rob Kerwin, General Councel for IAMERS, to Kara Getz, Esq., Tax Counsel to the Hon. Richard E. Neal, U.S. House of Representatives, regarding the January 2013 Medical Device Excise Tax. It is our priority to get clarification from the Department of Treasury on whether or not the excise tax applies to pre-owned medical equipment. We have requested a conference call with them to clarify this matter.
We will keep you posted on the progress.
For an additional perspective, albeit incomplete, please visit; http://www.grantthornton.com/staticfiles/GTCom/Tax/TF_TLU_TPU%20files/Tax_Insights_2012-14_final_MDET_regulations.pdf .
Will devices built during design and development stage used by the manufacturer for testing design and efficacy prior to the application for and receipt of product clearance for human use under 510(k) be exempt from the excise tax until commercially avilable for human use?
I believe they will be exempt.