The Internal Revenue Service today released the final regulations on the Medical Device Tax which will go into effect in January of 2013 unless it is repealed between now and the end of the calendar year.
Industry groups from across the country have been actively working with both the IRS and with Congress to share with them the far reaching impacts that the tax will have on both new innovations and currrent products developed and/or manufactured on shore.
In a report earlier today, Damian Garde of Fierce Biotechg shared: that the agency is adopting very few of the suggested changes to the law’s major provisions.
“The final regulations do not adopt this suggestion.” That’s a phrase you get used to when reading the IRS’s 58-page document on the 2.3% tax. Commenters had asked for exceptions for devices with medical and non-medical uses, more specific definitions of “taxable medical devices” and provisions that would account for a device’s pricing before applying the tax, among other things.
All of these were weighed, debated and ultimately rejected by the IRS, which by and large affirmed its last guidance, something we covered in detail last month. In sum, that leaves a 2.3% tax on medical devices as defined by the FDA, with exemptions for devices that are sold directly to consumers, destined for further manufacture or slated to be sold outside the U.S. (Source: IRS pays little mind to industry feedback in final device tax regs – FierceMedicalDevices )
The new IRS regulations cover 58 pages. To download a copy, please click here: Medical Device Tax Final Rules 2012-29628_PI