Major news for medical devices sold in America over the next two years: Excise tax will remain un-imposed. This refers to a 2.3% tax enacted in 2010 to offset Affordable Care Act costs. Delayed a first time in 2015, this second delay saves medical device companies an estimated $3.75 billion between now and January 1, 2020, fostering innovation and protecting consumers from increased insurance expenditures. Right on time, too, as taxes were to resume imminently. STAT correspondent Erin Mershon talks about this here.
Give a man a gun, and he is lethal to a one-mile radius. Teach him to engineer an indomitable virus, and he can demolish entire populations without ever blowing his cover.
That’s the old adage, right?
The European Commission decided that cranberry products are not medical devices, according to a recent article published by Regulatory Affairs Professional Society. While this seems to state the obvious, products containing cranberry or cranberry extract are sometimes marketed as medical devices across the EU. Their mechanism of action involves proanthocyanidins (PAC), a class of polyphenols known to prevent and treat urinary tract infections. The committee’s decision applies to products that rely primarily on PAC to accomplish intended outcomes and will likely come into effect later this summer.