The Advanced Medical Technology Association (Advamed) said a bipartisan group of seven members of the U.S. House of Representatives has issued a "Dear Colleague" letter to foster co-sponsorship of a bill that would repeal the 2.3 percent tax on medical devices. The letter says that the tax will resume in January 2020, and that short-term suspensions of the tax do little to alleviate the threat of the tax, thus limiting the ability of makers of devices and diagnostics to make long-term investments necessary to bring novel products to market. Scott Whitaker, president and CEO of Advamed, said, "we simply can't allow this onerous tax to go back into effect at the end of the year," adding, "let's repeal it once and for all."
The U.S. FDA reported an emergency use authorization (EUA) for an in vitro diagnostic for Zaire ebolavirus by Chembio Diagnostic Systems Inc., of Medford, N.Y., effective Nov. 9, 2018. The agency said the terms of the EUA for the company's DPP Ebola antigen system include that it is not used for general screening for the Ebola virus.