Reuters reports that U.S. Rep. Earl Blumenauer (D-OR) issued a letter to the FDA questioning its inspection practices related to Neuralink. The report said Blumenauer asked why the FDA decided not to investigate the Elon Musk-backed brain chip maker before allowing in-human trials. This relates to repeated questions around animal practices at the company. Reuters […]
U.S. Congress
Congressional leaders want more info on COVID supply chain
Leaders in both houses of Congress want federal trade officials to further investigate the supply chain for COVID-19-related goods and devices, but don’t expect any answers before December. Members of the House Ways and Means and Senate Finance committees wrote a letter to U.S. International Trade Commission (USITC) chairman Jason Kearns last week, asking for a more […]
House members introduce companion medical device tax repeal bill
A quartet of U.S. representatives today introduced a companion bill to a Senate measure that would do away with the medical device tax altogether. The 2.3% levy on U.S. medical device sales went into effect in 2013 but was only in place for two years before Congress put a moratorium in place. When that ended […]
Medtech reporting would change under new opioid law
A section of the recently-passed bill to address the opioid crisis could have implications for medtech. The 250-page Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patients and Communities Act) contains a provision that would require manufacturers of certain medical devices, drugs and biologics covered by Medicare, Medicaid, […]
IRS won’t enforce penalties on medical device tax
The U.S. Internal Revenue Service yesterday said it won’t enforce penalties on companies making late payments on the medical device tax for the first three months of this year. The 2.3% excise tax on U.S. medical device revenues was in effect for two years before a two-year moratorium went into effect for 2016 and 2017. It went […]
Medical device tax: Shutdown-averting stopgap would delay tax, Senate bill would kill it outright
House Republicans last night presented their plan for funding the government ahead of an end-of-week shutdown deadline that would press the pause button again on the medical device tax, but it’s unclear whether the fractious GOP can unite in the face of Democrats’ opposition. The 2.3% excise tax on U.S. medical device revenues was in […]
Mass. Dems file Senate medical device tax repeal bill
The Massachusetts Senate delegation this week became the latest politicians to file a bill that would repeal the medical device tax enacted as part of the Affordable Care Act. The 2.3% excise tax on U.S. medical device revenues was in effect for two years before a two-year moratorium went into effect for 2016 and 2017. […]
The medical device tax is back in effect
The ringing in of the new year also rang in the return of the medical device tax, a 2.3% levy on medtech sales that went back into effect after a two-year pause. The U.S. Congress closed out 2017 without taking action to delay or repeal the medtech tax, despite broad support from both sides of the […]
Health advocates pan research funding bills that would streamline FDA approvals
Measures in the U.S. Congress that would link research funding to moves designed to simplify the approval process for medical devices and drugs is reportedly drawing flak from public health advocates, including a former FDA commissioner. Last July, the U.S. House of Representatives passed the 21st Century Cures Act, a sweeping bill to speed new […]
Congress targets FDA’s pre-market reviews, clinical trials for medical devices
By Stewart Eisenhart, Emergo Group Legislation advancing through both houses of the U.S. Congress would require “least burdensome” training of FDA staff involved in pre-market reviews of medical devices. Originally introduced in the Senate last year, the FDA Device Accountability Act of 2015 would impact US regulators’ premarket review process as well as requirements for Institutional […]
Senate health panel mulls medical device tax
A U.S. Senate subcommittee today held a hearing on the medical device tax featuring testimony about its deleterious effects from industry and patient advocates.
