Legislation
At a recent Washington, DC conference, key government figures expressed optimism that bipartisan efforts will continue to drive advancements in medical technology, even amidst political challenges. They also emphasized the importance of supporting ARPA-H and BARDA initiatives.
Robert F. Kennedy Jr.'s nomination to lead the US Department of Health and Human Services has generated both cautious optimism and concerns in the medtech sector, with concerns including a less science-based regulatory environment and potential user fee cuts.
Donald Trump’s victory in the US presidential election once again is creating a potentially unsettling transition process for the FDA. While it is far from clear that the new administration actually will want to disrupt the agency, there are several ways it could happen.
France’s medtech sector is strong, growing and innovative. Medtech Insight spoke to several French medtech leaders about the unique features and pitfalls their industry may face.
Republican presidential candidate Donald Trump says he will let Robert F. Kennedy Jr. “go wild on medicines” if he wins the White House. That could spell challenges for the US FDA in 2025.
The European Parliament is making a formal appeal to the European Commission to accelerate its EU MDR revision plans.
The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.
Highlights from Medtech Insight's on-the-ground coverage of LSX in Boston.
In a letter to US lawmakers, the Association for Diagnostics and Laboratory Medicine says the FDA’s final rule regulating lab-developed tests will stifle innovation and that Congress needs to step in and stop it.
With the reversal of the Chevron doctrine in June, lower courts will now have more say in deciding regulatory statutes when the language is murky. But will that open the door to more legal challenges from the healthcare industry against government regulations it finds unfavorable? A pair of legal experts recently discussed the potential implications of the Court’s decision.
California’s Toxic-Free Medical Devices Act to prohibit use of di-2-ethylhexyl phthalate in IV bags and tubing, now headed to Gov. Gavin Newsom’s desk, has broad support from lawmakers and a lack of opposition from industry at this stage. Pennsylvania is considering a similar bill, but with differences that could portend a patchwork legislation problem ahead in the US.
Multi-cancer diagnostics can help get oncology patients the treatment they need more quickly, but lack of reimbursement has kept such tests out of reach for many patients. Bills providing coverage have passed or are under consideration in more than half of the states and have been introduced in both houses of US Congress.
A government report requested by US lawmakers Debbie Dingell and Anna Eshoo to review the FDA’s postmarket surveillance of medical devices stresses that strengthening the system is critical to addressing adverse events linked to devices after they hit the market.
A bipartisan bill now in the US Senate seeks to change the classification of implantable hearing aid devices to allow Medicare to reimburse for the devices, potentially expanding access for many Americans who require them.
While the National Electrical Manufacturers Association supports the Biden Administration’s plan to impose tariffs on a range of Chinese goods coming into the US, it also supports holding off on their implantation.
In June, the US Supreme Court reversed the Chevron doctrine, a long-standing precedent requiring courts to defer to regulatory agencies when statutory language was ambiguous. But will that decision prevent the FDA’s final rule on laboratory developed tests from taking effect? A legal expert weighs in.
The US FDA has created a web page with answers to common questions concerning the agency’s final rule on regulating laboratory developed tests as medical devices.
A fiscal 2025 report from the US House Appropriations Committee instructs the FDA to halt implementation of its overhaul of LDT regulation. Members also showed concern about overseas device manufacturing and the availability of over-the-counter diagnostics.
The House Appropriations Agriculture, Rural Development, and FDA Subcommittee advanced the FDA’s fiscal year 2025 funding bill, beginning a likely long and difficult budget cycle.
Old habits die hard when it comes to funding the FDA. When the agency is doing things well, it doesn’t get the money it needs to keep up the momentum.