Legislation

The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.

The US FDA has finalized guidance on notifying the agency of potential device shortages during or prior to a public health emergency. The document includes a list of devices that manufacturers must notify the FDA of when they are in short supply. The guidance also clarifies that device makers voluntarily notify the agency of potential supply chain disruptions at any time.

The medtech industry played a pivotal role in the first Trump administration, most notably during the COVID-19 pandemic. But the sector was also impacted by the administration’s deregulation push and trade posture towards China, including tariffs. So, should stakeholders expect more of the same in a second Trump term, or brace for uncertainty and change?

A US House Oversight Committee report criticizes the government's COVID-19 response, including PPE shortages and issues with the CDC’s test development process. However, it praises the successful public-private partnerships in developing diagnostics, emphasizing the importance of leveraging private industry expertise for future pandemic preparedness.

Illumina's successful appeal to the European Court of Justice could transform life science transactions. However, the ruling has notable limitations and further jurisdictional stretch from the European Commission is expected, said Latham and Watkins lawyers at the Jefferies London Healthcare Conference.

The US Senate is considering a bill to expand Medicare coverage for breakthrough devices and diagnostics, removing the five-per-year limit imposed by CMS’ Transitional Coverage for Emerging Technology (TCET).

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.