North America
Keep an eye on next year’s over-the-counter drug user fee negotiations for insights into the incoming Republican administration's approach to device regulation, attorneys said in a recent webinar. Other areas to watch include AI and diagnostics regulation, with potential bipartisan agreement on AI oversight
The FDA’s final guidance on PCCPs for AI-driven devices highlights rapid advancements in health care AI, providing a roadmap for future progress. It emphasizes iterative improvements, version control, and maintaining device safety and effectiveness.
During an online seminar Tuesday, the FDA offered guidance on registration and listing requirements for lab-developed tests that will go into effect on 6 May 2026.
The agency also will not expand the guidance categories that may be issued “for immediate implementation” without prior public comment, but more guidance documents could be issued in Q&A or bulleted formats, the agency said.
A recent pilot program from public-private partnership MDIC attempted to apply the FDA’s established Voluntary Improvement Program framework to manufacturers with known compliance issues. Participants found an improved mindset, a better relationship with the FDA, and conclusions to ongoing enforcement actions.
A new FDA guidance addresses concerns about device shortages due to ethylene oxide (EtO) restrictions by allowing manufacturers of class III devices to switch sterilization sites before filing a PMA or HDE, helping to prevent supply chain disruptions and ensuring timely device sterilization.
Martin Makary’s ties to a compounder and telehealth company offering compounded GLP-1s may concern the drug industry and raise questions about his fundamental beliefs in the FDA’s role regulating drug manufacturing.
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).
This week, the US device center announced a pilot program to speed communications about high-risk recalls; Cardinal paid $3.9B for Advanced Diabetes Supply Group and GIA Alliance; a companion diagnostic for Merck lung cancer drug Tepmetko got FDA clearance; and more.
In its inaugural two-day meeting, the FDA Digital Health Advisory Committee discussed the promise of generative AI-enabled medical devices as well as challenges the agency faces in premarket evaluation, benefit/risk analysis, and postmarket monitoring.
Oz is widely seen as a gifted health communicator and has device-industry cred, but brings little experience running a large government organization or with the policy and budget challenges confronting Medicare and Medicaid.
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.
Medical device manufacturers are among the companies that will face more regulatory challenges in the coming year. Two new reports look at the growing complexity of the regulatory landscape organizations will have to navigate.
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.
Far-reaching AI regulations issued in the European Union also hold implications for US firms, a recent journal article claims. Companies that sell, use, import or distribute AI devices in the EU are all affected.
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.
Attorneys with law firm Gibson Dunn believe that fewer investors will be investigated for False Claims Act violations under the incoming Trump administration but expect other policy to go full steam ahead.
The US FDA has increased the number of devices cleared through its breakthrough program, which the agency established in 2015 to expedite access to products aimed at treating life-threatening and debilitating diseases.
