The European Union’s struggles with regulations for devices and in vitro diagnostics seem virtually endless, but the European Commission floated a series of changes that would present a significant reset of both regulations. One of the more sweeping changes would be to exempt medical technologies from much of the text of the Artificial Intelligence Act, a move that would ease the drag on AI-based technologies in the EU.

Much has been made of the recent skyrocketing of Medicare spending on skin substitutes, but a new enforcement action by the U.S. Department of Justice might help to explain some of those spending increases.

Edwards Lifesciences Corp., of Irvine, Calif., petitioned the Centers for Medicare & Medicaid Services to revise the Medicare coverage policy for transcatheter aortic valve replacement (TAVR) devices on two points, the combination of which would make a big difference for TAVR devices across manufacturers. Edwards requested that CMS explicitly cover TAVR for asymptomatic aortic stenosis patients, a notion well supported by recent data, and bring an end to the coverage with evidence development mandate.

The U.S. FDA announced Dec. 15 that it will take a more relaxed approach to device premarket applications using real-world evidence from data sources that lack individual patient-level data, a switch that might ease manufacturers’ efforts to expand a device’s labeled indication for use.

The U.S. FDA’s remote regulatory assessment (RRA) program, the subject of a guidance the agency finalized in June 2025, is proving to be one of the trickier bits of navigation for makers of devices, drugs and biologics.

The U.S. FDA’s remote regulatory assessment (RRA) program, the subject of a guidance the agency finalized in June 2025, is proving to be one of the trickier bits of navigation for makers of devices, drugs and biologics. RRAs were on tap at the 2025 enforcement conference held by the Food and Drug Law Institute, but the session seemed to suggest that industry may not be fully prepared for how the agency will conduct these reviews, but also what it will do with the results.

The U.S. FDA’s recent switch toward more routine use of generalist field investigators might be seen in some quarters as an attempt to do more with less, but a session on the topic at the Food and Drug Law Institute’s annual enforcement conference in Washington seems to suggest that this reversal of historic practice presents at least as many problems as solutions for industry.

One of the sessions at this year’s Food and Drug Law Institute’s enforcement conference dealt with the use of AI for FDA compliance activities, but the question of AI legislation also arose. The problem with AI legislation, said Nathan Brown of Akin Gump, is how to manage the details of any legislation, which presents enough drag that federally preemptive legislation stands a faint chance of passage anytime soon.

The FDA’s Center for Devices and Radiological Health (CDRH) will have its hands full with the roll-out of the overhauled quality management regulation, but this will have ripple effects on industry as well. Keisha Thomas, associate director for compliance and quality at CDRH, told an audience in Washington DC that risk management will be a big focus in FDA oversight and inspections in 2026, a point of emphasis that could lead to more routine compliance and enforcement action.

Sen. Bill Cassidy, R-La., who chairs the Senate Health, Education, Labor and Pensions Committee, released another letter to the American Medical Association regarding the activities of the AMA committee for CPT coding activities.