Push and Pull on EU Reforms, CDRH Guidance Priorities, and More
In this week’s Pathways Picks: A debate over the proper speed of EU MDR/IVDR reforms; FDA’s device center issues its FY 2025 guidance priorities, and it posts new details on device trial demographics; EU and ISO actions on standards; progress toward a "breakthrough" Medicare coverage bill; Japan regulator PMDA plans to open up its first office in Washington DC; and more from FDA and the International Medical Device Regulators Forum.