CRT features three FDA Town Halls sessions.
The Japan FDA and FDA Valve and Structural town halls take place Monday. Sessions in Japan FDA include the “Harmonization by Doing” process between the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, early feasibility studies in the two countries, and the globalization of endovascular dialysis access and treatment-related devices. The FDA Valve and Structural Town Hall includes sessions on left trial appendage closure, transcatheter mitral valve repair and replacement devices, and transcatheter tricuspid repair and replacement devices.
The HHS/FDA Town Hall takes center stage Tuesday. Talks focus on U.S. Early Feasibility Studies, programs for innovative devices, the European regulatory landscape, lessons from the Japan-U.S. Harmonization by Doing initiative, and the impact of healthcare reform on innovation.
FDA Valve & Structural Town Hall
Japan FDA Town Hall
HHS/FDA Town Hall