last highlighted date: 2024-02-19
Highlights
- The U.S. Food and Drug Administration decided to withdraw from the Global Harmonization Working Party (GHWP), one of multiple groups working to align international standards for medical devices.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, raised concerns about “divergent harmonization efforts” in a Monday letter to Jinghe Xu, chair of the GHWP and deputy commissioner of China’s National Medical Products Administration.
Shuren’s concerns included efforts that do not align with the FDA’s priorities or international best practices and the lack of collaboration with the International Medical Device Regulators Forum (IMDRF), another international standards group.
- Tags: fda