Dive Brief:
- 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.
Dive Insight:
The FDA joined the GHWP in December 2021 with the goal of serving as a bridge between the organization and the IMDRF. At the time, the FDA didn’t realize how divergent the two organizations had become, Shuren wrote.
“I would like to see GHWP and IMDRF collaborating on the common goals of fostering global regulatory convergence and leveraging resources to make safe and effective medical devices available globally, not trying to compete with one another,” Shuren wrote. “Unfortunately, GHWP does not offer the opportunity for FDA and other regulatory bodies to have our voices heard and considered.”
Some of the FDA’s concerns include leadership that is not diverse or representative of a global perspective, an imbalance of regulator and industry participation in working groups, and a lack of transparency in the creation, review and finalization of documents.
Going forward, the FDA plans to refocus its staff and resources to primarily work with the IMDRF. The FDA will chair the IMDRF in 2024, and Shuren invited Xu to join the March IMDRF meeting to continue discussions between the two organizations.
“I am looking for a few champions to support this goal of alignment amongst the organizations and to build a solid bridge between GHWP and IMDRF. I hope I can count on your support and cooperation,” Shuren wrote.
Members of the GHWP include China, India, South Africa, South Korea, Chile and Saudi Arabia. Members of the IMDRF include the European Union, Canada, China, Japan, South Korea and Australia.
