Pathways' Pick of the Week: FDA Quits Harmonization Group

ARTICLE SUMMARY:

FDA is no longer part of the Asia-based Global Harmonization Working Party. Excerpted from Pathways' Picks November 29: Global Disharmony, Brazil Pilot, Software Notified Body, and More.

The FDA withdrew its membership in the Global Harmonization Working Party (GHWP) November 27 after concluding the group “does not offer the opportunity for FDA and other regulatory bodies to have our voices heard and considered.”

“When FDA became a member of GHWP in December 2021, we did not realize how divergent the two organizations, GHWP and the International Medical Device Regulators Forum (IMDRF), had become and the major challenges that needed to be overcome for them to successfully work together,” CDRH Director Jeff Shuren wrote in a November 27 letter to JInghe Xu, deputy commissioner of China’s National Medical Products Administration and chair of GHWP, notifying him of the agency’s withdrawal.

“FDA will spend the next few months refocusing its efforts and repositioning staff and resources to primarily work on IMDRF.”

In his letter, Shuren cited multiple complaints about GHWP operations. In particular, the CDRH chief said key GHWP committees did not represent a “global perspective,” that its procedures lack transparency, and he suggested that industry viewpoints sometimes crowd out regulator perspectives.

He also cited “GHWP’s past and recent practices to duplicate and modify documents from other organizations leading to inconsistencies and undermining efforts to truly promote global harmonization and convergence for medical devices.”

FDA’s decision also comes as the agency is preparing to take over the chairmanship of IMDRF in 2024. (It rotates annually among the 11 regulatory authorities that make up the IMDRF management committee.)

Shuren suggested he will take steps to try to bridge the gaps with GHWP in the IMDRF leadership role.

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