Citing increasingly divergent harmonization efforts for medical devices, the U.S. Food and Drug Administration (FDA) has announced its withdrawal from the Global Harmonization Working Party (GHWP).
The FDA formally notified the GHWP of its decision in a letter to Jinghe Xu, Chair of the GHWP, sent in late November. The letter, signed by Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH), expressed concern about the divergence between the harmonization efforts of the GHWP and the International Medical Device Regulators Forum (IMDRF), the leading international consortium of medical device regulators.
In their letter, Shuren cited multiple concerns about GHWP’s harmonization efforts to date, including a lack of leadership that is “not diverse or representative of a global perspective,” “an imbalance of regulator and industry participation in working groups, often resulting in work items that do not represent the regulator’s perspective,” and a “lack of an alignment-based approach and transparency with processes and procedures in the creation, review, and finalization of documents.”
“I would like to see GHWP and IMDRF collaborating on the common goals of fostering global regulatory convergence…(and) not trying to compete with one another,” Shuren said. Toward that end, Shuren invited Xu to attend the next meeting of the IMDRF, scheduled for March 2024 in Washington, D.C.
