Devices

FDA Withdraws From Device Harmonization Group

FDA has withdrawn its membership in the 32-member medical device Global Harmonization Working Party (GHWP), which is chaired by China, after failing to persuade the organization to align with other international harmonization efforts, such as the International Medical Device Regulators Forum (IMDRF).

“Moving forward, FDA will spend the next few months refocusing its efforts and repositioning staff and resources to primarily work on IMDRF,” CDRH director Jeff Shuren said in an 11/27 letter announcing the agency’s withdrawal. “FDA’s efforts to advance global harmonization have been and will continue to be primarily through IMDRF.”

Shuren said his earlier decision to join GHWP was based on concerns over “divergent harmonization efforts” that did not align with FDA’s priorities, and a desire to merge the two organizations’ efforts. “When FDA became a member of GHWP in December 2021, we did not realize how divergent the two organizations, GHWP and IMDRF, had become and the major challenges that needed to be overcome for them to successfully work together,” he said in the letter.

Shuren said that the challenges recognized during FDA’s participation in GHWP include:

Leadership that is not diverse or representative of a global perspective on the Steering Committee, Technical Committee, and Strategic Advisory Board
Imbalance of regulator and industry participation in working groups that diminished the regulators’ perspectives
Lack of an alignment-based approach and transparency associated with document development
GHWP’s practices that duplicate and modify documents from other organizations leading to inconsistencies that undermined medical device global harmonization

Shuren said that as the chair of IMDRF for 2024, he will still look to “work collaboratively with as many entities as possible, including GHWP, the World Health Organization, Pan American Health Organization, African Medical Devices Forum, etc., to ensure alignment of medical device international harmonization efforts.” He also invited GHWP’s chair to attend a 3/2024 IMDRF meeting to continue discussions between GHWP and IMDRF and to provide a GHWP update.

There has been no news on whether any of the other 32 regulatory members plan to withdraw their GHWP membership.

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