27 November 2023
The FDA announced today that it is withdrawing “as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA will continue its outreach to global partners and its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). In 2024, the FDA, as chair of IMDRF, will continue to work collaboratively to reach consensus on common goals, foster global regulatory convergence, and leverage resources to make safe and effective medical devices available globally.”
The letter sent to the GHWP can be downloaded or viewed below. It is pretty critical of the GHWP processes including leadership not being diverse or representative of a global perspective in the major committees; the imbalance of regulator and industry participation in working groups impacting work not representing the regulator’s perspective; and more….
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