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FDA Announces Withdrawal From Global Harmonization Working Party
November 27, 2023
Dear International Colleague,
Today, the U.S. Food and Drug Administration announced its withdrawal 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.
Read the letter from Jeffrey Shuren, M.D., J.D., Director of the FDA's Center for Devices and Radiological Health.
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