On November 27, the FDA announced its withdrawal as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA stated that it 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).
The FDA cited the following benefits of working with IMDRF:
- The FDA, and other international regulators, are a part of the decision-making process.
- Decisions are made by consensus of all regulators on the management committee.
- Development of documents is driven by regulators.
- There is a clear and consistent public consultation process to allow for stakeholder engagement.
On September 18, 2023, the FDA issued the draft Center for Devices and Radiological Health International Harmonization Strategic Plan. This plan includes strategies to directly encourage harmonization, convergence and reliance among medical device regulatory authorities, as applicable, and highlights CDRH’s current work with international stakeholders.
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