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As the design, manufacture, distribution and use of medical devices have become increasingly complex and global, the need for harmonized approaches and reliance among regulatory authorities has become more vital. To that effect, today, the U.S. Food and Drug Administration (FDA) issued the draft Center for Devices and Radiological Health International Harmonization Strategic Plan. This plan includes specific strategies to directly encourage harmonization, convergence, and reliance among medical device regulatory authorities, as applicable, and builds on the work CDRH is currently doing with international stakeholders.
Strategic Plan Objectives:
- Strengthen diplomatic relations that promote alignment in best practices and inform risk-based decision making
- Encourage harmonization, convergence, and reliance among international regulatory authorities and other stakeholders
As part of our MDUFA V commitments and over the next four years, CDRH will provide updates on our work towards the strategies and activities outlined in this plan.
Questions?
If you have questions about the international harmonization strategic plan, contact the CDRH International Affairs team.
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