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# FDA Annual Report on CDRH International Harmonization
- URL: https://www.fdaweb.com/fda-annual-report-on-cdrh-international-harmonization/
- Published: 2026-01-29T12:00:00.000Z
- Updated: 2026-09-14T15:31:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160570

As part of its MDUFA 5 commitment to promote international harmonization and provide additional CDRH resources for that work, the Center conducts annual assessments of its international activities. The 2025 [report](https://www.fda.gov/media/190767/download?attachment&ref=fdaweb.com) lists the five strategies envisioned in the CDRH strategic plan on international harmonization:

- increase engagements in international harmonization, convergence, and reliance efforts;
- create a mechanism for CDRH to share best practices with trusted partners;
- assess the extent of CDRH implementation of IMDRF (International Medical Device Regulators Forum) technical documents;
- support creation of a forum to engage with stakeholders to identify opportunities for regulators to leverage one another’s approach to decision-making; and
- participate in outreach activities to encourage harmonization, convergence, and reliance.

The report discusses accomplishments for each of the five strategies and pledges to continue the effort as MDUFA 5 enters its remaining years and FDA looks ahead to MDUFA 6.