FDA Publishes CDRH International Harmonization Annual Assessment for Fiscal Year 2025

By Amelia Boldrick

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has published (January 29) its International Harmonization Annual Assessment for Fiscal Year (FY) 2025, covering October 1, 2024 to September 30, 2025 around the same time as its 2025 CDRH Annual Report.

Background on the CDRH International Harmonization Annual Assessment

The CDRH made several commitments and allocated resources to further international regulatory harmonization in the Medical Device User Fee Amendments 2022 (MDUFA V). The MDUFA V commitments led to the development of the CDRH International Harmonization Draft Strategic Plan in 2023, which outlines the strategies for international harmonization for FY 2023 – 2027. CDRH assesses these annually as another obligation of MDUFA V. 

Five key strategies

CDRH published its first annual assessment last year for FY 2024, using the five key strategies outlined in its Strategic Plan as assessment criteria. 

The FY 2025 assessment follows the same rubric, describing CDRH activities corresponding to the following five strategies:

1. Increase engagements in international harmonization, convergence and reliance efforts
2. Create a mechanism for CDRH to share best practices with trusted partners
3. Assess the extent of CDRH implementation of IMDRF technical documents
4. Support creation of a forum to engage with stakeholders to identify opportunities for regulators to leverage one another’s approach to decision-making
5. Participate in outreach activities to encourage harmonization, convergence, and reliance

IMDRF activities and accomplishments

After concluding its term as the International Medical Device Regulators Forum (IMDRF) Chair, Secretariat, and champion of regulatory reliance at the end of 2024, CDRH remains active in the IMDRF as one of its Management Committee members. CDRH participated in all eight and co-chaired six of the IMDRF working groups last year, with four technical documents (two on medical device software) and one information document published during FY 2025. CDRH has now implemented 22 of the 34 IMDRF technical documents, including the two on medical device software, and has partially implemented the remaining 12.

Advancement of MDSAP program

CDRH continued to contribute to the Medical Device Single Audit Program (MDSAP) to advance a global perspective on medical device auditing and manufacturing oversight as one of the program’s Regulatory Authority Council (RAC) members. MDSAP participation expanded in FY 2025 to include Malaysia and South Africa as Affiliate Members and Singapore as an Official Observer, ending the year with 15 participating Auditing Organizations. Interestingly, South Africa was omitted as a new Affiliate Member in the CDRH assessment. In the 2026 – 2027 term, CDRH will act as Chair of the RAC to increase program engagement in Asia.

Other FY 2025 highlights

• The Multilateral Brain-Computer Interface (MBCI) Forum, created by CDRH in FY 2024 and currently comprised of six global regulatory authorities, convened virtually twice in FY 2025 to share regulatory intelligence and harmonize review of these rapidly evolving devices
• CDRH held two virtual meetings with representatives of the medical technology association AdvaMed and other industry stakeholders on regulatory reliance, training and future projects
• CDRH met with regulatory authorities in Europe to discuss the U.S. premarket regulatory process and potential opportunities for regulatory reliance on U.S. marketing authorizations

Concluding remarks

As a founding member of the now-defunct Global Harmonization Task Force and its predecessor, the IMDRF, the FDA has long played a leading role in global harmonization efforts. CDRH made great strides in advancing medical device regulatory harmonization, convergence and reliance in FY 2025. In addition, the 21 CFR 820, Quality Management System Regulation, now incorporates by reference ISO 13485:2016.

We at Emergo by UL look forward to the further advancement of these goals in 2026.