ARTICLE SUMMARY:
FDA’s device center touts its accomplishments in advancing global harmonization in FY 2025. Exerpted from Pathways’ Picks February 4: FDA Adopts QMSR, EU Harmonizes Standards, South Korea Spotlights Innovation.
FDA’s device center published a report last week outlining its accomplishments in advancing global harmonization in FY 2025. The report satisfies a user fee program commitment and provides a space for CDRH to spotlight its work with the International Medical Device Regulators Forum, MDSAP, and various bilateral and multilateral engagements with other countries. The details are not remarkable, but the fact that the agency is signaling full-throated commitment to continuing its harmonization work is notable considering actions taken by the Trump administration early last year that seemed to go in the opposite direction, including FDA not attending the March 2025 IMDRF meeting in Japan in person and restrictions on agency staff participating in global standards development organizations. “Our ongoing participation in international forums … will continue to support alignment of regulatory approaches and effective information sharing across the global regulatory community,” the January 29 report states.