ARTICLE SUMMARY:
CDRH staffers won’t be in Tokyo for the IMDRF 27th session. Excerpted from Pathways’ Picks March 5: No FDA in Tokyo, Capitol Hill Picks, and Updates From the EU and UK.
The International Medical Device Regulators Forum biannual meeting will take place in Tokyo from March 10-14, but no FDA device staff are expected to be onsite at the meeting due to an agency-wide travel freeze. An FDA official affirmed that the travel restriction will block attendance at IMDRF but did not rule out that some CDRH staff could participate virtually. IMDRF’s Management Committee is chaired by Japan for 2025, but FDA plays a significant leadership role in the organization. For instance, CDRH staffers serve as co-chairs (typically with an official from one other IMDRF member agency) on six of the eight active IMDRF working groups that write all the organization’s guidelines and documents. IMDRF administers the global Medical Device Single Audit Program (MDSAP) and is developing a globally harmonized device submission template based on FDA’s electronic Submission Template and Resource (eSTAR), in addition to ongoing efforts in digital health, clinical evidence, and broader global “reliance” practices. A primary focus at the March 10-14 meeting, including public and closed-door committee deliberations, will be to discuss IMDRF’s 2026-2030 strategic plan.
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