ARTICLE SUMMARY:
In this week’s Pathways Picks: CDRH staffers won’t be in Tokyo for next week’s IMDRF meeting; center director Michelle Tarver and other leaders have kept a relatively busy schedule of closed-door meetings with stakeholders in recent weeks; no De Novo authorizations since January 20; FDA standards work is still limited; AdvaMed’s legislative priorities; structured dialogue, a new data regulation, and IVDR reference labs in Europe; and updates from the UK.
FDA Picks
IMDRF absence, De Novo watch, and more:
CDRH won’t be in Tokyo for IMDRF. The International Medical Device Regulators Forum biannual meeting will take place in Tokyo next week, 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.
Tarver keeps busy. Despite the radio silence from FDA on public communications and meetings since January 20, CDRH Director Michelle Tarver, MD, and other center leaders have kept a relatively active schedule of closed-door meetings with stakeholders. FDA posted a backlog of public calendar listings for agency and product center leaders March 5, identifying a total of 10 meetings held by Tarver and CDRH colleagues with device companies or other outside groups. For instance, CDRH met with Medtronic officials including CEO Geoff Martha February 25 to discuss “general medical device updates.” Center staffers also met with the wearables firm Oura Ring, the chemical company Chemours, the Medical Device Innovation Consortium, Roche, Philips, among others in recent weeks. Notably, the Acting FDA Commissioner Sara Brenner, MD, has no meetings recorded on the public calendar listings since she took on the role in late January.
