The Stakeholder Council is a high-level convening organization of the executive leadership of organizations with a stake in the system of medical device evaluation. This Council will be convened directly by the MDEpiNet Coordinating Center, and like the existing Interim Stakeholder Council will be charged with providing strategic guidance and aid for development of the medical device evaluation system. The Council meets remotely ad hoc as needed, but face to face at least once per year.
The Stakeholder Council engages leadership from a broad range of organizations, including (but, not limited to):
- S. FDA CDRH Pre-Market Group
- S. FDA CDRH Post-Market Group
- Medical Device Industry
- Interested Foundations and Trusts
- Data Partners
- Hospital Systems, Private, University and Federal
- MDEpiNet Science and Infrastructure, Methodology, and Coordinating Centers
- Patient Advocates
- Medical claims payers
- Professional medical societies
The Council considers specific requests from the EOC regarding strategic prioritization, in-kind aid, and system support. They give guidance and assistance to the EOC as their means allow.
The Stakeholder Council will have no direct standing deliverables.
Elise Berliner, PhD (Co-chair)
David Feigal, MD (Co-chair)
Danica Marinac-Dabic, MD, PhD, MMSc