Devices

FDA in 2 Collaborative Communities

FDA is currently a member of two collaborative communities that have been established and are managed and controlled by external stakeholders. Speaking at a 10/29 Webinar on collaborative communities, CDRH director of patient science and engagement Michelle Tarver identified the two groups as the Ophthalmic Imaging Collaborative Community that will seek to identify and clarify important challenges, clarify best practices, strategies and standards, and drive innovation within the general area of ophthalmic imaging, and the National Evaluation System for Health Technology Coordinating Center Collaborative Community, a national network intended to help develop methodologies designed to drive down the time and cost of real-world data collection and analysis and increase the value and use of real-world evidence to meet the needs of patients, payers, the medical device community, industry, healthcare professionals, and other regulatory bodies.

Tarver gave an overview of collaborative communities as viewed by CDRH. They are convened by interested stakeholders and appear organically, rather than at the direction or request of FDA. They may exist indefinitely, produce deliverables as needed, and tackle challenges with broad impacts.

“This mutually beneficial relationship is reinforced by shared responsibility and accountability for achieving results toward common goals,” Tarver said. “Participation in at least 10 collaborative communities by 12/31/2020 is one of CDRH’s strategic priorities.”

She said the Center encourages medical device stakeholders to consider forming collaborative communities and to consider requesting Center participation in appropriate cases.

The Webinar discussed what collaborative communities are and are not and the role FDA can and cannot play in such communities.

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