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Recently, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) began participating in three new collaborative communities in the medical device ecosystem:
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AI Global Healthcare Initiative Collaborative Community: Seeks to advance current approaches to improve patient health, product quality, and process improvement through the power of artificial intelligence (AI) and collaboration.
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Infection Management Collaborative Community: Aims to accelerate the development, availability, and adoption of safe and effective medical devices to prevent, diagnose, and manage infection; treat sepsis; and support sepsis patients and survivors.
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Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD): Seeks to describe the same diagnostic test the same way anywhere it is used in the health care ecosystem.
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Collaborative Communities
A collaborative community is a continuing forum in which private- and public-sector members, which can include the FDA, work together on medical device challenges to achieve common objectives and outcomes. They are convened by interested stakeholders and may exist indefinitely, produce deliverables as needed, and tackle challenges with broad impacts.
Participation in collaborative communities was one of CDRH’s strategic priorities for 2018-2020 and the FDA currently participates as a member of 14 collaborative communities. The FDA is open to participating in others. If you have a collaborative community in which you would like the FDA to participate, email CDRHCollabCommunities@fda.hhs.gov.
Questions?
If you have questions about collaborative communities, or if you have a collaborative community in which you would like the FDA to participate, email CDRHCollabCommunities@fda.hhs.gov.
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