One of the Center for Devices and Radiological Health’s (CDRH’s) strategic priorities for 2018-2020 is the creation of collaborative communities to bring together medical device stakeholders to achieve common outcomes, solve shared challenges, and leverage collective opportunities. CDRH believes collaborative communities can contribute to improvements in areas affecting U.S. patients and healthcare. We encourage interested stakeholders to learn more about collaborative communities and review the toolkit, which provides a collection of helpful ideas to foster strong collaborative communities that are well-prepared to take on healthcare challenges.
On this page:
- What Is a Collaborative Community?
- Members of a Collaborative Community
- Collaborative Communities Toolkit: Download and Comment
A collaborative community is a continuing forum in which private- and public-sector members, including 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.
A collaborative community may be appropriate when one or more of the following conditions are met (but are not limited to the conditions on this list):
- Challenges are ill-defined or there is no consensus on the definition of the challenges
- Challenges and outcomes are complex
- Partners are interrelated
- Incremental or unilateral efforts to address the challenge have been ineffective
- Partners seek to optimize efforts, including preventing duplication of efforts
- Better outcomes could be achieved with integrating different perspectives, experiences, resources, and expertise
Collaborative communities typically include diverse, relevant organizations and individuals impacted by a specific topic. For example, patients and care-partners, academicians, health care professionals, payers, federal and state agencies, international regulatory bodies, and industry may be engaged as part of a collaborative community.
Members of a collaborative community may represent many types of medical device stakeholders. Read the Collaborative Communities Toolkit to learn more.
Collaborative Communities Toolkit: Where to Download and How to Submit Comments
The Collaborative Communities Toolkit is a collection of materials designed to help a community become established, to encourage effective collaboration, and to foster rich communities that are adequately prepared to take on healthcare challenges.
Each component of this toolkit is intended to help existing as well as burgeoning communities work with one another.
Questions about Collaborative Communities may be sent to CDRHCollabCommunities@fda.hhs.gov.