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Collaborative Communities: 

Addressing Healthcare Challenges Together

Michelle Tarver, M.D., PhD

Director, Patient Science & Engagement Program

Office of Strategic Partnerships and Technology Innovation

Center for Devices and Radiological Health

October 29, 2019
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Agenda

• The FDA’s Concept of a Collaborative Community 

• When CDRH May Consider Participating in a Collaborative 

Community

• Current Collaborative Communities with CDRH Participation

• Overview of the Collaborative Communities Toolkit

• Frequently Asked Questions

• Resources

• Q&A
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The FDA’s Concept of A Collaborative Community

• What Is a Collaborative Community?

• What Collaborative Communities Are Not

• Other Collaborative Groups Compared to a Collaborative 

Community

• Potential Outcomes of a Collaborative Community
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What Is a Collaborative Community?

Collaborative communities are continuing 

forums where public and private sector 

members proactively work together to: 

• Achieve common objectives and outcomes 

• Solve shared challenges

• Leverage collective opportunities in an 

environment of trust, respect, empathy 

and openness. 
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What 

Collaborative 

Communities 

Are Not

• They are NOT led by the FDA.

• They are NOT convened by the FDA.

• They do NOT exist to advise the FDA.

• Their membership and governance are NOT 

directed by the FDA.

• They are NOT task forces, working groups, or 

commissions.
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Other Collaborative Groups Compared to a 

Collaborative Community

Task Force Standards Collaborative Community

Establishment Usually initiated by a 

government entity Multiple mechanisms Convened by external partner, but the 

FDA may be a member of the community

Goals

Provides specific 

recommendations to 

address a single issue 

or concern 

One deliverable per 

workstream that gets 

updated

Focused on broader outcomes and 

impacts

May have multiple deliverables for each 

work stream 

Lifespan Limited duration Potentially sustained, 

intermittent 

Sustained duration with a potentially 

indefinite lifespan 

Members

Involves a more 

focused group, usually 

not all stakeholders

Involves a more 

focused group, 

usually not all 

stakeholders

All stakeholders are brought into the 

effort and have an equal voice in 

decisions
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Potential 

Outcomes of a 

Collaborative 

Community

Research Agenda 

or Projects

Peer-Reviewed 

Publications

Templates or 

Frameworks Tool Development Best Practices

White Papers

Health Care 

Coverage and 

Reimbursement 

Decisions
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When CDRH May 

Consider 

Participating in a 

Collaborative 

Community

• CDRH makes participation decisions on a case-bycase basis, based on:

• Public health impact 

• Alignment with CDRH mission, priorities and resources

• To help determine whether we will participate, we 

may consider, for example, whether the community 

has:

• A governance structure

• A convener

• A plan to measure success

• A mechanism for sustained engagement
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Current Collaborative Communities with CDRH 

Participation

• Ophthalmic Imaging Collaborative Community

• National Evaluation System for health Technology Coordinating 

Center (NESTcc) Collaborative Community 

– www.nestcc.org
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Overview of the Collaborative 

Communities Toolkit

Includes best practices for establishing and 

maintaining collaborative communities:

• Planning the collaborative community

• Gathering members

• Decision making

• Assessing the effectiveness, value and 

impact of the collaborative community
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Frequently Asked Question

Q: When should I talk to the FDA about a collaborative community?

Answer: We always encourage members of the public who are interested in 

tackling a matter of public health importance to engage in conversation with 

the FDA.

If you’re interested in having the FDA join as a member of a newly developed 

or existing Collaborative Community, contact us at 

CDRHCollabCommunities@fda.hhs.gov
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Q: Does the FDA establish or fund collaborative communities?

Answer: No. The FDA does NOT: 

• Establish, manage, or control collaborative communities. 

• Provide funding, decide the membership, schedule meetings or set 

agendas, or control the community's operations.

Collaborative communities can exist without the FDA's participation. 

Frequently Asked Question
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Frequently Asked Question

Q: Are collaborative communities an alternative to standards, federal 

advisory committees, or other established regulatory processes?

Answer. No. Collaborative communities do not replace established 

regulatory mechanisms. The FDA will follow good guidance practices, ethics, 

standards, and other existing process for conducting its business. The FDA's 

participation in collaborative communities must conform with these existing 

obligations. 

Note that a collaborative community is not a federal advisory committee. For 

more information on the FDA's advisory committees: 

https://www.fda.gov/advisory-committees/about-advisory-committees
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Q: Why would I want to be a part of a collaborative community?

Answer: We believe collaborative communities can contribute to 

improvement in areas affecting U.S. patients and healthcare and result in 

wide-ranging benefits for public health.

For example, collaborative communities could accelerate the development of 

science-based solutions to policy challenges related to assuring the safety 

and effectiveness of many novel areas of medical device innovation. 

Frequently Asked Question
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Resources

• FDA’s Collaborative Communities webpage (includes the toolkit)

https://www.fda.gov/about-fda/cdrh-strategic-priorities-andupdates/collaborative-communities-addressing-healthcarechallenges-together
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Questions?

About Collaborative Communities:

CDRHCollabCommunities@fda.hhs.gov

About Medical Device Regulation:

Division of Industry and Consumer Education

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar 

Recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics; 

Sub-Heading: Collaboration

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