Questions for CDRH Engagement Team for Collaborative Community

How do we move from where we are now to the established decision making practices / accepted charter etc?

• Slide deck with more information about Collaborative Communities: https://aphlinformatics.atlassian.net/wiki/download/attachments/1533050888/Tarver_CollabComm_external stakeholders_2022.pdf?api=v2

• Process:

  • Send existing charter to Engagement group

  • Ask for FDA rep

  • They review might suggest additional stakeholders and ensure there is not already a collaborative community for that topic

  • if they are ok, then it gets forwarded to the Steering Committee and then gets buy-in from the Center leadership and commitment of 1 person and the executive sponsor

• Benefits:

  • Improve visibility to attract more stakeholders

  • Access to collaborative community network to ensure efficient learning

• NOTE: Federal Advisory Committee text prohibits FDA involvement in the writing of the charter (any fed partner)

Will there be some funding for the collaborative community (logistics support)?

• That is up to the communities to organize - there is no support available from FDA (since that could be viewed as influencing the community, which could render any work product from that community null and void.

We didn’t get to these questions:

• How do you decide, if you need to be able to be an organization that can take funds vs. utilizing stakeholders in the community to receive funds, if available and report back?Related to logistics support: How does ONC or CLIA have FACS?

• Do we need a coordinating center for all the stakeholders?

• Does communication material from a collaborative community have to go through FDA clearance?