One of the current strategic priorities for CDRH is the creation of Collaborative Communities to allow interested stakeholders (both private and public, including the FDA) to work together medical device challenges. These communities may be convened by any stakeholder, and “may exist indefinitely, produce deliverables as needed, and tackle challenges with broad impacts”. 

To further this priority, CDRH has developed a Collaborative Communities Toolkit to help establish and guide communities. This document is neither policy nor guidance, but a collection of best practices on how to establish, operate, and assess the value of the community. The communities are neither led by nor advise the FDA, though the agency may choose to participate as an active member to contribute towards the community’s goals, and may choose to adopt solutions proposed by the community where appropriate. One thing that seems missing to me is a clearer understanding of how CDRH intends to engage any particular Community.

The Toolkit may be downloaded here. The Center is also soliciting public comments on the Toolkit here.

Text Copyright © 2018 Katrina Rogers