Findings
Collaborative Communities are sustained, multi-stakeholder forums (including patients, industry, academia, and the FDA) dedicated to solving shared challenges in the medical device ecosystem. These communities are not intended to replace formal regulatory mechanisms. They are equipped to perform activities such as:
Developing best practices and strategies.
Generating and evaluating evidence to support novel approaches.
Clarifying ill-defined challenges and generating consensus on definitions.
Addressing issues related to product quality and safety.

Recommendations
The FDA/CDRH does not establish or fund these communities. Instead, the FDA recommends that interested stakeholders convene and lead these groups. The FDA reviews opportunities on a case-by-case basis for participation, considering:
The community’s potential public health impact.
Alignment with the CDRH mission, priorities, and resources.
The existence of a formal governance structure, a convener, a plan to measure success, and a mechanism for sustained engagement.

Regulatory Considerations
The FDA’s participation in these communities is a strategic priority for advancing regulatory science and fostering responsible medical device innovation. Examples of digital health-related collaborations include those focused on AI/ML, Digital Biomarkers, Digital Health Technologies (DHTs), and Real-World Data (RWD). The outcomes developed by these groups can inform and accelerate the development of science-based solutions to policy and scientific challenges.