*CDRH Rare Disease Impact Initiative (RDII)

The CDRH Rare Disease Impact Initiative (RDII) is intended as a Center-wide initiative to facilitate the advancement of medical devices patients living with a rare disease or condition. Using a patient-centric approach, RDII aims to advance access to, and innovation of, medical devices for individuals living with rare diseases - who are often children - by establishing a national collaborative framework to address persistent barriers to the development, evaluation, regulatory review, and adoption of these devices.The ultimate goal of the RDII is for FDA, CDRH to be the global leader in facilitating access and innovation in medical devices for are disease. Core RDII activities will include:Hosting external workshops to engage patients, industry, academia, and other stakeholders. The RDII would like to establish a forum for external engagement and host at least 3 workshops in FY27.Developing resources, tools, and data repositories for the rare disease community, based on a landscape analysis and needs assessment conducted across the Center and the external rare disease community. RDII plans to conduct the landscape analysis and needs assessment in FY27. Conducting regulatory science research initiatives and developing novel policies for advancing devices for rare diseases.Maintaining continuous engagement with the internal and external rare disease community, including coordination with other medical product Centers through the Rare Disease Innovation Hub.Providing internal training to CDRH staff on rare disease considerations.Developing patient centric educational materials. The RDII would like to develop at least two educational modules in FY27.The activities of the RDII will span all device types including therapeutic devices, diagnostic devices which include digital health diagnostics, and assistive devices.

Estimated value

>= $3M and < $7M

Est. solicitation date

Jul 1, 2026

Anticipated award

Jan 1, 2027