*CDRH Rare Disease Impact Initiative (RDII)
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $3,000,000 to $7,000,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CDRH Acquisition Liaison cdhracquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration's Center for Devices and Radiological Health is procuring support for the Rare Disease Impact Initiative (RDII), a center-wide program to advance medical device innovation and access for patients living with rare diseases using a patient-centric approach. Core activities include hosting at least three external workshops in FY27 to engage patients, industry, academia, and stakeholders; conducting a landscape analysis and needs assessment across the Center and external rare disease community; developing resources, tools, and data repositories; conducting regulatory science research and developing novel policies; maintaining continuous internal and external engagement including coordination through the Rare Disease Innovation Hub; providing internal CDRH staff training on rare disease considerations; and developing at least two patient-centric educational modules in FY27. The initiative will address medical devices across all device types, including therapeutic, diagnostic (including digital health), and assistive devices. The solicitation is estimated to release July 1, 2026, with award anticipated January 1, 2027.
The estimated award value ranges from three million to seven million dollars. Work will be performed on behalf of the FDA's Center for Devices and Radiological Health. Inquiries should be directed to the FDA's CDRH acquisitions mailbox at cdhracquisitions@fda.hhs.gov.
Forecast text
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.
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