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*CDRH Rare Disease Impact Initiative (RDII)

Forecast

Federal

Contract Overview

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AI Contract Overview

The CDRH Rare Disease Impact Initiative (RDII) is a Food and Drug Administration program designed to accelerate the innovation, regulatory review, and adoption of medical devices for patients with rare diseases. By utilizing a patient-centric approach and a national collaborative framework, the initiative seeks to remove barriers to access for therapeutic, diagnostic, and assistive devices. The program aims to position the FDA as a global leader in this field through continuous engagement with industry, academia, and the rare disease community. Key deliverables for fiscal year 2027 include conducting a comprehensive landscape analysis and needs assessment to develop specialized resources and data repositories. The initiative will also host at least three external stakeholder workshops and create two patient-centric educational modules. Additional core activities involve conducting regulatory science research, developing novel policies, providing internal staff training, and coordinating with other medical product centers via the Rare Disease Innovation Hub.

General Info

FDA program accelerating rare disease medical device innovation through research and stakeholder collaboration.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541618 - Other Management Consulting Services

Place of Performance

USA

Set-Aside

NONE

Documents

No documents available

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cdrh Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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.