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The FDA’s Center for Devices and Radiological Health (CDRH) has launched the CDRH Rare Disease Impact Initiative to help address challenges associated with rare disease device development - such as small patient populations and the complex nature of many rare diseases - and facilitate the advancement of medical devices for people with rare diseases.
The initiative’s new webpage provides tools and resources that may help advance rare disease medical devices, including:
- CDRH’s Rare Disease Medical Device List
- Information on FDA programs available to support the development of medical devices for rare diseases
- Upcoming events and opportunities for patient and caregiver engagement
Questions?
If you have questions about the CDRH Rare Disease Impact Initiative, please contact CDRH-Rare@fda.hhs.gov.
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