Collaboration Details

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Title of Collaborative Activity:

Understanding and Identifying the Needs for Medical Devices

Description of Collaborative Activity:

The Institute of Medicine Rare Diseases and Orphan Products 2010 Report recommended that the Food and Drug Administration (FDA) and National Institutes of Health (NIH) perform an assessment of unmet devices needs, and determine the impediments, and options for overcoming these impediments. The assessment was completed and analyzed in 2017. A manuscript and report have been written and will be published soon. The assessment will document examples of compelling unmet needs across sections of medical specialties. Collaborating are the Office of Rare Diseases Research at the National Center for Translational Science (NCATS), and the Office of Orphan Product Development and other parts of the FDA.

Type of Collaborative Activity:

Committee, Advisory Group, or Work Group

Year the Collaborative Activity Originated:


NIH Participating Institutes/Centers/Office of the Director:


HHS Agency Collaborators on this Activity: