Collaboration Details

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Title of Collaborative Activity:

NIH-FDA Medical Device Research Interest Group (MDRIG)

Description of Collaborative Activity:

The Medical Device Research Interest Group (MDRIG) meets quarterly to share information and ideas on supporting research throughout the development pipeline. Recent topics of interest include an early feasibility supplement for the Small Business Innovation Research (SBIR) grantees that would facilitate grantee Food and Drug Administration (FDA) meetings and communication in the formative years in order to increase appropriate planning during the development of their technologies toward FDA approval. The National Heart, Lung, and Blood Institute (NHLBI) is supporting a pilot of this concept and the group will incorporate feedback from this pilot into their planning. NIBIB hosted two large workshops on AI in Medical Imaging that included the FDA and CMS – one in August 2018 and another in November 2019. These were funded through the NIBIB. In 2018, we also had a workshop on post-MRI Gadolinium Retention in patients. Funded by NIBIB.MDRIG continues to meet several times per year. In August 2020, NIBIB contracted the Medical Imaging & Data Resource Center (MIDRC), which includes FDA participation in a collaborative project.

Type of Collaborative Activity:

Committee, Advisory Group, or Work Group

Year the Collaborative Activity Originated:

2016

NIH Participating Institutes/Centers/Office of the Director:

NCATS, NCI, NEI, NHLBI, NIA, NIAID, NIBIB, NICHD, NIDDK, NINR, OD/DPCPSI/ORIP, FIC, NIAMS, NIDA

HHS Agency Collaborators on this Activity:

CMS, FDA