Collaboration Details

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Title of Collaborative Activity:

NIH-FDA Medical Device Research Interest Group (MDRIG)

Description of Collaborative Activity:

MDRIG meets quarterly to share information and ideas on supporting research throughout the device development pipeline. Recent topics of interest included clinical innovation and translation efforts, artificial intelligence and machine learning in imaging, digital twins, and early feasibility supplements for the Small Business Innovation Research (SBIR) grantees that would facilitate grantee Food and Drug Administration (FDA) meetings and communication in the formative years to increase appropriate planning during the development of their technologies toward eventual FDA approval. Recently, a successful pilot program was launched through collaboration between the NCI and FDA. Scalability to other institutes was discussed. Supported by NIBIB, MDRIG continues to meet four times per year. In 2018, NIBIB hosted a trans-NIH workshop on gadolinium retention in patients after magnetic resonance imaging. Collaborators included the extramural medical imaging community. A subsequent widely referenced white paper identified gaps in knowledge and future areas for research. This workshop included FDA participation.

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, NCCIH, NHGRI, NIAAA, NIDCD, NIGMS, NIEHS, NLM, OD

HHS Agency Collaborators on this Activity:

CMS, FDA