Yale had teamed up with Medtronic in one new FDA-funded project to improve post-market surveillance and use of registries. Duke University and the University of Washington have also received grants.
FDA Expands Partnerships With Universities As Part Of MDEpiNet Program
Article preview from "The Gray Sheet" - January 28, 2013
FDA is teaming up with Yale University and Medtronic, as well as Duke University and the University of Washington, in recently established partnerships to enhance the device center’s post-market surveillance program and further explore the use of device registries.
FDA established these partnerships through a grant proposal
the agency posted last summer. The proposal was part of CDRH’s expanded national medical device post-market surveillance strategy announced last fall. (See "FDA Unveils Plan To Strengthen Device Post-Market Surveillance" — "The Gray Sheet," Sep. 10, 2012.) Three distinct grants were awarded last September: one to the Yale University-Medtronic collaboration, one to Duke and one to the University of Washington.
The public-private partnerships are part of CDRH’s Medical Device Epidemiology Network Initiative, which focuses on promoting the development of national and international device registries. The three projects were each provided an initial first-year grant of up to $150,000, with an option to extend the grant for up to five years.
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