Article preview from "The Gray Sheet" - April 08, 2013
The heads of the newly formed private-public partnership comprising industry, academia and FDA describe the group’s top three projects to advance medical device regulatory science.
Medical Device Innovation Consortium Sets Priorities To Advance Reg Science
Article preview from "The Gray Sheet" - April 08, 2013
The Medical Device Innovation Consortium is officially up and running and planning its priority projects.
The public-private partnership was formed in December 2012 with the goal of advancing medical device regulatory science. The MDIC board, which held its first meeting in late February, includes leaders from medical device manufacturers, FDA, the National Institutes of Health, CMS and patient advocacy groups. (See "Medical Device Innovation Consortium Launches, Aims To Start Projects In 2013" — "The Gray Sheet," Dec. 10, 2012.)
The group, a 501(c)3 nonprofit organization, currently has 21 medical device companies signed on as members, and is looking to expand to more industry and nonprofit organizations. “We have buy-in from the FDA legal counsel to allow the FDA to formally collaborate in this precompetitive space with industry to really get at these important, large scale challenges that have had an impact on the pathway to approval,” said MDIC board Chairman William Hawkins in an interview.
MDIC’s top three priority projects relate to issues device makers have been discussing with FDA leaders for many years: clinical trial reform, computer modeling and simulation, and patient centeredness and risk management.
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