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FDA-Industry Consortium to Speed Device Reviews


Posted in Regulatory and Compliance by Heather Thompson on January 17, 2013

FDA has announced the creation of the first public-private partnership intended to promote medical device regulatory science with a focus on speeding product development, assessment, and review. The Medical Device Innovation Consortium (MDIC) is an independent, nonprofit corporation, created by the trade association LifeScience Alley. 

“MDIC will prioritize the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and pathway to market for these innovations,” an FDA release says. MDIC will “bolster the country’s investment in regulatory science research by pooling people, funding, resources, and ideas to develop new tools, models, and methods that may be utilized to better and more efficiently evaluate new devices,” it says. 

The collaboration will provide an “enormous contribution in promoting the broad regulatory science needs of the medical device community,” FDA commissioner Margaret Hamburg said on a media call. Regulatory science has been underfunded in the medical device area, and the agency and industry look to MDIC as a new model needed to help meet general regulatory science needs, she said. It will create a safe haven to foster pre-competitive collaborative research, and the group will make sure findings enter the public domain. Regulatory tools from the collaboration “will be validated and qualified such that we know that the result that come out of them are strong enough to make regulatory decisions,” added CDRH director Jeff Shuren.

Asked about MDIC’s priorities, LifeScience Alley president Dale Wahlstrom told the media that the collaboration would likely help improve communication between developers and reviewers because there often exists a lack of understanding about science and engineering principles. One of the first things out of the process should be a shared understanding of technical submission questions and standardized test methods, he said. 

Shuren said the collaboration will also lead to better computer models for devices that use brain electrodes. He said one of the challenges has been that the electrodes can corrode and animal models are limited. An artificial brain is under development that will allow a better understanding of electrode durability which will lead to better designed devices, he said.

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