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FDA, Industry Group to Partner on Medical Device Regulation

Surgeon holds Medtronic pacemaker (Steve Winton/Flickr)The Food and Drug Administration will collaborate with LifeScience Alley, an industry association based in Minneapolis, in the Medical Device Innovation Consortium, to advance regulatory science for medical devices. Medical Device Innovation Consortium is expected to create scientific tools for assessing the safety and effectiveness of medical devices.

The consortium has nine corporate members, including industry leaders Medtronic, based in Minneapolis, and Boston Scientific. Medtronic’s Maura Donovan will serve as interim executive director of the consortium, on loan from Medtronic. Donovan was the company’s vice-president for therapy research and development.

Regulatory science aims to improve the ways products are developed and evaluated, as well as reduce the cost and time it takes for medical devices to come to market. FDA cites as an example, computer models that can test new types of implants before running costly and time-consuming clinical trials.

FDA’s Center for Devices and Radiological Health (CDRH) will represent FDA in the consortium. Jeffrey Shuren, director of CDRH says, “”By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost.”

LifeScience Alley says the consortium’s articles of incorporation have been filed with the state of Minnesota, and the organization will be applying for tax-exempt status with the IRS. Donovan is expected to recruit a board of directors, recruit members, and form committees to identify and lead projects.

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Photo: Steve Winton/Flickr

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