FDA announces Medical Device Innovation Consortium (US)

The US Food and Drug Administration (FDA) announced the formation of the Medical Device Innovation Consortium (MDIC) with LifeScience Alley (LSA), a Minnesota-based biomedical trade association. More exactly, the MDIC consists of the FDA’s Center for Devices and Radiological Health (CDRH) and the LSA. For FDA this is unusual–according to the release it is “the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices.” LSA includes in its nearly 700 organization membership the Mayo Clinic, Medtronic, St. Jude Medical and University of Minnesota. While this is about biomedical devices, if successful in 1) creating a review model and 2) speeding up the process, it will definitely impact the relations that FDA has with the connected health area, or even expand to include it. (Now if we could also get the FCC into this streamlining….) But the Feds give with one hand and take away with another, with the ACA’s 2.3% excise tax on medical devices (all those implants and stents) starting in January and IRS final regulations now released. FDA release LSA/MDIC release CBS News article

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