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Rep. John Shimkus, Architect Of Cures Bill Device Reform Provisions

Rep. John Shimkus, R-Ill. distinguished himself as a champion of the sector with the slew of FDA device reforms that he sponsored 21st Century Cures discussion draft released by House Energy and Commerce last month.

Shimkus' provisions, in particular, closely match AdvaMed's recently unveiled "Innovation Agenda" priorities, including measures to use a third-party quality system audit to replace a new 510(k) for minor modifications, to...

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