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Industry Attorney Says FDA's New Device Plan Oversteps Authority

By David Roza / April 26, 2018 at 7:04 PM
An industry attorney leveled a lengthy critique at FDA's newly created Medical Device Safety Action Plan, calling different steps of the plan "extremely imperialistic," "expansionist," and outside of FDA's statutory authority as a regulatory agency. The attorney took issue with both aggressive regulatory approaches outlined in the plan, as well as the incentives FDA proposed to encourage development of safer medical devices. But an FDA spokesperson argued those critiques were unfounded, and noted that many of the proposals in the...


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