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Medical Device CEO Laments ‘Anti-Industry’ FDA Culture

Is the agency stifling medical innovation?

Michael Causey
Wed, 04/18/2012 - 11:16
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While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own agenda” over dissenting science or how its own advisory boards vote on medical device classification is just part of a broader “systemic” problem with some at the agency.

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As reported earlier in Medical Device Daily and elsewhere, an FDA advisory committee hearing in February for cranial electrotherapy stimulator (CES) medical devices was flawed, in part FWL alleges, because the FDA violated its own rules in running the hearing. FWL filed a March 9, 2012, citizen’s petition challenging the FDA’s proposed classification of CES devices as high-risk or Class III devices.

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