Industry Lawyers: FDA's Reg Paradigm For Software Requires Cultural Shift

July 06, 2018
Industry lawyers say FDA's ambitious goal of reviewing quickly evolving software-based medical devices in potentially 10 days or less is easier said than done, and requires a cultural shift in the agency from a purely science-based mindset to a business and organizational one. In a recent FDA Law Blog post, one expert referred to a concept floated by a high-level agency official for reviewing software-based medical devices in five to 10 days. While the concept was "certainly aspirational," another...

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