Device regulation is about to change in ways large and small, as the CDRH moves toward a total reorganization.
CDRH’s reorganization plan — to be carried out over the next two years — aims to replace current siloes of responsibility with a team approach that follows a device from development to application to premarket planning and ultimately to postmarket surveillance, with the same people working together at each stage.
CDRH Reorganized lays out all of the moving pieces and lets you know what to expect, how to take advantage of new opportunities and how to influence the direction of the new system. And you’ll hear it from one of the people most qualified to interpret the changes, former CDRH Associate Director of Policy Paul Gadiock.
Gadiock recommends devicemakers get in on the ground floor of this reorganization. “Disruption can be unsettling,” he says, “but if you’re attentive, it also presents opportunity for new ideas because there’s less inertia standing in your way.”
You will learn:
The planned structure of CDRH’s regulatory and clinical evidence offices
The most effective strategies for communicating with the FDA post-reorganization
How the center’s new focus on total product life cycle will drive premarket and postmarket data collection
How the new CDRH Digital Health unit will help streamline the review process for digital health devices
The projected timeline for the reorganization and the impact of current high-level center vacancies
The new three-division structure of the CDRH inspectorate
Order your copy of CDRH Reorganized: New Strategies for Devicemakers and learn how to deal with the new CDRH structure at each stage of your device’s life cycle.
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PDF Edition — $397
Who Will Benefit
Regulatory affairs staff
Quality systems managers
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