Planned US Device-Center Reorg Will Be Organized Around Device Types
CDRH compliance official Sean Boyd described agency plans to group staff in device-specific offices that would handle products from pre-market review through inspections and enforcement. If approved, the reorganization would go forward in 2018.
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Stacking Bricks: FDA Unveils Structure For New Office Of Product Evaluation And Quality, Touts Benefits Of OPEQ
US FDA's Sean Boyd gave an inside look at how the agency plans to organize its Office of Product Evaluation and Quality (OPEQ) – the so-called "super office" that will consolidate a handful of current, distinct offices that handle pre-market, compliance, enforcement and post-market surveillance activities. Plus: Five expected benefits for device-makers (and five for FDA) under the OPEQ reorganization are highlighted.
US FDA's device center is making good headway toward informally launching its new total product lifecycle "super office" as soon as possible this year and making the reorganization official by the end of 2018, CDRH Director Jeff Shuren said in an interview.
Having trouble keeping track of the many pilot programs offered by US FDA's device center? Then this handy listing of ongoing pilots should help.