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'Super Office' To The Rescue: FDA's Device Center Is About To Undergo A 'Total Product Life Cycle' Makeover

CDRH Director Jeff Shuren told industry that the device center is moving quickly to establish a "super office" to tackle the full spectrum of pre- and post-market issues to reduce inefficiencies to replace the more siloed approach. Chief Scientist Bill Maisel has already been named a director.

Jeff Shuren
CDRH Director Jeff Shuren took industry questions at AdvaMed's Medtech Conference 2017 FDA town hall • Source: Ferdous Al-Faruque

US FDA's device center is moving quickly on a major reorganization that will essentially dissolve and replace the Office of Compliance, Office of Surveillance and Biometrics, and Office of Device Evaluation into one "super office" that would fulfill a "Total Product Life Cycle" (TPLC) scheme the agency has long envisioned.

The yet-unnamed office would have jurisdiction not just to review and greenlight products in the pre-market stage, but continue to assess them and the manufacturers that make them after they've...

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