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Stacking Bricks: FDA Unveils Structure For New Office Of Product Evaluation And Quality, Touts Benefits Of OPEQ

 
• By Shawn M. Schmitt

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.

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US FDA has given the device industry its biggest peek to date into how it plans to organize its Office of Product Evaluation and Quality (OPEQ) – the mammoth new bureau that will gobble up the duties of a handful of current, distinct offices that handle pre-market, compliance, enforcement and post-market surveillance activities.

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