Familiar Names To Top US FDA's Reorganized Cardiovascular Devices Office
Companies that have brought products through US FDA's current cardiac device review office will come across many of the same review managers in the newly forming Office of Cardiovascular Devices, which will also include a few compliance and surveillance officers on the leadership team. The new office will sit within the device center's nascent "total product lifecycle" Office of Product Evaluation and Quality.
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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.
'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.
Medtech Insight spoke to attorney Greg Dadika about mass tort litigation, including industry trends, how to find the right law firm, and when it’s the right time to settle a suit.