The Place To Be At FDA In 2018? Office Of Product Evaluation And Quality
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.
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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.
In an exclusive sit-down with Medtech Insight, CDRH Director Jeff Shuren talked about his priorities for his center over the next three years and how they could impact the medical device industry. The overall aim is to boost the number of novel medical devices that reach the US market first.
A new three-year plan to implement strategic priorities at US FDA's device center aims to make several broad improvements to the medtech ecosystem. Among them is improving staff incentives at the agency, creating more partnerships with industry and other stakeholders, and improving the center's processes to make it easier for novel medical devices to enter the US market.