Podcast Exclusive: Jeff Shuren Discusses FDA's Device Strategic Priorities
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.
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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.
A year after the NEST Coordinating Center was launched, the group has expanded its staff and now it wants to get a data network in place by year's end with real-world evidence information that device manufacturers can use to impress US FDA reviewers.
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.