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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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A new office that will combine the review, compliance and surveillance functions of US FDA's device center in a "Total Product Life Cycle" (TPLC) model is moving closer to reality, center director Jeff Shuren said in an interview.

First announced last fall, the director of the Center for Devices and Radiological Health confirmed to Medtech Insight that the pending office now has a name: the Office of Product...

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