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FDA's US-First Strategy: Device Center Sets Three-Year Goals

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.

Empty asphalt road and New year 2018, 2019, 2020 concept. Driving on an empty road in the mountains to upcoming 2018, 2019, 2020 and leaving behind old years. Concept for success and passing time.

US FDA's device center will focus on improving staff engagement, streamlining its core processes and boosting collaborations with stakeholder communities over the next three years. That's the message from its strategic priorities document published the agency's device center on Jan. 17. The overall aim: by 2020, to have a majority of manufacturers of novel technologies intend to bring their devices to the US first or in parallel with other major global markets.

Medtech Insight sat down with Center for Devices and Radiological Health (CDRH) Director Jeff Shuren to talk about how the...

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