CDRH’s Shuren Talks MDUFA, Industry’s Premarket Wants, Emerging Technologies, And More In Wide-Ranging Interview

In an exclusive interview with Medtech Insight, FDA device center director Jeff Shuren said the agency will possibly discuss issues such as postmarket surveillance and patient engagement in upcoming MDUFA negotiations. He also talked about some recent big wins for the agency and his vision for the coming year.

CDRH Director Jeff Shuren in his office
CDRH director Jeff Shuren discussed his 2020 priorities with Medtech Insight at his FDA office in White Oak, MD, on 28 February • Source: Ferdous Al-Faruque

The top US medical device regulator wants industry and other stakeholders to think beyond premarket reviews in the next medical device user-fee negotiations, which are set to kick off in April.

Instead of focusing on premarket review metrics as the US Food and Drug Administration has done in past negotiations, Jeff Shuren, director of the agency’s Center for Devices and Radiological...

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