CDRH Seeks More Speed and Consistency in Premarket “Redesign”

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A newly formed working group within FDA’s device center has been tasked with making device premarket review processes more agile to improve efficiency and predictability by 2025.

FDA’s device center recently formed a working group to find ways to speed up its premarket review program with the aim to deliver results over the next year and a half. The effort was launched as part of CDRH’s overarching goal to simplify its internal processes, but it also responds to the challenges device reviewers face in getting back on track after the historic burdens of the pandemic.

“We slid a little bit backwards in some of the things we were doing because the center was being overwhelmed,” Jeff Shuren, director of CDRH, acknowledged during a recent presentation at the Medical Device Manufacturers Association annual meeting in Washington, DC. “That has led to being a little bit more conservative and also a little bit less predictable.”


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