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'Least Burdensome' Supersized? Draft Guidance Outlines An Expanded View Of The US FDA Concept

 
• By David Filmore

The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.

While US FDA's new draft guidance on the "concepts and principles" of the least burdensome provisions was prompted in part by last year's enactment of the 21st Century Cures Act, it is intended to go further than that, says device-center director Jeffrey Shuren.

"The approach that we are taking on least burdensome goes beyond what Congress has put into the law," Shuren told Medtech Insight. "It applies more broadly, and it goes more...

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• By Brian Bossetta

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More from Policy & Regulation

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Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
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