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Will FDA Release Its Draft Quality System Reg This Year? All Signs Point To No

 
• By Shawn M. Schmitt

US FDA device center chief Jeff Shuren said in early May that the agency had a goal of releasing its draft harmonized Quality System Regulation “this year,” but comments he made at a recent industry meeting signal that the new QSR might not come until 2022.

Magic Eight Ball
• Source: Alamy

The director of the US Food and Drug Administration’s device center, Jeff Shuren, is signaling that the agency probably won’t issue a draft of its harmonized Quality System Regulation by the end of 2021.

Shuren said six months ago that an end-of-year release for the draft rule was the FDA’s goal. But he now says it’s the agency’s “hope” that the reg – which...

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