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.
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...
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