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HHS Secretary’s Regs Sign-Off Requirement Will Kick FDA’s Draft QSR Into 2021, Expert Predicts

 
• By Shawn M. Schmitt

Kim Trautman, who authored the US FDA’s Quality System Regulation in the 1990s, tells Medtech Insight that the agency probably won’t release a draft of its updated, harmonized QSR until next year thanks in part to a recent move by HHS secretary Alex Azar to personally sign off on every rule.

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Kim Trautman, the author of the US Food and Drug Administration’s Quality System Regulation, predicts the agency won’t release a draft of its updated QSR until next year thanks in part to a recent move by Department of Health and Human Services (HHS) secretary Alex Azar to personally sign off on every rule.

The FDA has been harmonizing its QSR (21 CFR, Part 820) with international quality systems standard ISO 13485:2016 for more than two years. The agency has missed three internal deadlines...

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