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

Executive Summary

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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As Expected, FDA Misses Fourth Consecutive Deadline For Releasing Draft QSR

The US FDA’s internal deadline of October 2020 for putting out a draft of its retooled Quality System Regulation is the fourth it failed to meet. The agency has been harmonizing its decades-old QSR with ISO 13485:2016 for more than two years.

‘Wrong Move’: Gottlieb Blasts Azar’s Perceived Regulatory Power Play Over FDA; HHS On Defense

The US HHS played defense on 20 September, pushing back on suggestions that secretary Alex Azar’s recent move to exert control over regulations by signing off on them was a power play aimed at the FDA. Meanwhile, former agency head Scott Gottlieb says it’s “the wrong move at the wrong time.”

Another Delay On The Way? FDA’s Shuren Says Industry Should ‘Anticipate’ QSR Harmonization To Take ‘Little While Longer’

Jeff Shuren, director of the US FDA’s device center, signaled on 15 September that the agency might not have the hotly anticipated draft of its retooled Quality System Regulation ready for release by next month.

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