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

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.