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FDA’s Retooled Quality System Regulation Coming ‘Sometime This Year,’ CDRH Chief Shuren Says

Executive Summary

In an exclusive interview with Medtech Insight, FDA device center director Jeff Shuren wouldn’t commit to meeting the agency’s internal deadline of April for putting out a draft version of its revised Quality System Regulation, which will be harmonized with international standard ISO 13485. Instead, he would only say that the rule would likely be out “sometime” in 2020. Shuren added that the FDA wants to “hit the ground running” when the new QSR is eventually finalized.

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