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BREAKING: FDA Releases ‘Quality System Regulation Amendments’ Draft Rule

 
• By Shawn M. Schmitt

After nearly four years of work, the US FDA has issued its new draft rule, “Medical Devices; Quality System Regulation Amendments.” If finalized, the QSR reg will be renamed the “Quality Management System Regulation,” or QMSR.

QSR-ISO_193503416

After nearly four years spent retooling its Quality System Regulation – 21 CFR, Part 820 – the US Food and Drug Administration on 22 February finally released its draft rule that harmonizes the QSR with ISO 13485:2016.

“While the current QS regulation provides sufficient and effective requirements for the establishment and maintenance of a quality management system, regulatory expectations for a quality management system have evolved since the regulation was implemented over 20 years ago,” the agency says of its 52-page draft, “

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