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10 Things You Need To Know About FDA’s Proposed Quality Management System Regulation

 
• By Shawn M. Schmitt

Longtime industry experts Kim Trautman and Eric Henry highlight some of the more important takeaways from the US FDA’s draft rule that would create a new Quality Management System Regulation, or QMSR, to replace its current Quality System Regulation.

Abstract photo of darts.
• Source: Alamy

The US Food and Drug Administration says a draft rule that aims to replace its decades-old Quality System Regulation (QSR; 21 CFR, Part 820) with a new Quality Management System Regulation (QMSR) will help harmonize QMS requirements and get medical devices into the hands of patients more efficiently.

The agency released its long awaited draft reg, “Medical Devices; Quality System Regulation Amendments,” on 22 February, and published it in the Federal Register on 23 February

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