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US Regulatory Roundup, March 2022: QMSR Draft Highlights; More Headaches For Philips; Essure Wreaks Havoc

 
• By Shawn M. Schmitt

The US FDA’s proposed Quality Management System Regulation, more ventilator recall headaches for Philips, and ongoing problems with Bayer’s Essure birth control device topped our list of most-read articles in March.

US Top Stories
• Source: Alamy

Now that the US Food and Drug Administration is on track to roll out its new Quality Management System Regulation (QMSR) in the not-too-distant future, device makers around the globe are scratching their heads and wondering what they need to know to make their transition from the current Quality System Regulation (QSR) to the proposed – and eventually final – rule as seamless as possible.

In our most-read story from March, longtime industry experts Kim Trautman and Eric Henry highlighted a handful of things manufacturers should know about the QMSR, the draft of which...

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