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Compliance Corner: 4 Things You Should Do Now To Prep For FDA’s New QMSR Reg

 
• By Shawn M. Schmitt

Morgan Lewis partner Dennis Gucciardo says there are steps device makers can take to make sure they’re not caught behind the 8 ball once the US FDA’s proposed Quality Management System Regulation is finalized.

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Sure, medical device makers will have a full year – or perhaps more if industry has its way – to comply with the US Food and Drug Administration’s proposed Quality Management System Regulation (QMSR) once it’s finalized. But there are steps manufacturers can take now to prep for the forthcoming rule, an attorney says.

The FDA released its draft QMSR rule last month. When finalized, it will replace the agency’s Quality System Regulation, which has been the bedrock rule for making safe and effective...

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