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‘If You Know The Answer, Let Me Know’: FDA’s Shuren Mum On 1 Year Transition For Coming QMSR Reg

Industry groups and other stakeholders have requested more than a year to comply with the Quality Management System Regulation, when finalized

 
• By Shawn M. Schmitt

Jeff Shuren, director of the US FDA’s device center, said on 4 May that the agency “thought it was enough time” when it proposed a one-year transition time frame from its current Quality System Regulation to the new Quality Management System Regulation.

Sand running through the bulbs of an hourglass.
• Source: Shutterstock

The director of the US Food and Drug Administration’s device center, Jeff Shuren, said on 4 May that the agency “thought it was enough time” when it proposed what some consider a swift one-year transition from its current Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR).

The QMSR was released as a draft rule in late February. When finalized, it will replace the QSR, which has...

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