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Reminder: Time’s Running Out To Comment On FDA’s Draft Quality Management System Regulation

 
• By Shawn M. Schmitt

The deadline is 24 May to comment on one of the biggest regulatory changes in the history of the US FDA’s device center.

String on a finger to remember.
• Source: Alamy

As of 12 May, 34 stakeholders have commented via Regulations.gov on the US Food and Drug Administration’s draft Quality Management System Regulation (QMSR). Of those, 32 have been made public.

There are only a dozen days left for industry and others to make their voices heard in the shaping of the agency’s replacement for its decades-old Quality System Regulation (QSR).

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