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 been the bedrock rule for making safe and effective devices...
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