‘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
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.
