QSR Author Kim Trautman: FDA Should Change Name Of New Quality System Reg (And Other Thoughts)
How does “Quality Management System Regulation” sound?
The former FDAer who wrote the Quality System Regulation in the 1990s says the US agency should change the name of the rule, which has been undergoing a revision since 2018 to be harmonized with international quality systems standard ISO 13485. A name change would help delineate the retooled reg from its GMP predecessors, said Trautman, who also shared a few other thoughts about the agency’s ongoing QSR redo.
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After nearly four years of work, the US FDA has issued its new draft rule, “Medical Devices; Quality System Regulation Amendments.” If finalized, the QSR reg will be renamed the “Quality Management System Regulation,” or QMSR.
Another Delay On The Way? FDA’s Shuren Says Industry Should ‘Anticipate’ QSR Harmonization To Take ‘Little While Longer’
Jeff Shuren, director of the US FDA’s device center, signaled on 15 September that the agency might not have the hotly anticipated draft of its retooled Quality System Regulation ready for release by next month.
October 2020 is the new in-house target date for the US agency to release a draft of its revised QSR, which will be harmonized with international quality systems standard ISO 13485.