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QSR Author Kim Trautman: FDA Should Change Name Of New Quality System Reg (And Other Thoughts)

How does “Quality Management System Regulation” sound?

Executive Summary

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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FDA Sets (Another) Deadline For Releasing Draft Harmonized Quality System Regulation

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.

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