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.
The author of the US Food and Drug Administration’s Quality System Regulation – currently undergoing revision by the agency – says the upcoming new version of the rule should carry a brand-new name.
Kim Trautman says the FDA should consider renaming its updated QSR the “Quality Management System Regulation.”