The US Food and Drug Administration (FDA) asserts that it is on track to release a final rule this December that harmonizes the agency’s decades-old Quality System Regulation (QSR) with international standard ISO 13485:2016. Despite that deadline being roughly eight months away, it’s never too early for industry to prep for its arrival, two longtime experts say.
The FDA released its draft Quality Management System Regulation (QMSR) in February 2022; the agency had been busy combining the QSR with ISO 13485 since early 2018 (RELATED: QMSR: FDA proposes QSR overhaul after years of delays, Regulatory Focus 22 February 2022). The QMSR, when finalized, should be shorter in length than the QSR because the current regulation’s requirements are already “substantively similar” to what’s found in the quality systems standard from the International Organization for Standardization (ISO)…
