RAPS

QMSR: FDA proposes QSR overhaul after years of delays

Four years after the US Food and Drug Administration (FDA) signaled its intent to align its Quality System Regulation (QSR) with the international standard ISO 13485:2016, the agency on Tuesday issued ...
JD Supra

FDA (Finally) Harmonizes Medical Device Manufacturing Requirements With ISO

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Brendan Carroll, Jessica Ritsick, Jong Ho "Philip" Won, Ph.D. Our FDA: Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
RAPS

FDA Considers Shift on Device Quality System Regulations

A US Food and Drug Administration (FDA) spokeswoman told Focus on Wednesday that as part of global harmonization efforts around quality management systems, the agency is considering adding clauses ...