The US Food and Drug Administration (FDA) has published its long-awaited Quality Management System Regulation (QMSR) final rule that harmonizes its requirements with a widely recognized International Organization for Standardization (ISO) standard. The agency said the rule will ensure consistency in regulatory expectations for device makers across regulatory regimes, while saving industry hundreds of millions of dollars annually.
On 31 January, FDA published its QMSR final rule that has been years in the making. The rule amends FDA’s current medical device good manufacturing practice (CGMP) expectations under its quality system (QS) regulation to align with ISO 13485:2016…
