On February 2, the FDA published the Quality Management System Regulation (QMSR) Final Rule on its official website, amending the current Good Manufacturing Practice (GMP) requirements of the Quality System Regulation (21 CFR Part 820) by incorporating ISO 13485:2016 by reference.
This represents a very important step towards greater harmonisation of US regulations with the international context. Specifically, the law brings US Medical Devices quality management requirements closer to those of other markets such as the European Union, Japan and Australia, where quality standards are primarily based on ISO 13485:2016.
The law will come into force on February 2, 2026 and, therefore, manufacturers have two years to align internal processes and procedures, make appropriate changes within their organisations and update documentation according to the requirements of the QMSR Regulation.
However, the FDA confirms that compliance with ISO 13485:2016 alone does not fully meet the requirements of the QMSR Regulation and has included additional requirements to be met in addition to ISO 13485:2016 in the law. For example, the FDA argues that ISO 13485:2016 does not specifically address the inspection of labelling and packaging by the manufacturer, and consequently, the requirements of the QMSR Regulation that strengthen controls for labelling and packaging operations are retained in the law.
Furthermore, the FDA does not currently oblige manufacturers to show management audit logs, internal quality audit reports and supplier audit reports to inspectors. However, it removed this exception in the latest law because it considers that it does not apply to manufacturers inspected by other regulatory bodies or audited by other bodies such as, for example, Medical Device Single Audit Programme (MDSAP) audit organisations.
In conclusion, FDA intends to align the US regulatory framework with that of other countries around the world to promote regulatory compliance of devices and provide a faster introduction of safe, effective, high-quality devices for US patients.
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