FDA: Medical Devices – Quality System Regulation Amendments
The US Food and Drug Administration (FDA) has released its Quality Management System Regulation (QMSR) final rule after years of development. It is a rework of the Quality System Regulation (QSR) – 21 CFR Part 820.
This rule aligns FDA's medical device good manufacturing practice (CGMP) expectations with the widely recognized ISO 13485:2016 standard, aiming to harmonize regulatory requirements for device manufacturers globally.
In adopting ISO 13485, the QMSR incorporates risk management throughout its requirements and explicitly emphasizes risk management activities and risk-based decision making as important elements of an effective quality system. The FDA states that this move will enhance consistency in regulatory expectations and save the industry significant costs.
Manufacturers have until February 2, 2026, to comply with the new rule, with the option to adhere to current requirements until then.
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