FDA goes 13485 – say hello to QMSR!

February 26, 2024

Finally! On January 31, 2024, the FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference, ISO 13485:2016.

Medical devices – Quality management systems

The final decision was presented four years after FDA announced their intention to perform a revision of the regulation, the first one since 1996. The rule is effective February 2, 2026. Until then, manufacturers are required to comply with the QS regulation.

– So, why is this done?

FDA wants to promote consistency in the regulation of devices and have determined that the requirements in ISO 13485 are ‘substantially similar’ to the requirements of the QS regulation, providing a corresponding level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective.

– What is the impact?

Will ISO13485:2016 certification be sufficient to demonstrate compliance with QMSR? No, there are additional requirements in the regulation that the manufacturer must comply with, such as those regarding control of device packaging and labeling. Consequently, an audit against the standard does not replace an FDA inspection.

Register now!

– Can an approved FDA inspection be used to demonstrate compliance with the standard? Are manufacturers of components and raw materials for medical devices in scope? Join our upcoming webinar, March 20, where these and many other questions are answered!

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