Quality Management System Regulation (QMSR): FDA Final Rule

OMEDtechNews & Events

The US Food and Drug Administration (FDA) issued the Quality Management System Regulation (QMSR) final rule on January 31, 2024.  This final rule of the QMSR will coordinate central components of a device manufacturer’s Quality Management System (QMS) making it more in line with other regulatory authorities worldwide.  This extensive regulation modifies the current good manufacturing practice (CGMP) requirements stated in the Quality System regulation found in 21 CFR 820 and “FDA is accomplishing this primarily by incorporating by reference the 2016 edition of ISO 13485.” (1) ISO 13485 is a standard for medical devices and quality management systems. This new rule will take effect in 2 years on February 2, 2026.

FDA Final Rule Update Quality Management System Regulation

This new regulation will encourage uniformity in the regulation of devices. Over time, this will provide patients with more effective access to medical devices. The alignment with other regulatory authorities will expedite the introduction of high-quality, safe, and efficient devices available for patients.  Eventually, the Quality Management System Regulation will also lower industry training costs because internal training will now be able to cover a more uniform set of requirements.

The FDA encourages all parties in the medical device sector to become acquainted with the specifics of the QMSR Final Rule. Manufacturers can then take the required steps to be in compliance by the effectiveness date of February 2, 2026.  During the transition to the QMSR, manufacturers must abide by the QS regulation until the rule takes effect.  Manufacturers will need to address changes to their current quality management system procedures, quality agreements, or other documentation referencing the QSR.  During this phase, OMEDtech can help with questions and with the transition to the new QMSR. 

(1) Final Rule, Medical Devices; Quality System Regulation Amendments, 89 Fed. Reg. 7496 (Feb. 2, 2024)