On January 31, 2024, the FDA introduced the Final Rule for the new Quality Management System Regulation (QMSR), set to replace the existing Quality System Regulation (QSR) to align with ISO 13485:2016, which is the international standard for medical device quality management systems. This alignment aims to standardize good manufacturing practice (cGMP) requirements globally, a move that has been anticipated since 2018. The enforcement of the QMSR will begin on February 2, 2026, giving medical technology companies some time to adjust to the new requirements.
The new QMSR integrates ISO 13485 by reference, modifying certain aspects of 21 CFR Part 820. The terminology used in the previous QSR will be changed to align with ISO 13485 terms, such as using ‘Medical Device File’ (MDF) instead of the previous terms device master record, device history record, and design history file. However, FDA will maintain its definitions over similar terms found in ISO 13485 to avoid inconsistencies with its regulatory framework, for instance, ‘device’ and ‘labeling’ as opposed to ‘medical device’ and ‘labelling.’
One significant addition is the new Section 820.45 in Part 820, focusing on the procedures for labeling and packaging of medical devices which aims to address issues frequently resulting in device recalls. This section emphasizes the need for detailed procedures to ensure the integrity and accuracy of labeling and packaging processes.
ISO 13485 has undergone several revisions to ensure it remains up-to-date with the international regulatory environment, with its latest validation in 2020. FDA’s decision to incorporate ISO 13485 by referencing it within QMSR is to sync with the currently recognized international regulatory expectations for quality management systems. This integration not only aims at regulatory simplification but is also intended to alleviate the industry’s burden, making device market access more efficient.
For medical device manufacturers, this alignment means that while they might not need to overhaul their current quality management systems entirely, they will need to make certain adjustments to comply with the new regulations. Key to note is that even if a company is already ISO 13485:2016 certified, this does not exempt it from FDA inspections under the new QMSR, and such certification will not be considered as a direct compliance pass during FDA reviews.
Additionally, the Final Rule has also made amendments to 21 CFR Part 4 regarding the regulation of combination products, with “conforming edits” to clear up the QMS requirements for these products. These changes, however, do not alter the cGMP requirements for combination products.
The FDA is also planning to revise its inspection process to ensure consistency with the new QMSR, although specific details on the changes to the inspection process have yet to be disclosed.
Medical device companies should begin preparing now by familiarizing themselves with the new requirements and considering how to integrate them into their current systems, even if they are already in line with ISO 13485 standards. Compliance with the new QMSR requires understanding and implementing the specific changes, particularly in areas of documentation and process specifications governed by the adjustments within the rule.
To aid in the transition, resources such as the FDA QSR, QMSR & ISO 13485:2016 Internal Audit Checklist are available to help companies audit their current systems against the new standards.
For organizations looking to update their existing quality management systems, solutions like Greenlight Guru’s eQMS, which are designed specifically for the MedTech sector and built to comply with FDA and ISO standards, can facilitate a smoother transition to compliance with the QMSR. Greenlight Guru offers MedTech companies a purpose-built QMS solution that not only meets regulatory expectations but also aids in maintaining a state of continuous compliance, thereby simplifying the quality management processes.
In conclusion, as the medical device industry progresses towards global regulatory harmonization, the FDA’s QMSR signifies a substantial evolution from the traditional QSR, embracing international standards to promote regulatory efficiency and reduce burdens on the industry, ultimately accelerating patient access to essential medical devices.
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