Image courtesy of Stuart Miles at FreeDigitalPhotos.net
By Eric Thorn, Esq
Beginning back in the spring of 2018, FDA announced its intent to adopt rules to replace the current quality system regulations (QSR) found in 21 CFR Part 820 with rules more aligned with International Organization for Standardization (“ISO”) standard ISO 13485:2016 (ISO 13485). This year, on February 23, 2022, FDA published a proposed rule for comment. The comment period ended on May 24, 2022 and the FDA is now in the process of reviewing and addressing the comments received and considering which suggested changes to include in its final rule.
ISO 13485 is an international standard and is the most common way for medical device manufacturers to establish compliance with the Quality Management System (QMS) requirements in Canada, Europe, and Australia, and also serves as the basis for QMS compliance in Japan, Korea, and Brazil. It is important to note that while the new QMSR are aligned with ISO 13485, the new QMSR does not require full ISO 13485 certification. This is good news for labs because full ISO 13485 certification requirements combined with the annual audit requirements can be costly.
While no publication date has been announced, it is anticipated that the FDA will publish its final rule in the early half of 2023, or sooner. The final rule will replace the current QSR and the new rule will be referred to as the Quality Management System Regulation (“QMSR”). FDA proposes to make the QMSR effective one year after the publication date of the final QMSR rule in the Federal Register.
Depending on the size of lab and how fully your lab has implemented current QSR regulations, becoming QMSR compliant could take a few months or more based on laboratory size and the number of devices being manufactured. This is partly why FDA will not make the QMSR effective until at least one year after the date of publication of the final rule.
While some of the QMSR requirements will be new, since much of ISO 13485 is well aligned with the FDA’s current QSR requirements, those labs that have a fully implemented QSR will already be most of the way there. Identifying the differences now will allow you to undertake a methodical transition over time. If your laboratory is in the process of setting up or implementing quality systems, clearly you will want to implement a quality management system that will meet the new QMSR requirements.
For a discussion of how the provisions of ISO 13485 compare with the currently applicable quality system regulations of 21 CFR Part 820 and a comparison table of the two, please see: https://www.greenlight.guru/blog/iso-13485-2016-iso-13485-2003-fda-21-cfr-part-820