QMSR is coming. Are you ready?

FDA is expected to finalize the proposed Quality Management System Regulation in 2024. The revised regulation adds a heavy emphasis on risk in alignment with ISO 13485:2016.

It has been over 25 years since the last time the US FDA significantly amended the Quality System Regulation (QSR) under 21 CFR part 820. Medical device manufacturers are required to comply with the QSR in order continue marketing their currently approved or cleared products in the USA.

Coincidently, ISO also issued the first edition of ISO 13485, “Quality systems - Medical devices - Particular requirements for the application of ISO 9001” in 1996, the same year when the FDA proposed the final rule for revising the QSR to include requirements for pre-production design controls.

Since then, ISO has revised the ISO 13485 standard several times the most recent of which was published in 2016. ISO 13485:2016 is currently the state of the art international standard, which provides a framework to establish a Quality Management System (QMS) in alignment with internationally accepted best practices. In some jurisdictions, conformance with ISO 13485:2016 is required to comply with legally binding regulations.

The QSR, on the other hand, has not gone through any significant revisions after the 1996 proposed rule became effective on June 1, 1997. As a result, FDA’s regulatory oversight has lagged behind the rapidly evolving global regulatory environment.

This is about to change!

On February 23, 2022, the FDA issued a proposal to revise the current QSR into the Quality Management System Regulation (QMSR) to “align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world¹”. The public comment period is now closed, and the FDA is expected to finalize this proposed rule in 2024.

This is going to be a significant change for medical device manufacturers who are not already practicing the QMS requirements prescribed in ISO 13485:2016. One reason is the heavy emphasis on risk management throughout the QMS, which is now going to attract a high level of scrutiny by the FDA under QMSR, because it includes the requirements of ISO 13485:2016 through a normative reference.

Most likely, the FDA will allow a 1 year transition period after the QMSR becomes effective in 2024. Since there is a lot of overlap between QMS and risk management, we will be focusing on this theme on Let’s Talk Risk! this year to help you get ready for this transition.

This article is the first in a series of articles and podcasts we plan to share this year. In this article, we are focusing on the specific clauses of ISO 13485:2016 with explicit risk-based requirements. This is the first step in identifying potential gaps in your current QMS.