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Riding the wave of the new Quality Management System Regulation

Written By: Mark Swanson, Partner, CEO

Having just returned from the MD&M West Conference in Anaheim, CA, it was interesting to hear what the individual thought leaders are saying about the draft FDA rule that will update the Quality System Regulation (QSR). Once adopted it will become the ‘new’ Quality Management System Regulation (QMSR) in 21CFR820 and 21CFR4. In working as part of the Association for the Advancement of Medical Instrumentation® (AAMI) committee Working Group 1 (Application of Quality Systems to Medical Devices -WG01), we helped create the comparison document mapping 21CFR820 to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems, (Technical information report TIR102), so we are well versed in the similarities and differences.

With our experience with TIR102, we were given the opportunity to provide a short, 5 minute, pre-recorded input for consideration during the March 2022 FDA panel review session. The information presented at the meeting can be found here: Good-manufacturing-practice-advisory-committee-meeting-event-materials. Comments on the topic are due to FDA no later than May 24th, 2022, and can be given here: medical-devices-quality-system-regulation-amendments.

Overall, we support this effort and believe it will provide the most benefit to the startup, small and medium sized manufacturers. It will allow them to focus efforts on being compliant to and implementing one singular QMS, which will hopefully result in faster to market scenarios.

At MD&M, our friend Kim Trautman and others pointed out the need for those in industry to ensure they review the new definitions within the draft rule including 15 definitions in 820.3 along with 3 more concepts in 820.15 that are meant to modify the 20 definitions in ISO 13485:2016 and the normative reference to ISO 9000:2015 (more than 200 additional definitions). Organizations should consider commenting on whether there is a legal basis for FDA to change these definitions or if they can let the harmonization with the ISO definitions prevail. Also note that all of these ISO definitions are conveniently available in the ISO Online Browsing Platform (

On the combination product side, the focus is also on definitions and the changes that are introduced by the harmonization effort as it also affects 21CFR4. In the past, there has been resistance in the pharmaceutical industry to use ISO standards, however with the EU MDR use of the phrase “state of the art” being understood to apply to standards (see Article 117), and the addition of standard use in 21CFR4, the manufacturers of those combination products will need to pay closer attention to these requirements.

As we brace for the tsunami of information and changes coming at us, we will be working hard to “ride the wave” so that we can provide you with as much information as possible. Contact QRx Partners at or 833-779-7278 for support, discussion, or information.


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