Finalizing the Quality Management System Regulation – A High Priority for End of 2023

Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda.

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here). According to the Unified Agenda, the proposed rule is in the final rule stage.

The final rule’s publication is a “high priority”, according to Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), during his remarks at the annual Food Drug and Law Institute (FDLI) conference in May 2023. In fact, the priority designation for the final rule is labeled as “economically significant.” Dr. Shuren further elaborated that he hopes the final rule will be “out by the end of this year.” This would align with the timeline in the Unified Agenda which identifies December 2023 as the expected publication date for the final rule.

We remain cautiously optimistic of the timeline given the extensive and competing priorities CDRH has in front of them, including:

• implementing provisions required under the Food and Drug Omnibus Reform Act (FDORA) (which we summarized and analyzed here),
• meeting performance goals set forth in MDUFA V,
• working on their 2022 – 2025 strategic priorities,
• realizing the transition of Emergency Use Authorizations to premarket submissions, and
• possibly working on a proposed LDT rule making (see our earlier post on this new development here).

Even if the teams are different for each of these activities, freeing up resources to finalize the rule, it is still a significant undertaking in the next six months.  While the proposed rule contemplates a transition period of one year to allow for this, commenters to the proposed rule think two to three years is more appropriate. We will not know the official transition period until the final rule has been published.  However, two to three years seems far more appropriate even from FDA’s perspective.

Once the final rule is published there will still be significant work to be done by FDA.  For example, during the transition period, FDA would need to address the effect of the new regulation to the existing inspection process and staff would need time for training to effectuate execution and enforcement.  Finally, CDRH would need to ensure alignment on existing guidance documents and regulations that refer to the QSR or 21 C.F.R. Part 820.

Time will tell if the rule can be finalized by year’s end and how much time both FDA and industry will have to prepare for its effect.  Those in industry who are already ISO 13485 and QSR compliant and participating in FDA’s Medical Device Single Audit Program are likely the most well prepared and will feel the least impact by the change.