CDRH hopes to release the QMSR final rule later this year. Here’s why we’re skeptical.

The Quality Management System Regulation (QMSR) and timing.

• QSR, QMSR and ISO 13485: The current medical device quality system regulations (QSR) are U.S.-specific. Outlined at 21 CFR 820, they set regulatory standards for facilities and controls for medical device manufacturing, packaging, storage, and installation.
• However, outside of the U.S. regulators have been converging around an international quality system standard, ISO 13485. For several years, the FDA has been working to harmonize its QSR with ISO 13485 in order to foster consistency for regulated industry and global quality expectations for medical devices.
• In February 2022, after years of discussion and background work, the FDA published a proposed rule that would “incorporate by reference” the 2016 version of the ISO 13485 quality standard into the agency’s regulations, replacing the QSR with a new Quality Management System Regulation (QMSR) that leverages ISO.
• This move had been a long time coming. FDA’s Center for Devices and Radiological Health (CDRH) announced its intent to transition from the QSR to the ISO standard back in May of 2018, the planned regulation has been delayed several times. The agency’s original projected publication date for the proposed rule to effectuate the transition was April 2019, which was later pushed back to October 2020, a target date that again was not met. While the 2021 Unified Agenda, a federal resource that lays out the regulations different federal Departments and agencies are looking to publish on projected timelines, of planned rulemaking listed the target date as June 2021, CDRH Director Jeff Shuren later stated in May 2021 that his goal was to get the proposed rule out by the end of that year. In August of 2021, the agency started to prepare some of its staff for the impending transition – albeit without a formal regulation. The proposed rule itself was published (as mentioned above) in February 2022; The FDA held an advisory committee meeting on the subject later that year, but has not provided additional updates on the transition since.
• CDRH Director Shuren has had limited things to say about a final rule. In particular, Shuren answered questions about the final rule at the recent Food and Drug Law Institute (FDLI) conference; AgencyIQ would note that his references to the QSR/QMSR were all directly in response to questions, rather than part of his prepared remarks. As AgencyIQ previously noted, when questioned on the subject, Shuren noted that the final rule was a “high priority” and that he hoped the final rule would be out by the end of the year, but deferred on a timeline to the eventual publication of the Spring 2023 Unified Agenda, which would be expected to have a proposed (if nonbinding) timeline for the rule’s publication.
• In fact, here’s exactly what he had to say. In response to whether the final QMSR rule would be out by the end of 2023, Shuren said: “That is a high priority, and it is our hope that it is out by the end of this year. Right here, first, folks.”

While it’s undoubtedly true that QSR harmonization is a high priority for the agency, and that Shuren would “hope” that the policymaking moves quickly, there more than a few reasons to be skeptical of this potential timeline.

• First, let’s take a look at the Unified Agenda. The Unified Agenda is the list of regulations that federal Departments and agencies have planned and potential (albeit nonbinding) timelines for their release. The Unified Agenda is published twice a year, in two versions (Fall and Spring), although the titles have limited connection to their actual timeline for publication; for example, the current edition is the Fall 2022 Unified Agenda, which was published in January 2023. In that version of the Agenda, FDA did move the final QMSR rule from a “long-term action” (i.e., something without a defined date) on to the Agenda list with a targeted publication date of December 2023.
• However, as AgencyIQ noted at the time, we would not be surprised in the slightest if this date of publication is pushed back given the enormity of FDA’s policymaking to-do list this year, but it does give the agency something to strive for – which Shuren echoed at FDLI.
• The process for publishing a rule is also extensive: Once the FDA has finished writing a rule, the agency must submit it for review by the Office of Management and Budget’s Office of Information and Regulatory Affairs (OMB, OIRA). Such reviews generally take weeks (at a minimum) – and occasionally many months. While more significant actions tend to have longer review periods, the proposed rule was only under review for about a month (January to February 2022). That said, industry will have some lead time to plan once the rule lands at OIRA. The proposed rule included a two-year transition period, which FDA advisors unilaterally noted would likely be insufficient, but the overall timeline remains to be seen. AgencyIQ would note that the FDA does not have any say in how long these reviews take.
• When will the Spring 2023 Unified Agenda be published? It’s hard to say. OIRA is also responsible for the compilation and publishing of the Unified Agenda twice a year. “Every spring is the next Unified Agenda,” Shuren said at FDLI.” And so, I know OMB, OIRA’s actively engaged on that, and then hopefully sometime in the near future that will be out there, and then they’ll have their list” of rules. However, Shuren deferred on providing a date for publication of the final rule besides pointing to the Unified Agenda for a proposed timeline (for the proposed rule) and saying that he “hoped” the rule would be out this year.
• Some operational notes about CDRH’s preparation for big policy changes. The transition to the QMSR would be an extremely heavy lift for CDRH operationally, including internal trainings for staff (or re-trainings), the need to build a new inspections process based on the new system (replacing the Quality System Inspection Technique (QSIT), and then training all inspections staff on that system) and adjust all existing regulations, guidance documents and policies that refer to “21 CFR 820” or QSR – all key areas of concern at the 2022 advisory committee meeting on the proposed rule. That said, there’s likely never a good time to launch on such a project, but the back half of 2023 seems like a particularly bad time, especially given the still-outstanding expected transition away from the emergency authorities for the Covid-19 pandemic. Further, AgencyIQ would note CDRH’s ongoing challenges with hiring, with Shuren recently acknowledging that the Center will need to take a different approach to its training and onboarding processes to better align with the modern workforce. CDRH will need a significant amount of lead time, staff capacity and organizational/operational planning in order to effectuate the QMSR policy transition.
• And then there are the things outside of FDA’s control. For example, it’s possible that the government could experience a shutdown this year if Congressional Republicans and Democrats are unable to reach a deal on funding the government after this fiscal year. Such shutdowns can last weeks, and would leave FDA unable to work on its policy priorities during that time.
• The bottom line: While it’s possible that the final rule will be out in the next 6 months, AgencyIQ believes that this is unlikely. Given the rest of CDRH’s to-do list for 2023, which includes implementing provisions required under the recent Food and Drug Omnibus Reform Act (FDORA), building out programs and issuing new or revised policy under MDUFA V, working on its pre-market review improvement projects (which are tied to its “Strategic Goals”) and effectuating the Covid-19 emergency use transitions – all of which have more concrete anticipated timelines than the QMSR transition –AgencyIQ would think that the Center has its hands full. However, CDRH has been working on the policy for (literally) years, so it’s always possible that the policy is rather far along – and therefore could be published with a transition timeline that would make the policy workable for both regulators and regulated industry. Shuren’s remarks at FDLI, that the rule is a high priority and he hopes to have it out soon, notably echo his remarks in 2021 in which he said the proposed rule “will happen this year” (the proposed rule was published the following February) but also cited the complexities presented by the Covid-19 pandemic.

To contact the author of this item, please email Laura DiAngelo.
To contact the editor of this item, please email Alexander Gaffney

Key Documents and Dates

• What’s new at CDRH: Device policy updates from FDLI
• At MDMA, FDA leadership spells out priorities in medical device policy