QMSR: Industry wants to avoid ISO 13485 ‘plus,’ seeks longer transition period

Regulatory NewsRegulatory News | 02 March 2022 |  By 

Industry representatives and members of the US Food and Drug Administration’s (FDA) Device Good Manufacturing Practice Advisory Committee (DGMPAC) embraced the agency’s proposal to align US quality system requirements with ISO 13485 but cautioned against adopting too many US-specific requirements and stressed that a one-year transition period is too “aggressive” for industry.
Participants also asked for clarity around ISO 13485 certification requirements and expressed concern about the agency’s approach to “hardcode” the current 2016 version of the international standard into the US regulation.
The comments were made during a full-day meeting of the DGMPAC on Wednesday to review FDA’s proposed rule to align the Quality System Regulation (QSR) found in 21 CFR Part 820 with ISO 13485:2016. The resulting regulation would be known as the Quality Management System Regulation (QMSR). (RELATED: QMSR: FDA proposes QSR overhaul after years of delays, Regulatory Focus 22 February 2022)
FDA presentation
While the QSR was “flexible enough to cover the multitude of devices” regulated by FDA, Melissa Torres, associate director for international affairs at the Center for Devices and Radiological Health (CDRH), said that ISO 13485 represents a more modern QMS approach and “has greater integration of risk management activities and stronger ties to ISO 14971, the risk management standard for medical devices.”
Torres noted that the requirements of ISO 13485 are “about 90-95% similar to those in the Quality System Regulation.” She also clarified that the agency would retain its inspectional authority and that FDA inspections “will not result in certificates of conformance to ISO 13485 and manufacturers who have ISO 13485 certificates are not exempt from FDA inspections.”
Aside from the changes the proposed rule would make to 21 CFR Part 820 and FDA’s quality system inspection technique (QSIT), Torres pointed out that many other regulations and guidance documents that reference Part 820 would need to be revised as well.
Keisha Thomas, deputy office director of CDRH’s Office of Health Technology 1, gave an overview of some of the differences between the QSR and ISO 13485, noting the international standard’s “greater emphasis on risk management activities.” She said that while “some may see this more explicit, more prescribed regulatory requirement as different than what was in the Quality System Regulation but … there has been an expectation from FDA all along that risk management activities be considered throughout the total product lifecycle, even though that requirement was not explicitly called out” throughout the QSR.
Industry seeks longer transition period
Representatives of two industry groups, the Advanced Medical Technology Association (AdvaMed) and the Medical Imaging and Technology Alliance (MITA) presented during the hearing, and while both groups praised agency’s proposal, each raised questions about its implementation.
Jamie Wolszon, vice president, technology and regulatory affairs at AdvaMed, said the group “strongly supports” the proposed transition and outlined a number of perceived benefits, including reduced barriers to trade and the elimination of the need for device makers to maintain multiple quality systems.
However, Wolszon emphasized industry’s interest in “avoiding a 13485 ‘plus’ type of approach,” in which FDA adopts “additional requirements over and above 13485 that are country-unique.”
She also stressed that the one-year transition period proposed by FDA would not give industry enough time to adapt to the new requirements.
“There must be a sufficiently long transition period to avoid disruption. We recommend at least a 2-year transition period,” Wolszon said, adding that the transition will be more challenging for smaller firms and companies that only sell medical devices in the United States. She noted that companies could choose to immediately implement the changes if they were able to do so.
The industry representatives on the committee concurred, with Robert Phillips, vice president, quality and regulatory at Siemens Healthineers, and Scott Sardeson, international regulatory affairs and quality compliance director at 3M, calling the one-year timeline “aggressive.” Phillips suggested that a two- or three-year transition would be more appropriate.
On inspections, both Wolszon and Diane Wurzburger, who spoke on behalf of MITA, asked FDA to clarify that ISO 13485 certification would not be required under the proposed rule.
“The reason this is important is that our small member companies have informed us that having to pay for an ISO 13485 certification could be costly and a potential challenge for them,” Wolszon said.
Additionally, Wolszon said that industry would like to see FDA harmonize its inspections with how other international entities, such as notified bodies, conduct audits and asked whether there would be any benefit conferred to device makers that have existing ISO 13485 certificates.
Some concerns were raised during the meeting regarding how FDA would handle future revisions to ISO 13485. Wurzburger said that FDA should consider the dynamic review cycle for ISO standards, which is typically 5 years, when settling on a timeframe for rollout.
Peter Linders, who chairs the ISO technical committee on medical device quality management (ISO/TC 210) tried to dispel the notion that the standard would be revised anytime soon. He said that there currently “no appetite whatsoever to revise ISO 13485.” Linders added it’s unlikely there will be any change to the standard or “even the beginning of a change until 2025.”
Phillips also asked, “whether it makes sense to hardcode 13485:2016 directly within the QSR language.” He said that doing so “potentially creates conflict down the road, not only with potential revisions to 13485,” but also with other programs, such as MDSAP, that use the standard.
Several panel members acknowledged that while FDA has expectation for risk management beyond what is explicitly called for in the QSR, the shift in emphasis on risk management might represent a challenge for smaller companies.
“It seems as though the spirit in the existing language [about risk management] is present for this to be equivalent. However, I don’t believe, based on the feedback we’re hearing today, that it is in practice, at least not in all organizations,” said Alisha Loy, quality and operations manager at the University of Iowa Hospitals and Clinics.
Gordon Gillerman, director of the Standards Coordination Office at the National Institute of Standards and Technology, questioned whether all the legacy requirements FDA is carrying over in the proposed rule are necessary.
“Are we just looking at the old standard and plugging in what’s not in the new standard? Or are we really looking at what’s necessary to fulfill our legitimate objectives here. I think it’s a really important eye that we have toward those legacy requirements from 21 CFR 820 that we don’t continue those requirements by adding them as ‘plus’ requirements or national differences or deviations, just because they existed in the regulation before. We make sure that they actually provide a contribution that’s worthwhile to patient safety and device effectiveness,” he said.


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