Experts: Don’t expect FDA’s QMSR to spur new regulatory jobs

Many device makers, particularly smaller ones, will likely make use of consultants and temporary employees when implementing a forthcoming final rule from the US Food and Drug Administration (FDA) that harmonizes the agency’s Quality System Regulation (QSR) with ISO 13485:2016, industry experts say.

Further, do not count on full-time regulatory or quality jobs being created because of the FDA’s soon-to-be-finalized Quality Management System Regulation (QMSR), said Smith & Nephew’s Vincent Cafiso, an ex-FDA staffer who is currently senior director of regulatory compliance & global audit at the device firm.

“I think what most companies will do is, they will bring in a consultant on the front end, for the education piece [and] the gap-assessment piece–even creating a quality plan to say, ‘Here's what you should be doing,’ and then leave that company, and then the company will take that and run with it,” Cafiso said in an interview with Focus.

FDA released its draft QMSR in February 2022; the agency had been busy combining its QSR with international quality systems standard ISO 13485 since early 2018. The FDA asserts that it is on track to release a final QMSR rule this December. (RELATED: QMSR: FDA proposes QSR overhaul after years of delays, Regulatory Focus 22 February 2022)

Aside from hiring a consultant—or consultants—Cafiso believes it makes sense for manufacturers, especially those who are not accustomed to working with the current FDA QSR or ISO 13485, to use temps to work through any document changes that must be made as they shift from QSR to QMSR.

“Most of the document changes aren’t going to be highly technical, they’ll be basically quality-system-type wording changes. And then those temps would probably be on for a year or so depending on how much needs to change, what needs to happen, what training needs to be done,” he said.

Next, “the company could then … either do its own audit cycle for the year after it implements, or bring that consultant back and say, ‘Hey, we did everything you said; audit us over the next three months, or year, or whatever. And then tell us how we did,’” Cafiso said. “But unless the company has huge pockets, I do not think they are going to have a consultant do it from start to finish. I think it is going to be a combination.”

Mac McKeen, adjunct professor at the University of Minnesota, who instructs a graduate-level course on medical device regulatory and quality, agreed with most of Cafiso’s assessment.

“As for the QMSR effort for regulatory and quality staff, I would think this could be absorbed mostly by existing staffing, as ISO 13485 and the current QSR Part 820 are about 80% aligned,” McKeen told Focus.

Because the FDA’s draft QMSR rule maintains specific requirements from the QSR and harmonizes the rest, “current quality systems are largely built for this next logical step,” he said. However, “I would anticipate some level of consultants being called in, more so for small companies.”

And, McKeen said, “as with any new and ongoing regulatory requirement imposed on industry, [a final QMSR] will need to be accompanied by a robust training program to effectively train staff on the updates to the regulation and requirements, and to document the training.”

Will firms with EU MDR experts on staff use them for FDA’s QMSR?

Cafiso pointed out that the upcoming final QMSR rule won’t be as heavy a lift as the EU’s Medical Devices Regulation (MDR), which was recently extended a second time amid concerns about notified body capacity and impending device shortages. (RELATED: Council votes unanimously to extend MDR deadlines, Regulatory Focus 7 March 2023)

The QMSR will not be “anywhere near as big as EU MDR,” Cafiso said, noting that Smith & Nephew created an EU MDR department and spent “millions and millions of dollars a year” for the past three years or so to make sure the company complies with the regulation. He said the device giant’s money went toward “MDR assessment, remediation, tracking, submissions, … labeling changes, [and] the impact of product that has already been labeled with different CE Marks,” among other activities.

Cafiso further explained that, unlike the MDR, the QMSR will not present a “product-impacting situation.” The deadline for transitioning to the new MDR regulation had been May 2024, but the European Commission voted in February to extend the transition time for Class III devices and Class IIb implantable devices to December 2027. And makers of Class I, Class II and Class IIb non-implantable devices now have until December 2028 to comply.

“Right now, as the EU MDR starts to go to the end of the line, companies like mine, we have EU MDR people who left their quality jobs or regulatory jobs to go work in this temporary three-to-four-year period of time [for the MDR], but now they do not have a job waiting for them,” Cafiso said. “So, they're kind of looking within the organization and saying, ‘Hey, I want to come back to Quality. Is there anything open?’

“We may lose some really, really good people to this,” he added.

McKeen said MDR resources put in place by larger firms, like Smith & Nephew, could be used to ensure compliance with a final QMSR rule. “Medical device companies currently have staff working on MDR implementation, [and] the timing of the QMSR is coincidental with this, so the MDR resources and teams can be transferred to take on this work, as it is certainty related,” he said.

“That could be the nirvana for some companies in that position,” McKeen noted. “Not that the FDA intentionally timed it that way—but it does overlap.”

Experts: Don’t expect FDA’s QMSR to spur new regulatory jobs

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