Experts: Expect QMSR to spawn cottage industry of consultants over next two years

Experts say the US Food and Drug Administration’s (FDA) finalized Quality System Management Regulation (QMSR) will likely lead to a cottage industry of consultants to help medtech manufacturers navigate the new regulatory requirements. While large multinational companies with internal regulatory teams may be able to pivot to the new requirements quickly, smaller companies will likely need outside help.

On 31 January, FDA published its long-anticipated QMSR final rule with a two-year transition period. The rule harmonizes the agency’s Quality System Regulation (QSR) with the International Organization for Standardization’s (ISO) widely recognized ISO 13485:2016 standard (RELATED: FDA issues QMSR final rule with 2-year transition period, Regulatory Focus, 31 January 2024).

On a fundamental level, FDA’s current QSR regulation parallels the ISO 13485 standard, which multinational medtech manufacturers are well-versed in, Philip Desjardins, a partner at the law firm Arnold and Porter, said in an interview with Focus. He said that regulators outside the US, especially the European Medicines Agency (EMA), have been using different standards, including ISO 13485, and about five years ago FDA realized that it would benefit everyone if they adopted the standard.

“This harmonization is a huge win for those organizations that are working in multiple jurisdictions,” said Desjardins, a former vice president for global regulatory affairs at Johnson & Johnson. “It doesn't take away any of their regulatory or quality responsibilities, but what it does is allows them to simplify, allows them to … point toward a single standard.”

Desjardins added that manufacturers will have to update their procedures to comply with the QMSR, but ultimately, the effort is worth it because it will streamline their work and reduce administrative burdens. He also noted that FDA will likely need to update its procedures and provide training to staff to ensure compliance with the new system.

Keisha Thomas, associate director for compliance and quality at the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH), said that one of the most important takeaways for industry regarding QMSR is that the requirements are substantively similar to what was expected of them under the QSR regulation. Manufacturers still must prove the consistency of their quality oversight, and that their products continue to be safe and effective, she said in an interview with Focus (RELATED: FDA compliance chiefs detail FY2023 trends, plans for FY2024, Regulatory Focus, 7 December 2023).

"I think it's really important for manufacturers to understand that the scope and the interpretation of the quality management system regulation is unchanged from that of the quality system regulation, so it applies to the same groups of manufacturers that the quality system regulation did, and the way we interpret the requirements is fundamentally unchanged," she said.

Thomas added that the most significant difference manufacturers may notice under QMSR is that it is more explicit than the QSR regulation in integrating risk requirements since the text of ISO 13485 is also more explicit.

"I want it to be clear that this is not a new expectation for FDA," she added. "We've always expected that risk management be integrated and utilized throughout the quality management system."

Myriad FDA documents, including guidances, regulatory provisions, and internal directives, reference the current QSR regulations and will need to be updated to reflect the new QMSR system, according to Steve Silverman, president of The Silverman Group, a consultancy. Updating the agency’s internal communications and training processes to address the new regulation will also be a challenge.

“It’s hard to overstate how significant and labor-intensive this process is going to be, which is why I’m pleased that the FDA has reconsidered its transition timeline and adjusted it from the one-year timeframe to a two-year timeframe,” said Silverman. “There will need to be very comprehensive and demanding changes both to FDA documentation and practice.”

Despite the challenge, Silverman, a former compliance director at CDRH, told Focus that he’s confident the agency will be able to come up to speed on how to work under the QMSR by the time it comes into effect.

Thomas said that FDA has been working on implementation activities, including updating their information systems and training staff responsible for compliance with QMSR requirements. She noted that the agency will use the two-year timeframe to conduct those activities.

"The agency is going to be developing a new inspection process, conducting revisions and updates to impacted and relevant documents such as [standard operating procedures (SOP)], work instructions, and regulations,” she added.

As for manufacturers, Silverman said that the medtech industry is diverse, and while larger companies will likely be well-prepared for the change, smaller companies will need a lot of help figuring out how to navigate the new system.

“I predict that there is going to be a cottage industry formed of people out in the marketplace telling the entire medtech community that they can explain what they need to know to prepare for this transition,” said Desjardins.

Desjardins added that the implementation of QMSR reminds him of the early stages of the EU Medical Device Regulation (MDR), which is replacing the former Medical Device Directive (MDD), where the European regulators and regulated industry often learned how to work under the regulation together. Similarly, he cautioned that industry should keep in mind that as FDA implements QMSR, agency officials may be figuring out how to comply at the same time as they are.

"I wouldn't be surprised that between now and two years from now, there may be mock audits and mock inspections that are still real inspections that will be held to the standards of the old Part 820, but the auditors themselves may be running analyses through the future ISO 13485 standard," said Desjardins. "I think this is a real opportunity for all manufacturers to think through how do they work through and work with that inspectorate during that transition so that that individual company can learn, the FDA organizations, both the inspectorate and the center itself can learn, but also industry as a whole can learn."

Silverman noted that the transition to QMSR could be made more challenging by the agency’s proposed reorganization of the Office of Regulatory Affairs (ORA). The agency recently announced that it had sent its reorganization proposal to the Department of Health and Human Services (HHS) for approval. If approved, the plan would mean significant staffing and operational changes to how the agency conducts investigations and inspections (RELATED: FDA leaders detail reorg plans, say 1,500 ORA staff will be reassigned, Regulatory Focus, 19 January 2024)

“At the same time that FDA is identifying new information about its compliance activities and commodity oversight, it's going to be communicating with a field organization that is fundamentally changing its mission and shrinking the staff who are responsible for performing that mission,” said Silverman. “I don't think that those changes will prevent or impair this transition, but there is no doubt that they will make this transition more complex because of, among other reasons, a large part of where ORA's attention is going to be in coming years.”

Desjardins said he is most concerned about how smaller manufacturers will adapt to the new regulatory system and that stakeholders must ensure their voices are heard. As manufacturers start adapting and having conversations with FDA about the transition, he said he’d like to see the conversation focus on how small companies are struggling and what can be done to help them. That conversation should evolve based on the needs of various stakeholders.

Silverman said the transition is also a unique opportunity for medtech trade associations to play a role in helping industry come up to speed. He noted that while FDA's job is to train its own staff, it’s up to the industry to ensure all companies have the training and resources they need. He added that trade associations have an opportunity to launch initiatives to ensure companies have the resources they need and can create training modules that FDA can provide feedback on without endorsing them.

“FDA can provide this training, trade associations will provide this training, but there will be for-profit organizations that will stand up and say, 'Listen, I have implemented changes from existing Part 820 to ISO 14385 in organizations of your size that manufacture similar products,’” Desjardins added. “There will be stand-alone experts where this will become their expertise, and they will be very valuable across the industry for organizations of varying sizes.”

While Desjardins and Silverman are concerned that smaller companies may face a more significant challenge conforming to the new regulatory system, Thomas is not as concerned.

"Considering that the requirements are substantively similar, I don't anticipate that there is likely a difference in a company meeting the requirements that are in the quality management system," she said.

When developing the QMSR rule, Thomas said the most difficult task for the agency was striking the right balance between ensuring they were adhering to and aligning with ISO 13485 requirements and meeting the FDA's preexisting statutory requirements. Ultimately, she expects it will reduce redundancies and better align requirements across regulatory regimes, which she thinks will likely be seen as a positive by industry.

"I think there are benefits beyond just duplication reduction in harmonizing requirements this way," she added. "I think it will have an impact on getting products to market faster and helps remove barriers to patient access when you've got an individual set of aligned requirements."

Thomas noted that there have been conversations about what would happen with QMSR if the ISO 13485 standard is revised in the future. FDA would evaluate any such changes and assess whether the rule needs to be amended at the time, she said.

"This is an exciting time for transitioning quality management system requirements as a whole. We're very proud of what we've achieved in finalizing this rule,” she said. "We think it will benefit industry and our stakeholders as a whole and that industry in general will be better for it."

Experts: Expect QMSR to spawn cottage industry of consultants over next two years

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