10 Takeaways from the FDA’s QMSR Medical Device Companies Should Be Considering Now
10 Takeaways from the FDA’s QMSR Medical Device Companies Should Be Considering Now
The QMSR will become effective in less than two years. Here are a few things to start thinking about — if you haven't already.
We recently published a brand new QMSR white paper and gap analysis worksheet that is available to paid subscribers.
Today, we’d like to step back and look at the regulatory revisions themselves.
In case you need a quick refresher, back in February, the FDA published a final rule amending the current good manufacturing practice requirements for medical devices. The amendment harmonizes the existing requirements with ISO 13485:2016. The revised requirements will now be known as the Quality Management System Regulation (QMSR).
The FDA’s final rule, which introduces the QMSR, closely aligns with a proposed rule issued a year earlier in February 2022. The FDA determined that ISO 13485:2016's requirements are substantially similar to the existing Quality System Regulation (QSR) in 21 CFR Part 820 and provide a comparable level of assurance that devices are safe, effective, and compliant with the FDCA.
To reduce the regulatory burden on global device manufacturers who must comply with both the QSR and ISO 13485, the FDA is amending Part 820 to replace the QSR with the QMSR, which incorporates ISO 13485:2016 by reference. The QMSR also includes additional definitions and requirements to clarify certain expectations and avoid potential inconsistencies with the FDCA and other applicable FDA regulations.
While there’s a lot to parse here, we thought we’d start with a high-level summary of the biggest takeaways that professionals need to consider as they prepare to comply with the updated regulations.
1. The QMSR will be effective in less than two years from now
The QMSR will become effective on February 2, 2026. Until then, device manufacturers must continue to comply with the existing QSR. Although the proposed rule suggested a one-year transition period, industry stakeholders expressed concerns that this timeframe was insufficient for training personnel, revising procedures, and updating practices.
In response, the FDA extended the transition period to two years for all device manufacturers. No additional time has been granted for small or midsize companies.
2. The QMSR’s scope remains consistent with the QSR
Specifically, the QMSR will apply only to manufacturers of finished medical devices, mirroring the QSR’s applicability. The FDA considered extending the QMSR requirements to manufacturers of device components or parts but ultimately decided against it. However, the agency noted that it has the legal authority to do so under the FDCA.
Also, the QMSR will not extend to third-party servicers and refurbishers, maintaining the same scope as the current QSR. This decision underscores the FDA’s intent to align the new regulation closely with the established framework while modernizing and internationalizing key aspects.
3. A few QSR-specific terms are going away
With the adoption of ISO 13485:2016, many terms that are specific to the QSR will be phased out. The FDA has decided to eliminate terms such as “design history file,” “device manufacturing record,” and “device history record” because ISO 13485 includes analogous requirements that serve the same purpose.
For example, the “design and development file,” as described in ISO 13485, is seen as equivalent to the QSR’s design history file. Similarly, the “medical device file” required by ISO 13485 encompasses the records previously covered by the device master record under the QSR. This shift in terminology is part of the broader effort to streamline and harmonize the regulatory language, making it easier for manufacturers to comply with both U.S. and international standards without redundancy.
4. Management reviews and internal audit reports will no longer be exempt from FDA inspection
One significant change under the QMSR is the removal of exemptions that previously applied to certain records during FDA inspections. Under the QSR, management reviews and internal quality audit reports were excluded from the scope of documents that manufacturers were required to maintain and make available for FDA inspection.
But ISO 13485 does not provide similar exemptions from its recordkeeping requirements. Despite numerous comments from industry stakeholders requesting that the FDA maintain the confidentiality of these records, the agency decided to eliminate the QSR exceptions. The FDA reasoned that these records are already maintained as part of the regular course of business, and making them available for inspection should not be overly burdensome.
The FDA has indicated that it intends to modify its inspectional processes in line with this new rulemaking but has not provided specific details on implementing these changes. Therefore, whether the FDA will begin routinely inspecting management reviews, quality audit reports, and supplier audit reports under the QMSR remains to be seen. Historically, the FDA has maintained a policy of not reviewing internal quality assurance audits during routine inspections, and the final rule does not clarify whether this policy will continue under the QMSR.
We suggest firms begin by reviewing their current practices for documenting management reviews, internal quality audits, and supplier audits. Ensuring that all records are thorough, well-organized, and accurately reflect the company’s quality management activities will be essential. Any gaps in documentation should be addressed immediately.
A few other recommendations to consider here:
Make sure your internal audits and management reviews are rigorous—not just box-ticking exercises but genuinely contribute to improving quality and compliance. The records of these activities should clearly show that issues are identified, analyzed, and effectively resolved, with follow-up actions documented.
Implement confidentiality protocols. While firms must make these documents available for FDA inspection, they should also consider implementing confidentiality protocols to protect sensitive information. This might include limiting the distribution of these documents internally and ensuring that only necessary details are included in the records.
5. The QMSR may offer more flexibility in certain areas compared to the QSR
While the FDA has emphasized that the QSR and ISO 13485 are “substantially similar,” there are notable differences between the two standards. As a result, the QMSR may offer more flexibility in certain respects than the QSR.
For instance, under the QSR, each stage of the design review process must include at least one individual who is not directly responsible for the design stage being reviewed. This requirement is intended to provide an objective perspective during the review process. However, ISO 13485 does not include this specific requirement. Instead, it has a more general mandate that design reviews must include representatives of functions concerned with the stage under review, as well as other specialist personnel.
Under the QMSR, manufacturers will have the discretion to choose which individuals to include in each design review stage, potentially allowing for a more flexible approach.
6. The QMSR retains key QSR requirements for complaint records and labeling controls
To ensure alignment with the FDCA and other FDA regulations, the QMSR retains several provisions from the QSR that supplement ISO 13485. Notably, the QMSR includes specific requirements for complaint records that are consistent with the existing QSR provisions.
These additional requirements ensure that manufacturers maintain comprehensive records of complaints related to their devices, which are crucial for post-market surveillance and ongoing safety assessments. Additionally, the QMSR retains specific requirements for device labeling and packaging controls from the QSR.
While ISO 13485 does address labeling and packaging, the QMSR includes more detailed provisions to ensure these aspects are thoroughly inspected and controlled by the manufacturer, thereby preventing labeling errors and ensuring proper packaging of devices.
7. MDSAP audits may still substitute for routine FDA inspections
The Medical Device Single Audit Program (MDSAP) is a voluntary certification program where third-party auditing organizations conduct audits of participating medical device manufacturers based on core ISO 13485 requirements, along with additional country-specific regulations.
The FDA is a participant in MDSAP and has a policy that it “may” accept MDSAP audit reports in place of routine FDA surveillance inspections. The implementation of the QMSR does not alter the voluntary nature of the MDSAP or the FDA’s policy regarding MDSAP audit reports. This means that manufacturers participating in the MDSAP may continue to benefit from reduced regulatory burdens by potentially substituting MDSAP audit reports for routine FDA inspection.
8. ISO 13485 certificates will not replace FDA inspections
Many medical device manufacturers are audited by third-party organizations to comply with ISO 13485, receiving certificates upon successful completion of these audits.
But the FDA has clarified that it will not rely on ISO 13485 certificates for oversight of device manufacturers. This means that possessing an ISO 13485 certificate will not exempt a manufacturer from undergoing FDA inspections. Furthermore, FDA inspections will not result in the issuance of ISO 13485 certificates.
9. U.S. manufacturers without ISO 13485 experience may find the transition challenging
While harmonizing with ISO 13485 is expected to reduce administrative burdens and compliance costs for manufacturers operating in multiple jurisdictions, U.S.-based manufacturers that have not previously dealt with ISO 13485 may find the transition to the QMSR more challenging.
These manufacturers will need to adapt to new terminology, organizational structures, and procedural requirements that differ from those of the QSR. The FDA has described ISO 13485 and the QSR as “substantially similar,” but the differences in regulatory schemes may require significant adjustments in how U.S. manufacturers approach quality management. Companies that have not yet developed processes aligned with ISO 13485 should begin planning for the transition to the QMSR well in advance of the effective date in February 2026 to avoid potential disruptions.
Paid subscribers can download our compliance roadmap and QMSR gap analysis worksheet here.
10. The FDA’s approach to QMSR inspections isn’t clear
One of the most pressing concerns for industry stakeholders is how the FDA will apply the QMSR during inspections.
In response to numerous comments requesting clarification, the FDA explained that it plans to replace its current Quality System Inspection Technique (QSIT) with an inspection approach that aligns with the QMSR. The FDA has also indicated plans to update its IT systems, train personnel, and assess relevant regulations and documents impacted by this rulemaking.
However, the FDA has not provided specific details on what this new inspection approach will entail or when such details might be released. As a result, even companies familiar with ISO 13485 are left uncertain about how to align their processes and systems with the FDA’s expectations under the QMSR. This lack of clarity could make it challenging for manufacturers to fully prepare for FDA inspections, potentially leading to unforeseen compliance issues during the transition period.
A few recommendations for device firms
With less than 18 months to transition from the existing QSR to the new QMSR, here are a few things we’re suggesting firms start considering.
Develop a transition plan. This plan should include timelines for training personnel, updating procedures, and revising documentation to align with ISO 13485:2016. If a plan is not yet in place, we recommend contacting us or whoever you plan to work with to ensure you can secure the specialists you need on a manageable timeframe. Do not be one of the firms that waits just a few months before the effective date to rush a project like this.
Revise terminology and documentation. Firms should begin revising all relevant documentation and training materials to reflect the changes in the QMSR. Internal and external communications, training sessions, and documentation templates should be updated accordingly.
Prepare for broader FDA inspections. Under the QMSR, management reviews, internal quality audit reports, and supplier audit reports will no longer be exempt from FDA inspection. This is a significant change from the current practice under the QSR. Review and possibly enhance the quality and thoroughness of these documents to make sure they’re maintained in a manner that can withstand regulatory scrutiny. Then, run mock inspections to prepare for this increased level of oversight.
Take a close look at your complaint handling and labeling controls. Firms should review their current complaint handling processes and labeling controls to ensure they are compliant with both ISO 13485:2016 and the additional requirements outlined in the QMSR.
As the QMSR implementation date draws closer, the medical device industry will see a surge in demand for qualified regulatory consultants. We’re already seeing it start.
Talk to us to begin your QMSR transition
The FDA Group's QMSR compliance services are meticulously tailored to guide you through the FDA's latest regulatory updates, ensuring alignment with the ISO 13485:2016 standards.
Our team, comprising industry veterans and ex-FDA staff, offers unmatched expertise to secure your compliance with the newly finalized QMSR. This strategic alignment fosters global harmonization and enhances operational efficiency, setting a new standard for quality management in the medical device sector.
Having helped many firms with QSR and ISO 13485:2016 compliance, we offer a comprehensive suite of QMSR compliance services tailored to support medical device companies in navigating and adhering to the new regulatory requirements. Our services are designed to address the specific challenges posed by the QMSR, leveraging our expertise to facilitate a smooth transition. We help you allocate your resources more efficiently, ensuring that your transition to QMSR compliance is completed within deadlines and within budget without compromising day-to-day operations.
Our consultants offer an objective assessment of your quality management system, identifying potential issues and opportunities for improvement that internal teams may overlook.
Each QMSR support engagement is tailored precisely to your needs and can include, but is not limited to:
Regulatory Gap Analysis: We conduct an in-depth analysis of your current quality management system against the QMSR, identifying gaps and areas for improvement.
Customized Compliance Strategy: Based on the gap analysis, we develop a tailored strategy to address identified gaps, ensuring your systems are fully compliant with the QMSR requirements.
Risk Management Integration: If desired, our experts guide you in embedding risk management processes throughout your quality management system, ensuring compliance with the QMSR's emphasis on risk-based decision-making.
Documentation Updates: We assist in reviewing and updating your documentation, including SOPs, quality manuals, and records to meet the stringent documentation requirements of the QMSR and ISO 13485:2016.
Employee Training and Development: We provide targeted training programs to ensure your team is well-versed in the QMSR changes, their roles, and responsibilities within the updated system.
Preparation for FDA Inspections: With anticipated changes in the FDA's inspection approach under the QMSR, we prepare you for inspections through mock audits and readiness assessments, ensuring your team is confident and prepared.
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