FDA Finalizes New QMSR for Medical Device Manufacturers

The U.S. Food and Drug Administration (FDA) has finalized a new rule revising the quality system regulation (QSR) for medical devices to align with ISO 13485. The new rule, which amends 21 CFR Part 820, is referred to as the Quality Management System Regulation (QMSR). As the FDA explains, the QMSR is intended, “to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.”

For device manufacturers who are not familiar with ISO 13485, achieving compliance with the new QMSR may require a significant amount of work. While the new rule does not take effect until February 2, 2026, device manufacturers should review the new rule now and conduct a gap assessment to ensure that they will remain in compliance.

What Device Manufacturers Need to Know About the New QMSR

The new QMSR will present unique challenges for medical device manufacturers. Notably, while the QMSR broadly requires compliance with ISO 13485, FDA will not require device manufacturers to obtain certification. However, FDA will vigorously enforce the QMSR when it takes effect. To facilitate enforcement efforts, the FDA will be “training FDA staff responsible for assessing compliance with medical device quality management system requirements, developing an inspection process, revising relevant regulations and other documents impacted by this rulemaking” and making other changes.

The FDA notes that, “although ISO 13485, the QMSR, and the former QS regulation use some different terms, the requirements remain substantially the same.” However, this does not mean that compliance with the outgoing QSR will satisfy the QMSR. Complying with the new rule may require device manufacturers to take steps including, but not limited to:

• Revising existing quality control policies and procedures
• Restructuring operations to facilitate compliance with new policies and procedures
• Updating training materials
• Updating internal audit processes
• Amending contracts and agreements that reference the outgoing QSR

The language of the new rule, along with the preamble to the rule, should be used by device manufacturers (and their counsel) to develop compliance strategies. The FDA has not published additional guidance documents — though this may change as the effective date of the new QMSR approaches.

Conclusion

Medical device manufacturers should review FDA’s new QMSR to begin developing long-term compliance strategies and ensure that they are prepared to fully comply starting February 2, 2026. At Gardner Law, we rely on decades of relevant experience to assist device manufacturers with all aspects of FDA compliance. Our attorneys and FDA compliance consultant Tim Philips work closely with our clients to help them implement comprehensive compliance programs. Tim is a former FDA investigator and compliance officer with more than 30 years of experience in post-market compliance for medical devices. He is a valuable resource for those who want to avoid unnecessary scrutiny from the FDA. Contact us for more information.