FDA’s QMSR Recognising ISO 13485:2016: A New Era for MDR

On January 31, 2024, the FDA issued a landmark final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820. This amendment aligns the QS Regulation more closely with the international standard ISO 13485:2016, used globally for medical device quality management systems. The new regulation, now referred to as the Quality Management System Regulation (QMSR), marks a significant step towards harmonising U.S. regulations with those of other international regulatory authorities, thereby promoting consistency and efficiency via regulatory convergence.  

Background and Implementation Timeline 

The FDA’s final rule incorporates, by reference, the requirements of ISO 13485:2016 into 21 CFR 820. This integration recognises that ISO 13485 provides a comprehensive framework similar to the QS regulation, ensuring a robust quality management system capable of consistently producing safe and effective medical devices in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

The QMSR will become effective on February 2, 2026, two years after the Final Rule amendment, giving manufacturers a period to align their quality management systems with the new requirements. During this period, manufacturers must continue to comply with the existing QS regulation.​  

Key Changes and Clarifications 

The QMSR not only adopts ISO 13485 but also includes additional requirements to address specific FDA expectations and ensure there are no inconsistencies with other FDA regulations. For instance, the QMSR provides clarifications on certain concepts and integrates specific requirements to maintain alignment with the FD&C Act. Additionally, the FDA has made conforming edits to part 4 (21 CFR part 4) to clarify the Quality Management System (QMS) requirements for combination products, ensuring these edits do not impact CGMP requirements for these products.​ 

Impact on Manufacturers and FDA Operations 

The harmonisation effort is expected to streamline regulatory compliance for manufacturers, particularly those operating on a global scale. By aligning with ISO 13485:2016, the QMSR eliminates the need for dual compliance, thus reducing the regulatory burden. However, US and ROW manufacturers not in compliance with ISO 13485:2016 will need to update their quality procedures, internal audit processes, and training programs to meet the new standards if intending to operate with the US.​ 

FDA staff will undergo extensive training to familiarize themselves with the new QMSR and the revised inspection processes. This includes updating information technology systems, revising relevant regulations, and engaging in stakeholder communication and education to ensure a smooth transition. 

Inspection and Future Revisions 

The FDA will develop a new inspection process aligned with the QMSR requirements. These inspections will continue to protect public health by ensuring compliance with the revised regulation. Should ISO 13485:2016 undergo future revisions, the FDA will evaluate the changes and determine whether amendments to the QMSR are necessary, implementing any needed adjustments through rulemaking.

Summary

The FDA’s adoption of the QMSR represents a significant advancement in the regulation of medical devices, fostering global harmonisation and enhancing the quality and safety of devices. By aligning with ISO 13485:2016, the FDA aims to streamline compliance processes and reduce the regulatory burden on manufacturers, ultimately benefiting patients with the timely availability of safe and effective medical devices. 

As the 2026 implementation deadline approaches, it is crucial for medical device manufacturers to start preparing now. This preparation includes updating quality management systems, training staff, and ensuring all procedures align with the new QMSR requirements. A proactive approach will facilitate a smooth transition and maintain the highest standards of safety and effectiveness in the medical device industry. 

Our Medical Device experts at DLRC are standing by to support you. To discuss your requirements with our regulatory experts, email us at hello@dlrcgroup.com.