The US Food and Drug Administration (FDA) has published the long-anticipated final rule on Quality Management System Regulation (QMSR), aligning its requirements with the widely recognized International Organization for Standardization (ISO) standard. The move aims to establish consistency in regulatory expectations for device manufacturers across different regulatory regimes, leading to significant cost savings for the industry. Published on January 31, the QMSR final rule amends the FDA’s current medical device good manufacturing practice (CGMP) expectations under its quality system (QS) regulation to conform with ISO 13485:2016.

FDA’s Center for Devices and Radiological Health (CDRH) puts emphasis on importance in promoting global harmonization in device regulation. This, in turn, ensures timely and continuous access to safe, effective, and high-quality medical devices worldwide. By aligning key aspects of a medical device manufacturer’s quality management system with the international standard, the FDA aims to simplify compliance requirements across multiple regulatory authorities.

Industry stakeholders have until February 2, 2026, to comply with the new rule while maintaining the option to adhere to current QS regulations until the deadline. The FDA highlighted the substantial similarities between the requirements in ISO 13485 and its QS regulation, ensuring a comparable level of assurance regarding medtech manufacturers’ compliance with regulatory expectations. The new rule retains the scope of the QS regulation while introducing amendments to various provisions.

In addition to incorporating ISO 13485 requirements, the FDA has updated the title of the regulation and introduced additional provisions to clarify specific expectations and concepts. The agency recognizes ISO 13485 as a foundation for regulatory harmonization programs, such as the Medical Device Single Audit Program (MDSAP), involving participation from multiple countries.

While the existing QS regulation effectively addresses FDA’s quality management system requirements, it lacks the detailed specifications desired for the design and manufacture of medical devices. The QMSR aims to provide this level of detail while enhancing harmonization efforts across regulatory regimes.

The QMSR is not about introducing new requirements but explicitly incorporating existing requirements into the regulations. The update does not create inconsistencies with other regulatory requirements, and it clarifies device Quality Management System (QMS) requirements for combination products without impacting CGMP requirements for such products.

For more details, refer to the following link: https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments