The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation under 21 CFR 820.
Specifically, the new rule will amend the title of the regulation to the Quality Management System Regulation (QMSR) to modernize and harmonize the regulation by more closely aligning the standards in the federal regulation with the international standard for medical device quality management systems set by the International Organization for Standardization (ISO). The final rule will become effective Feb. 2, 2026, providing a generous two-year transition period.
In particular, FDA’s final rule maps more closely to the global industry standard ISO 13485:2016, to address quality system management throughout the medical device life cycle, including design and development, production, storage and distribution, installation, servicing and final decommissioning, and disposal of medical devices. This change supports FDA’s “focus[] on advancing and continually improving the quality, safety, and effectiveness of medical devices to meet patient needs.”
Throughout the two-year ramp-up period, FDA implementation activities will include updating information technology systems, training FDA staff who are responsible for assessing compliance on the updated requirements, developing an inspection process, revising regulations and communicating with stakeholders on the rule change. Despite costs associated with retraining staff and modifying existing internal processes, FDA estimates that the harmonization with ISO 13485 will result in an annualized net cost savings in the medical device industry of approximately $532 million to $554 million.
McGuireWoods attorneys can assist medical device manufacturers with gap analyses, risk assessments, training, vendor assessment and management, and compliance measures. Please contact one of the authors of this article for more information on how the QMSR will affect your medical device manufacturing processes.