On January 31st, 2024, the Food and Drug Administration (FDA) issued the Quality Management System Regulation (QMSR) Final Rule to amend the requirements of the current medical device Quality System Regulation (QSR), 21 CFR Part 20. This amendment, which takes effect February 2nd, 2026, incorporates by reference the International Organization for Standardization (ISO) 13485:2016, a well-established medical device quality management system (QMS) standard used internationally by many regulatory authorities. The final ruling harmonizes the 1996 QS Regulation by converging the current FDA QS requirements with international quality management system (QMS) requirements—including ISO 9000:2015 Clause 3 (Quality Management Systems – Fundamentals and Vocabulary) and ISO 13485:2016—making this regulation amendment a historic step towards global QMS consistency.
The FDA explains that QMS expectations have not evolved since the current 21 CFR 820 (QS) Regulation was implemented over two decades ago, and thus adoption of the revised QMSR should advance and continuously improve the quality, safety, and effectiveness of medical devices to meet patient needs and more closely align the U.S. with many other regulatory authorities around the world.
The QMSR Final Rule amends the title of the regulation (QS Regulation to QMSR) and establishes additional requirements and clarifications of the expectations used in ISO 13485:2016, while also clarifying that any clauses that conflict with provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act shall be superseded by the FD&C Act. The Final Rule also makes conforming edits to 21 CFR Part 4 (Combination Products) to clarify QMS requirements; however, it is important to clarify that these changes will not impact the Current Good Manufacturing Practices (cGMP) requirements for combination products.
The rule becomes effective two years after publication in the Federal Registrar. Therefore, the FDA will begin enforcing the QMSR requirements on February 2nd, 2026.