On January 31, 2024, the FDA issued its highly-anticipated Quality Management System Regulation (“QMSR”) Final Rule which amends current good manufacturing practices (CGMP) for devices under 21 CFR Part 820. The rule becomes effective on February 2, 2026 which provides manufacturers with two years to revise current processes, procedures, and practices as well as to provide training to applicable staff. The purpose of this rule is to align U.S. regulations with ISO 13485:2016, which is the international consensus standard for Quality Management Systems (“QMS”) for medical devices.
To achieve its objective of harmonizing U.S. practices with those of the international community for devices, the QMSR incorporates by reference the requirements set by ISO 13485:2016 Check out our Blog on ISO 13485, Five Things you Must Know. In addition to the incorporation by reference, there are some new requirements that serve simply to clarify certain concepts and expectations under the international standard including requirements for combination products. All in all, the major requirements for a QMS are not changing significantly under this Final Rule, as ISO 13485:2016 is substantially similar to the existing guidance under 21 CFR Part 820. Regardless, it is imperative for device manufacturers in the U.S. to ensure they have a thorough understanding of the details, concepts, and terminology under ISO 13485:2016, as well as the newly established clarifications under QMSR. Steps should be taken to identify existing gaps, if any, and develop an effective and efficient implementation plan to ensure timely compliance. It is also important to note that as part of these new requirements, the FDA will be developing a new inspection process which will be implemented when QMSR goes into effect. At this time, the FDA has not shared details regarding its new inspection process.
A link to the QMSR Final Rule can be found here. Link to Final FDA Rule
Are you interested in learning more?
