FDA Update: Final Rule Amending the Quality System Regulation

The FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation.

This rule amends 21 CFR 820 by incorporating by reference the quality management system requirements of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016.

The FDA has determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the QS regulation, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The rule amends the title of the regulation and establishes additional requirements that clarify certain expectations and certain concepts used in ISO 13485. These additions ensure that the incorporation by reference of ISO 13485 does not create inconsistencies with other applicable FDA requirements. This revised part 820 is referred to as the Quality Management System Regulation (QMSR).

This action continues the FDA’s efforts to align its regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.

The rule is effective two years after publication in the Federal Register. Until then manufacturers are required to comply with the QS regulation. The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.