REGULATORY UPDATE: FDA Releases QMSR Final Rule With Two-Year Implementation Period

The Food and Drug Administration issued a quality management system regulation (QMSR) final rule Jan. 31 that amends the agency’s device current good manufacturing practice (CGMP) requirements under its quality system (QS) regulation to more closely align with international standards.

Specifically, the QMSR final rule amends 21 CFR 820 to incorporate the quality management system requirements of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), 13485:2016. This change reflects the agency’s determination that the requirements in ISO 13485 are “substantially similar” to the requirements of the QS regulations described in 21 CFR 820.

In the final rule, FDA establishes additional requirements that clarify certain expectations and concepts used in ISO 13485 to ensure that their incorporation does not conflict with existing FDA regulations. The final rule also adjusts requirements for combination products.

FDA will begin to enforce the QMSR requirements on Feb. 2, 2026. FDA established new web page to provide answers to frequently asked questions related to the final rule.