Lexology February 8, 2024
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...
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