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The Food and Drug Administration (FDA) issued a final rule on January 31, 2024, to amend the medical device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation defined in 21 CFR Part 820 to harmonize and modernize the regulation. The reason for the change is to align more closely with the international consensus standard for devices, ISO 13485, 2016 edition, by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). This will be accomplished by incorporating reference to the quality management system requirements of ISO 13485, an international standard specific for device quality management systems. Through this rulemaking the FDA will also establish additional requirements and make conforming edits to clarify the device CGMP requirements for such products. The title of the regulation will also be amended as the Quality Management System Regulation (QMSR). The effective date for enforcement is February 6, 2026. These edits do not impact the CGMP requirements for combination products.

Posted in FDA and USDA Regulatory Update, Medical Devices.