On February 2, 2026, FDA’s new Quality Management System Regulation (QMSR) fully came into force, replacing the 30-year-old legacy standard 21 CFR Part 820. The new rule fully aligns with the global universal ISO 13485 standard and unifies quality management requirements across major global markets, while tightening audit standards for biocompatibility and post-market surveillance of Class II & III consumables. For global exporting manufacturers, complete compliant technical files, supplier traceability records and full-process production validation become mandatory entry requirements for the US market.