FDA Aligns U.S. Medical Device Quality System Regulation with International Standards

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) and harmonizing them with internationally accepted standards set forth in ISO 13485:2016. In the final rule, FDA reframes FDA’s QSR under the new monicker, “Quality Management System Regulation” (or “QMSR”) and aligns U.S. medical device regulatory requirements with ISO 13485, as most recently revised in…
By: King & Spalding