February 24, 2026

FDA’s New QSMR Inspection Program (CP 7382.850) — And How It Differs from QSIT

On February 2, 2026, FDA formally implemented Compliance Program 7382.850 – Inspection of Medical Device Manufacturers, aligned with the new Quality Management System Regulation (QMSR).  This program replaces the prior inspection model that industry knew well: QSIT (Quality System Inspection Technique). For device manufacturers, regulatory professionals, and quality leaders, understanding this shift is critical. This […]