Understanding FDA’s Risk-Based Inspection Model Under QMSR February 13, 2026 By Allyson B. Mullen & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert —

https://www.thefdalawblog.com/2026/02/understanding-fdas-risk-based-inspection-model-under-qmsr/?utm_source=rss&utm_medium=rss&utm_campaign=understanding-fdas-risk-based-inspection-model-under-qmsr Quality Management System Regulation (QMSR) became effective February 2, 2026 ( see our prior blog post about here). That same day FDA replaced the Quality System Inspection Technique (QSIT) for medical device inspections with a new risk-based inspection approach, as described in the updated Inspection of Medical Device Manufacturers Compliance Program Manual (CP-7382.850).