For years, many medical device manufacturers approached U.S. Food and Drug Administration (FDA) inspections through a familiar lens: Prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against a known framework. That approach was shaped by the long-standing quality system regulation (QSR) and quality system inspection technique (QSIT) models, which often organized inspections around defined subsystems.

That landscape has changed. The FDA’s quality management system regulation (QMSR) is now in effect, replacing the previous QSR framework and aligning U.S. device quality requirements more closely with ISO 13485:2016 while retaining important FDA-specific expectations. At the same time, inspections conducted on or after Feb. 2, 2026, moved away from the traditional QSIT model toward a broader compliance program centered on how quality systems operate in practice.

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